A modified video-feedback intervention for carers of foster children aged 6 years and under with reactive attachment disorder: a feasibility study and pilot RCT

Initial adaptation of the VIPP-SD programme for the foster care population

Although the Leiden group’s original version of VIPP-SD for foster care was tailored to be appropriate for children in foster care,28 the adaptation undertaken in the Dutch context did not reflect the UK setting; as previously noted, the majority of changes recommended by the Manual Development Working Group reflect these differences in context and practice between the UK and the Netherlands. Before outlining the second phase of adaptation for the UK context, we summarise the main differences between the original VIPP-SD manual and the adapted VIPP-FC manual, as adapted by the Leiden group for the Dutch foster care context.

On the whole, the original VIPP-SD manual and the VIPP-FC manual were very similar, with similar tasks, visits and messages. However, the VIPP-FC manual included some extra key themes introduced in the manual specifically for foster children:

• Additional content highlighting that foster children do not always show what they are feeling, as they may not be used to having their needs met, hence the need to address the more subtle signals of the child.

• Additional content about not asking for help – children in foster care do not always behave in the ways that carers would expect them to, hence the need to react to the absence of attachment behaviour as well (e.g. if they do not cry when they hurt themselves, the carer should show them attention anyway to demonstrate that they can be trusted when something is wrong). These were added by the Leiden developers to encourage children to learn that they can rely on their carers. These modifications, in particular, relate to difficulties in the domain of RAD symptoms.

• Additional content regarding the importance of physical contact – how it can cause anxiety for children who have experienced maltreatment and how gently encouraging it can help them overcome these anxieties, particularly if it is done in a structured and sensitive way (such as a song involving touch).

• Additional content encouraging carers to compliment/praise small steps in the right direction – this is even more important for allowing foster children to know that they are doing something right.

• Additional content about strategies to manage indiscriminate friendliness.

• Alternative tasks to those in the original manual; for example, some short extra tasks were added that involve physical touch in a game/song to introduce physical touch in a safe way for the child.

• ‘Don’t touch’ task puts more emphasis on maintaining eye contact with the child than in the original VIPP-SD version, and also a suggestion of naming a book or toy to play with after they have calmed down so that they can more easily imagine the reward they will receive if they are able to wait.

Revisions to the VIPP-FC manual: the work of the manual development group

The modifications made to the VIPP-FC manual for this study were based on discussions within and feedback from the Manual Development Working Group, as well as on learning acquired during the case series, feedback from which was also reviewed by the Manual Development Working Group (see Chapter 3). Some modifications reflect changes to the manual itself, such as the wording of certain messages or tasks, whereas others have to do with the broader context for delivery of the intervention, such as introduction of forms and letters to aid in the delivery of the VIPP-FC in UK mental health services. There follows a summary of all of these modifications:

• An additional guidance document was written to be used alongside the manual for interveners working with specific types of carers/children. This document aimed to guide interveners on where they should adapt their wording to ensure that the language they use is sensitive and tailored to the circumstances of a child and their foster carer; for example, the VIPP-FC manual regularly asks the intervener to refer to the child having had ‘previous adverse experiences’, but this was considered not always appropriate for some carers, such as when the carer is a relative of the birth parent or when the carer has had the child since birth. The four main groups that required the modified wording were (1) a child in a SGO, (2) a child in kinship care, (3) a child who has been with the family since birth and (4) a child who is likely to stay with the family on a long-term basis. As an example, for the fourth group of children, we removed a paragraph that referred to the importance of the carer’s relationship with the child even if they were not going to remain with them long term.

• Following feedback from the Manual Development Working Group, we changed the word ‘obey’ to ‘do what you ask them to do’ throughout the manual as it was felt to be a little outdated and because it has negative connotations that contrast with the sensitive parenting that the VIPP-SD is trying to encourage.

• We shortened the manual to from seven to six visits as it was deemed more suitable for the sometimes short-term nature of placements within the population of foster children and to minimise the chances that the intervention work would be disrupted by a change in placement. The timing of the last two visits was also changed so that there was only a 2-week gap instead of a gap of 3 or 4 weeks, again to ensure that the programme could be finished relatively swiftly.

• A games booklet was introduced to the manual (adapted from a version created by the Tavistock and Portman NHS Foundation Trust for use with adopted families) to give to the carer in visit 4, which includes numerous songs involving actions and touch for the carer to use as a resource with the child (and with other children they may care for currently or in the future).

• The Goal-Based Outcome form was incorporated into the manual. This change reflects a standard requirement in CAMHS in the UK, where this form is used as a routine outcome measure and has also been incorporated more generally into clinical practice. The Goal-Based Outcome form is completed during a discussion with the carer in visit 1, to gauge and manage their expectations and goals for the programme, and to reframe or find common ground from which to work if their aims are out of the scope of the programme. The intervener also completes a final Goal-Based Outcome form with the carer at the end of the programme in visit 6 to assess if and how the goals were met, and if not, why not.

• Some extra guidance was added for the intervener supporting them in explaining or framing the importance of the work, even if the placement is expected to be short. The guidance helps the practitioner to explain that research supports the view that responsive and sensitive care is important for children even when relationships do not last, and that the relationship they build with them in this early stage of life can act as a foundation for the child’s future relationships and well-being. This was to counter beliefs that foster carers might have that it is best not to ‘bond’ with the child if they are not likely to be with them long term, and to help them understand how important it is for the child to experience warm and supportive care, regardless of the length of the placement.

• In keeping with the need for close communication between members of a child’s professional team, a closing letter was introduced in which interveners are instructed to write a letter about how the programme went, what improved and what issues may still require support at the end of the programme, which is sent to the social worker, copying in the foster/kinship carer.

• All names of Dutch games/songs were changed to English ones and additional instructions were added to explain how they worked, in case carers were not familiar with them.

• Photograph booklets were provided for the carer and child at the end of the programme with stills from their VIPP-FC/research videos depicting memorable moments of shared sensitive interaction. It was decided that this booklet with stills was a more acceptable option than providing the video clips themselves, owing to the complexities of consent and data protection of video material in this population.

As previously mentioned, the majority of these modifications were introduced during the initial phase of the work of the Manual Development Working Group, and some were added after the Manual Development Working Group considered feedback from practitioners and supervisors after the case series cases were completed. Although the manual was open to further modifications on review of the RCT cases, no additional changes were deemed necessary to the manual and programme themselves. Nevertheless, challenges with interveners’ capacity and availability, as well as interveners having dual roles in some cases (e.g. interveners who also worked in other roles in the local authority or mental health service provider), throughout the RCT led to discussion of the best model for the delivery of the VIPP-FC, which we return to in Chapter 8.

Ethics considerations

Two key ethics issues required careful consideration in this study: consent and the RAD label/diagnosis. The determination of who must provide consent for a child in foster care to take part in a research study and how this should be done is recognised in the literature as a complex problem. 35 An important aim of the current study was to investigate the range of views on how this should be achieved, from local authorities in different regions and from parents and carers. However, the starting point for the purposes of this study was to follow a procedure used in another NIHR pilot trial being conducted by our group for older children in foster care [aged 6–16 years; NHS Research Ethics Committee reference number 15/EE/0032; award ID: PB-PG-0614-34079 (https://fundingawards.nihr.ac.uk/award/PB-PG-0614-34079)]. The consent protocol for that study was developed from a review of the literature and consultation with a local authority director of social care and their legal department. The general principle informing the protocol was that written, informed consent to take part in the study must be received from all parents and from the local authority when holding parental responsibility, and that every effort should be made to secure the consent of parents when they do not have sole legal parental responsibility.

On the basis of these considerations, to take part in the intervention phase of the study (i.e. after initial screening), parents of children on full care orders were sent information sheets and an opt-out letter (with a 14-day period for opting out) in all but exceptional circumstances. Specifically, children on a full care order could enter the study without parental consent if the local authority [which shares parental responsibility with the birth parent(s)] deemed it not in the child’s best interests to seek it, or when every attempt had been made to inform parents of the study and to secure consent, but this had failed. For all other children, full written consent was obtained from the child’s parent(s). The child’s social worker initially made contact with the parent(s) and provided parents with the information sheets. It was at the discretion of the social worker whether to seek verbal consent for parents’ contact details to be passed on to the research team so that a meeting could be arranged to sign the full written consent or to seek the full signed consent from the parents themselves. In either case, the research team’s contact details were always provided to parents in case they wished to ask more in-depth questions. Active refusal of consent by a parent was always respected, regardless of the care order. Furthermore, a parent’s decision to withdraw their child once the child had started in the study was always respected, regardless of the care order.

Full informed consent was obtained from all participating foster carers and from the local authority. As the children were all aged ≤ 6 years, they did not provide written consent, but the researchers were trained to obtain verbal assent in an age-appropriate fashion for children old enough to do so (age ≥ 4 years).

Throughout our discussions with colleagues in the local authorities, a recurrent theme was professionals’ concerns regarding the diagnostic term ‘RAD’. In particular, professionals expressed conerns that if this diagnosis became a part of a child’s social work record, this may have direct implications for the child’s subsequent care, including their likelihood of being adopted. For a more in-depth discussion of this issue, see Chapter 4: stakeholder interviews drew attention to the potential difficulties associated with using diagnostic terms and a diagnostic criterion as part of the eligibility criteria for entry to the study, as well as the complications associated with information-sharing regarding diagnoses.

Because we included children presenting with varying degrees of RAD-type behaviour and as our assessments were based on research instruments rather than full clinical assessments, we did not use the term ‘RAD’ in our communications with participating families (e.g. in participant information sheets or verbally) to refer to the set of behaviours the study was focused on. Instead, we described the specific behaviours that are considered under the rubric of RAD, which tend to carry fewer unhelpful connotations (e.g. difficulties in seeking comfort from available caregivers). The same avoidance of diagnoses applied to written correspondence with foster carers and social workers about each child.

Target population

The target population was children in foster care aged between 11 months and 6 years, and their foster or kinship carer(s).

Eligibility criteria

Recruitment

Sample

For this (non-randomised) case series, we aimed to recruit six cases for piloting the clinical intervention, and testing screening and assessment procedures. As noted previously, we proposed to include a mixture of cases obtaining high RAD scores on the screening measures and cases falling below this threshold to explore whether or not the intervention required adjustment for these groups of children, and to maintain the pace of manual development in the event that prevalence was lower than expected.

Screening measures

There is no pre-existing established tool to screen for RAD. This is a significant gap in health technology in this field, as early detection may be critical for improving outcomes for children in care. In this study, we used two different instruments that each have their individual limitations, but may be useful in combination for screening for symptoms of RAD. The Attachment Screening Assessment (ASA) (Danya Glaser, Saul Hillman, Yael Shmueli-Goetz and Vivian Prior, the Anna Freud National Centre for Children and Families and UCL, 2013, personal communication) is a new instrument designed specifically to capture behaviours reflective of the DSM-5 symptoms of RAD and DSED, as well as standard Ainsworth-type attachment classifications. 37 In pilot work (Ching Yiu Ng and Saul Hillman, the Anna Freud National Centre for Children and Families and UCL, 2015, personal communication), the RAD items in particular have been found to discriminate well between children in care and those from the community, as well as children with greater overall psychopathology on the Strengths and Difficulties Questionnaire (SDQ). However, the ASA has thus far not been validated against formal diagnostic assessments, which limits the extent to which it can be used alone as a screening measure. The Development and Well-Being Assessment (DAWBA) includes a recently revised set of items for DSM-5 RAD. 38 We proposed to use these two instruments so that we could test the optimal configuration of measures for case identification.

Primary outcome: attachment measure

The DAI is a semistructured interview to evaluate the presence of signs of disordered attachment. 39 For each of 12 sections, the interviewer asks multiple questions and follows up with probes sufficient to yield a rating reflecting the degree of evidence of disturbed or disordered attachment: 0 = none/never, 1 = somewhat/sometimes and 2 = considerable/frequently. The first five sections of the interview address signs of emotionally withdrawn/inhibited attachment disturbance (i.e. RAD), yielding total scores ranging from 0 to 10 points. The inhibited attachment disturbance items are 1 – does not differentiate among adults, 2 – does not actively seek comfort when hurt/upset or does not seek comfort preferentially, 3 – does not respond to comfort when hurt/frightened, 4 – does not respond reciprocally with familiar caregivers and 5 – does not regulate emotions well. The next three sections address signs of indiscriminate behaviour and the last four sections address other signs of disturbances in attachment behaviour (known as ‘secure base distortions’). There is sound evidence for the validity of this measurement system. First, it distinguishes between institutionalised and non-institutionalised children, reliably identifies signs of attachment disturbance in maltreated children and validly distinguishes RAD from DSED. 5,39–41 Second, it has shown very good inter-rater reliability and high levels of internal consistency. 39,40,42 Third, criterion validity has been demonstrated through the convergence of attachment disorder diagnosis by different measurements. Construct validity has also been demonstrated by the association of DAI ratings with quality of care. 43

Secondary outcome measures

Broader impact measures

To assess quality of caregiving, we rated the observed carer sensitivity and other related parameters of parenting (e.g. co-operation, positive regard for the child). We used standardised observational procedures for assessing carer sensitivity during free play and routine caregiving interactions. Specifically, we video-recorded an interaction between carer and child for 10 minutes (excluding instructions), during which a set of structured instructions given to the carer were followed: (1) to teach the child how to play with a challenging toy for their age, (2) to then play with the child using no toys, (3) free play with the toys and (4) to help the child tidy up the toys. These video-recordings were subsequently scored blind to treatment condition and status (pre vs. post) by trained and reliable coders. The scoring system used was the National Institute of Child Health and Human Development (NICHD) sensitivity scales, which have been validated in numerous studies. 45

We also administered two parenting-related questionnaires. The Parenting Stress Index-Short Form was used to assess carer well-being, carer strain and the carer–child relationship. 46 The Brief Parental Self-Efficacy Scale is a measure of beliefs and confidence about parenting skills. 47

The Child and Adolescent Service Use Schedule (CA-SUS) assesses resource use for health economic evaluation. 48 Previous versions of the CA-SUS measuring service use by pre-school children with autism and young looked-after children formed the basis of a modified version suitable for the current population, with modifications being determined, initially, by expertise in the research group and, subsequently, by testing for acceptability and comprehensiveness. Specifically, this initial draft version was tested and modified in two ways. First, after a sufficient number of cases, the interviewers and the CA-SUS authors discussed necessary amendments and clarifications that were incorporated into the previous (draft) version. Second, the measure’s comprehensiveness in capturing all relevant services was assessed. Testing was important to identify items that were redundant or important services that had been omitted.

The proposed battery of outcome assessments was similar to those we have used in other trials and cohort studies,25,49,50 and our previous experience was that it would not be excessively burdensome. However, we planned consultation with foster carers (through the foster carers advisory group), as well as with those taking part in the study, regarding the level of acceptability and burden. Establishing the optimal balance between participant time/burden and the robustness of the outcome assessments was an important aim of this project as preparation for a full-scale trial.

The research team attempted to follow-up all families involved in the study, including children who moved to a different placement during the time of the research. Any additional relevant consent that was required as a result of placement changes was obtained (e.g. consent from the new carer).

One of the aims of the case series was to establish initial feasibility of the intervention protocol and the acceptability of the programme and outcome assessments to foster carers. Accordingly, research assistants closely monitored the recruitment and assessment processes and requested continuous feedback from carers to make any necessary adjustments to the protocol for the feasibility RCT (phase 3). In addition, treatment progress and process were closely monitored, and feedback was presented and discussed by the Manual Development Working Group (from phase 1) to allow consideration of further appropriate manual modifications. Practitioner feedback forms were used to provide additional qualitative feedback about the experience of using the VIPP-FC in practice. The results of the case series also informed revision of the research protocol in preparation for phase 3.

Intervention

Screening response rates

We present the overall response and retention rates in the form of a Consolidated Standards of Reporting Trials (CONSORT) flow diagram in Figure 1. As is evident from the diagram, we achieved a relatively good response rate of 60%, or 12 out of 20 carers.

FIGURE 1.

The CONSORT flow diagram for the case series.

Treated cases

Of the nine children whose carers completed the DAI, only three were eligible to proceed to treatment (see the reasons for exclusion in Figure 1). These three children underwent all baseline assessments with their carer. After the assessments were completed, one of them left the study because the child’s birth parents (who had received opt-out letters) contacted the social worker to refuse the child’s participation.

Hence, two children went on to receive the VIPP-FC, each provided VIPP-FC by a different CAMHS practitioner. They both completed all six sessions and all of the follow-up (i.e. post-treatment) research assessments.

Process observations: recruitment and consent

It is important to note that the 60% return rate was achieved only after substantial effort, which involved the study team calling social workers multiple times and asking them to encourage carers to return questionnaires, which, in turn, often required social workers speaking to carers several times. Another key learning point from the case series was that only a very small proportion (15%) of those potentially eligible (i.e. the 20 included in the mail-out) were eligible and willing to consent to the second stage of the study, during which they would receive the intervention.

Although return of the questionnaires was challenging, once we were in direct contact with the foster carers, they were generally very willing to hear more about the study and to take part in the subsequent stages. In spite of that, six out of the nine who completed the post-screening interview were, for various reasons, ineligible to take part in the baseline/follow-up assessments and receive the intervention. The feedback of those who took part in the more comprehensive assessments (i.e. at baseline and follow-up) was that these were acceptable and not overly tiresome.

Before and during the recruitment period, a member of the research team attended social worker and supervising social worker meetings to disseminate the study and encourage their involvement. Social workers appeared interested in the research and, in some instances, were able to identify cases that were potentially appropriate for taking part. On the other hand, some negative reactions were also experienced, such as disappointment regarding the limited age range of the target population and some confusion regarding the nature of the clincal presentation we were focusing on. Attempts to join foster carer groups were not successful.

The research team was able to explore and record the reasons for refusal from the birth parents who withdrew consent for their child’s participation, because the father consented to a member of the research team contacting him. The reasons for refusal provided by the father can be summarised as (1) frustration and anger at the local authority for having removed the child from his care; (2) an unwillingness to ‘help’ the local authority and what was seen as one of its partners (the research team); and (3) an unwillingness to allow a service to be offered to the child in the context of his relationship with his current (foster) carers, which was seen as contributing to the quality of the placement. The local authority and the TSC, in response to this, raised the more general question of whether or not there were circumstances in which parents may be considered to be not acting in the best interests of the child, for example when there has been limited contact and there are fraught relationships with the local authority. The TSC recommended that this issue be raised with the Research Ethics Committee. On discussion with the chairperson of the Research Ethics Committee, we agreed a revision of the initial consent procedure for cases on a full care order. Specifically, for the subsequent rounds of recruitment, local authorities were instructed to consider carefully if any birth parents with a child on a full care order might not be in a position to act in the child’s best interests. In such circumstances, the local authority could be permitted to give consent unilaterally.

Process observations: joint working with the local authority

This project involved working closely with the children’s services within a local authority; indeed, the initial step of making contact with foster carers and parents could be completed by the local authority only. Therefore, the study team needed to establish a strong partnership with the local authority, and considerable effort was focused on working and continuously improving the collaboration with the local authority to support the smooth running of the study.

Although the case series involved a single local authority only, a number of key practical implementation issues arose that were critical to consider in preparing the subsequent pilot RCT in other sites. Here we summarise the main findings regarding implementation with respect to the screening process and joint working with the local authority:

• The importance of social worker involvement and agreement – social workers play a central role in implementing a workable screening system in this context. At least two key issues arose in this respect. First, information in local authority digital records was not always up to date, and social workers sometimes held the most up-to-date information about children and their situations, including details and nuances about children’s placements and plans that might not be possible to gather from their electronic files. Because children’s circumstances can change quite often and quickly, close liaison with a child’s social worker was critical. This was not always easy, as social workers were generally very busy and were not always able to return telephone calls or reply to e-mails. This link to social workers for rapid communication of important case information or updates regarding location or suitability of cases is a critical potential vulnerability and a considerable amount of study team time/resourcing was required to make this work. Under-resourcing this aspect of project infrastructure could jeopardise a trial. Second, as representatives of the child’s interests, individual social workers’ agreement or ‘approval’ for a child’s participation in the study was generally expected (by the social workers themselves and, often, by the foster carers), even if someone with the relevant authority had granted permission already. This reinforces the importance of close working relationships with the children’s social workers, as well as the wider team within the local authority.

• Importance of the role of a ‘link’ member of staff – it was clear during this work that it is essential to have a contact person at the local authority who links the study team to the rest of the children’s services team. In the first study site, an internal member of staff at the local authority (initially, a senior social worker and, at a later stage, an administrative support worker) fulfilled this role of connecting the study team and the children’s services. Owing to the changing and somewhat unpredictable environment of these settings, it may not always be realistic to maintain a continuous dialogue with a large number of members of staff working directly with children. Therefore, this ‘link person’ is crucial to make communication effective and not diffuse responsibility for taking the project forward within the local authority. It is likely to be helpful if this is the same person who is designated to undertake the administrative tasks required for recruitment of participants to the study, namely obtaining a list of potential participants, mailing out letters and screening packs, and contacting carers.

• Limited resourcing – it was clear from the first phase of work that local authorities’ resources are limited and that social workers and support staff tend to be under considerable pressure and have little time available to dedicate to a research project, despite their willingness in principle. We made extensive efforts to make sure that the study was ‘on the radar’ of colleagues in the local authority, but the sheer volume of work they face often slowed study procedures significantly (obtaining up-to-date lists of potential recruits, gaining local authority consents, sending out letters, speaking to foster carers on behalf of the study team, etc.). We explored the possibility of bringing a member of the research team into the local authority to support these administrative activities and to lessen the impact on core staff (e.g. from within our team or a clinical support officer from the Clinical Research Network). However, we faced some anxiety from the local authority about allowing an external person into the authority (with an appropriate honorary contract/appointment in place) to support its participation in the study. The reluctance to pursue this possibility appeared to be partly apprehension about governance and training issues, but was also related to an unwillingness to invest the time required to set up such a contract, which was perceived to be an arduous bureaucratic process.

• Lengthy delays in obtaining data from the local authority – gathering information and, particularly, obtaining a list of potential participants (even with relatively simple criteria, such as children aged ≤ 6 years in certain types of placement) took longer than anticipated, usually at least several weeks after all the agreements had been put in place and the go-ahead had been given by a relevant senior manager to generate a list. Therefore, recruitment needs to be planned well in advance and with this time frame in mind. Because children’s circumstances can change quite rapidly, this can also mean that the list becomes out of date by the time it is acted on and may need updating.

• Researcher presence at social workers meetings – we expected that it would be important for the research team to attend social workers’ team meetings to disseminate the study and engage social workers and supervising social workers. It was clear that it would not be enough to go to a single meeting as the study could quickly become forgotten and we would not be able to meet all staff in a single meeting. However, we found that getting invited to these meetings was a challenge in itself, despite the local authority’s willingness to invite the team in principle. Our impression was that this largely reflected the very busy working environment and the stretched resources within local authorities.

• Lack of availability of social workers – social workers (particularly children’s social workers) tended to be extremely busy and were often away from their desks on home visits. They were, in the majority of cases, difficult to reach by e-mail or telephone. It was clear that the study would work best if it relied on them as little as possible and used what little time they had available for the most critical functions. For example, it did not appear to be feasible to ask individual social workers to mail out screening packs or to ask foster carers to return the packs via the social worker. Furthermore, although relying on individual social workers to follow up on questionnaire completion from carers is often necessary, it is important to also have alternative strategies in place to supplement that work (e.g. having an administrator in the local authority to make direct telephone calls to carers).

• We tended to find that supervising social workers were easier to get a hold of and could be very helpful in following up foster carers about screening questionnaires. They were also interested in promoting the study as an aspect of improved foster carer training.

• Social workers appreciated receiving feedback from the research assessments, which, in some cases, could be incorporated into relevant clinical reports about the child.

• Finally, we had no success recruiting from foster care agencies, partly because we would still be dependent on the local authorities to obtain consent to screen specific cases and partly because they were difficult to engage. Therefore, we were not able to recruit any cases through these agencies, despite contacting > 40 of them.

Process observations: working with foster carers

• Foster carers tended to be very busy, often caring for more than one child, and were responsible for completing a great deal of paperwork for the local authority as part of their formal role responsibilities. This was a challenge for the completion of the screening questionnaires and some foster carers fed back to us that if there is no one specifically highlighting the study, then questionnaires may just be ‘thrown on the pile’. The feedback reinforced the importance of promoting the study at multiple levels and in multiple forums, and, in particular, the importance of finding ways to encourage social workers (supervising social workers and children’s social workers) to promote the study directly to foster carers.

• Foster carers tended not to take the initiative to contact the research team if they had questions. In several instances, foster carers had queries about the questionnaires or about whether or not they were allowed to take part [i.e. whether or not the local authority had approved it (even though the cover letter indicated that it had)], but did not use the contact details provided to ask them. Follow-up telephone calls from the local authority on behalf of the research team were very important in these cases.

• Virtually no foster carers completed the research questionnaires without some chasing from the children’s social worker or the supervising social worker (or both), often on several occasions.

• Social workers’ encouragement of foster carers to complete the questionnaires was vital, but, given that it was very challenging to get social workers to do that, we proposed a protocol amendment to the Research Ethics Committee to allow us to contact foster carers directly if they gave the local authority/social worker verbal consent for us to do so. This was very helpful as it gave the research team the opportunity to follow up on the questionnaires, clarify any doubts and show that they were available to help, and to do so without depending on a social worker to make several calls on their behalf. We suspect that making direct personal contact in this way was also reassuring to foster carers and helped build a direct relationship with the study team.

• Some foster carers did not complete the questionnaires because they thought that the child would not be eligible for several reasons. This would tend to mean that non-completion could be non-random and selectively over-represented by low-scoring cases. This may be less of a problem for simply identifying cases, but is problematic for estimating the proportions of cases meeting RAD criteria. We tried to mitigate this in preparation for the RCT by emphasising in the information sheet that we were keen to hear from all foster carers, including those caring for children who did not have any emotional difficulties, but it was unclear how much impact this information had.

• We concluded in discussions with our foster carer team member that an incentive to return questionnaires, in the form of a voucher offered to the carer, might help with return rates; although we could not implement this in time for the case series, we were able to introduce this change to the feasibility RCT.

• Research assessments – the baseline and follow-up assessments took longer to complete than initially expected. To manage this, we implemented a number of strategies that generally worked well. Specifically, to make the study visit of a manageable duration, we offered flexible options for completing any assessments that did not require a formal assessment/laboratory context to complete (i.e. all but the Strange Situation Procedure and interaction observation). Thus, we offered families the opportunity to complete paper questionnaires before the visit and to complete the DAWBA online at home, as well as the opportunity to pay a second visit to a carer’s home to complete these, if needed. We explored the possibility of doing the DAWBA or the DAI over the telephone, but concluded that this was not feasible, as reading aloud the questions and options for the former took too long, and being unable to see and establish rapport with the interviewee made the latter more challenging.

• Foster carers appreciated receiving feedback about the assessments and found it helpful. This also proved to be very valuable for social workers, both for their own use and because they appreciated the support it offered foster carers.

• Although based on a very small number of cases, we found that, once initial contact was established and the team met foster carers in person, foster carers tended to remain engaged with the study and complete all of the assessments and all VIPP-FC sessions.

Process observations: working with parents

• Parents often did not live at the same address; thus, the decision of whom to send the information letter to (i.e. one or both parents) was made by the local authority.

• Even though the research team was available to seek consent from birth parents directly and in person, social workers preferred to be the ones requesting consent from parents in person, usually when they were meeting them for other reasons. However, this meant that obtaining written consent from parents could take a long time, as we had to wait for the social workers to obtain this.

• Although parents have a right to refuse consent for their child to take part in the study, we encountered an example in which the local authority considered that the parents were refusing for reasons that the authority deemed were not in the child’s best interest. Clearly, in some cases, relationships between parents and the local authority can become strained and parents may have limited involvement in their child’s life. After discussion with the local authority and the TSC, we met with the chairperson of the NHS Research Ethics Committee, who advised us that the protocol provided scope, when a child is subject to a full care order, for local authorities to exercise discretion about whether or not the parent is in a position to give consent in the best interests of the child. Thus, on the recommendation of the TSC, we moved to asking local authorities to verify, case by case, which parents should be notified about the study before seeking their consent (both at the screening stage and at the baseline stage).

Process observations: working with children

• In this young cohort (i.e. aged ≤ 6 years) placements are often short term and there is some unpredictability in terms of the duration of placements. A key question we needed to consider was when a child should be considered eligible for the study, which involves a minimum 4-month intervention, when the likely duration of placement is difficult to predict. Through discussions with social workers and direct experience through the case series, we concluded that the best approach is to contact as many foster carers as possible at the screening stage (i.e. not limit screening based on expected placement length initially) and to have discussions on a case-by-case basis regarding potential progression to the intervention stage. Maintaining ongoing communication with those cases for whom there was uncertainty about placement length was important (e.g. if a final hearing was scheduled during the early phases of engagement or screening). Allowing flexibility and individualised decision-making would be beneficial for a future study, given that such cases are unlikely to be rare.

• Research assessments: we found, albeit in a small set of cases, that the children were happy to come to the study visits and do the assessments. It was also clear that it was important to keep the visits relatively short, as children could become impatient or tired after a while, particularly when they were not involved directly (i.e. when the carer was being interviewed).

• When the carer needs to bring siblings along to the study visit, it is crucial to have at least a second member of the research team to help.

Aims of the current study

This chapter presents the results of a scoping study using qualitative methodology to understand the impact, acceptability and feasibility of implementing a trial of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline, Foster Care (VIPP-FC) in a CAMHS and local authority context. To understand the facilitators of and barriers to the implementation of the VIPP-FC, the current study adopts a qualitative approach to exploring stakeholders’ experiences of and views on the general and specific research challenges posed by a clinical trial of an attachment intervention for young children in foster care. The primary aims were to further our understanding of the intervention–setting fit, the perceived usefulness and effectiveness of the intervention for this population, the facilitators of and barriers to implementation specific to local authorities’ children services and to identify stakeholders’ main concerns and key areas for future study development. 62 The qualitative data gathered from stakeholders can then be utilised to establish optimal systems and procedures for a future trial of the VIPP-FC.

This study ran in parallel with and after the case series, so that the participating stakeholders had acquired experience of the intervention (including training), the recruitment process and the challenges involved in preparing the partner sites to take part in the RCT. The majority of stakeholders involved in this initial phase (qualitative work) were selected from the research site participating in the case series project, as they had already experienced all phases of the research process, from initial engagement, planning, recruitment, obtaining consent and screening to treatment delivery. To maximise learning from this process and to gain the perspectives of other sites not involved in the case series, we also interviewed a small number of stakeholders during the early set-up phases of the feasibility RCT, whose input is also incorporated into this report.

Participants

Stakeholders involved in the early phases of the organisation and implementation of the VIPP-FC were invited to take part in the study. In total, 26 stakeholders were contacted. Of the 26 invited to interview, 15 responded and 13 agreed to be interviewed. One dropped out because of poor health, another had left their post and one had yet to begin work on the project locally as a result of delays in site set-up. Consequently, 10 stakeholders were interviewed.

Participants comprised six children’s social workers, three of whom were either service managers or deputy managers; two clinical psychologists, both of whom were service leads; one local authority commissioner; and one CAMHS practitioner. One participant worked in a CAMHS service, four worked in specialist adoption and fostering CAMHS teams, and the remaining participants were employed by local authorities. In terms of their roles in the VIPP-FC study, three participants held a strategic role (i.e. involvement in study design), five participants were involved in service delivery (i.e. offering the VIPP-FC in their service or being a trained VIPP-FC practitioner) and two participants were involved in both aspects. Two male participants and eight female participants were interviewed, with clinical experience ranging from approximately 3–20 years.

Procedure

To gather information on the facilitators and barriers that may affect the acceptability and feasibility of the intervention, stakeholders who were involved in the set-up and delivery of the VIPP-FC study in local authorities and CAMHS were invited to be interviewed. Participants who expressed initial interest were then contacted by a researcher and sent information about the study, as well as consent forms. Two of the interviews were carried out by telephone because of a lack of availability for face-to-face meetings.

Interviews

A semistructured interview schedule was developed based on Smith’s63 established guidelines. As the research involved stakeholders from various roles and professional backgrounds, four different interview schedules were drafted to suit these different positions held by the stakeholders in the study. The interview schedules addressed four general themes: (1) engagement of participants in the study, (2) supervision and training, (3) obstacles to and challenges of implementation and (4) acceptability of the VIPP-FC. The interview schedules were applied flexibly and the order in which these topics were explored was dependent on the material the participants brought. This helped to ensure that the interview flowed naturally and that spontaneous information could emerge. 64 Throughout the interview, participants were encouraged to elaborate on their answers by giving specific examples. The interviews lasted 50–70 minutes and were audio-recorded. Participants were invited to add additional comments or discuss topics that the interview schedule may not have captured at the end of the interview.

Qualitative analysis

Thematic analysis was applied to the interview transcriptions to understand the key patterns arising from the data. This approach was deemed suitable for the research objectives as it allowed the researcher to capture both similarities and differences among participants’ perspectives. 64 The process followed the general protocol outlined by Braun and Clarke;65 there were five phases of the analysis. NVivo 12 (QSR International, Warrington, UK) was used for data management. In the first phase, the qualitative researcher began by reading through the transcripts and familiarising themselves with their content. Once transcripts had been read through in their entirety, the researcher read the transcripts in a more active manner, taking notes of ideas, phrases or topics of interest. Phase 2 involved the initial generation of thematic codes. This involved the researcher working systematically through the transcripts, semantically identifying different features of the data. 65 The researcher also took note of data that did not fit the more common narratives during this process. Following this, in phase three, the researcher analysed these codes to consider how they could be combined to form broader themes and how they might be organised hierarchically. In phase four, each of the extracts that were coded for a theme were reviewed and examined to identify an overarching, coherent thematic framework. Themes were refined and divided into subthemes or merged together to form a larger theme. Once completed, these themes were then placed in the context of the entire data set to examine whether or not they reflect the meanings that were evident in the data. 65 The fifth phase involved the researcher trying to capture the essence of each theme and its application to the original narratives. This involved a final examination of each transcript to allow for theme refinement and ensuring that all nuances, contradictions and exceptions had been captured.

Credibility checks

Although thematic analysis includes some intrinsic quality-verifying procedures (e.g. checking of themes against coded data, the reviewing of themes against the entire data set), the qualitative researcher also undertook several credibility checks following good-practice guidelines developed by Barker and Pistrang,66 as well as those set forth by Elliot et al. ,67 to enhance the quality and validity of their analysis and subsequent conclusions. 65

In the initial stages of analysis, the researcher involved a second qualitative researcher and provided them with two transcripts to code. They then checked their coding of the two interviews against those coded by the second researcher to identify overstatements, discrepancies and potential errors. 67 Following this, a consensus approach was adopted to the development of the thematic framework. The researcher also involved a third member of the research team to review a selection of the data, compare ideas and discuss the best ways to represent the data.

Overarching theme 1: challenges of implementation

Box 1 presents the theme and subthemes of ‘challenges of implementation’. Throughout the interview process, participants reflected on the barriers to implementing the study, both from their direct experience of having been involved in the early stages of the project and their wider knowledge of the system. It was evident that there were three main areas that posed challenges: ‘chaos in the system’, ‘conducting a RCT in a local authority context’ and ‘elements of the VIPP-FC’. These subthemes operated on varying levels from a more macro systems, cultural level, to specific aspects of the intervention itself.

Overarching theme 2: benefits and impact of the VIPP-FC

Box 2 presents the theme and subthemes of ‘benefits and impact of the VIPP-FC’. The likely benefits and impact of being involved in the VIPP-FC study were separated into three distinct subthemes, each relating to a different layer within the ecological system. 68 The first, ‘creating an evidence base’, explores the wider system-level benefits that the study could have for developing the evidence base for support for children in foster care. The second relates to service-level benefits for engaging in the research and the impact the study could have on the practices of services. Finally, participants highlighted the potential positive benefits for the child and for the wider caregiving system around the child.

Overarching theme 3: key learnings

Box 3 presents the theme and subthemes of ‘key learnings’. This overarching theme consisted of two main subthemes: ‘importance of relationships’ and ‘recruitment fundamentals’. The latter comprised three subthemes, which addressed barriers to and facilitators of the recruitment process.

Setting

The study was a multisite RCT involving eight NHS trusts and nine linked local authorities, and took place across four large and distinctive regions in England: Greater London (North, South, East and West), Hertfordshire, Peterborough, and the Yorkshire and Humber region. As noted previously, a substantial number of local authorities was necessary to ensure adequate recruitment and to capture important variability in organisational contexts that may be important to understand when preparing a future larger-scale clinical trial.

Recruitment

Participants were identified initially through a large community screening process in the nine local authorities, with a view to identifying ‘at source’ (rather than through referrals or CAMHS; however, these were also accepted as a recruitment route) children experiencing high levels of behavioural signs of RAD on the screening questionnaires. Positively screened cases were assessed using the DAI to establish, using a validated and rigorous investigator-led diagnostic schedule, whether or not children showed evidence of RAD. Serious challenges to recruitment mid-way through the study led to a decision, supported by the TSC and funder, to remove the RAD eligibility criterion so that there was greater opportunity to run a reasonable number of cases through the research and intervention protocol. The decision to remove the RAD eligibility criterion also reflected a view shared by the research team and TSC that children in foster care are at substantially heightened risk of not only RAD, but a range of attachment difficulties and behavioural and emotional problems, and may therefore benefit, as a group, from the VIPP-FC. The outcome measures continued to track impact on RAD symptoms as well as these other clinical domains. The number of participants and their characteristics are described in Results, as they represent important feasibility-related outcomes.

Changes to protocol between the case series and the pilot randomised controlled trial

For the most part, the research protocol proceeded smoothly during the case series, so no changes were made to the assessment battery. The primary challenges were the somewhat lower than hoped for return rates of the screening questionnaires and the modest numbers of cases meeting criteria for RAD on the DAI. A key challenge was the lack of capacity within the local authority to undertake follow-up telephone calls to foster carers to encourage return of the screening instruments. In response to this, and in discussion with the TSC, we revised the protocol to allow members of the social work team to obtain verbal consent from foster carers for the research team to contact them directly by telephone. In consultation with our foster carer advisory group, we also substantially revised the study leaflets and information sheets to make them clearer and more appealing. We also introduced an alternative online screening/agreement to be contacted form following recommendations from our foster carer study member and advisory group. The study team received e-mail notifications from the study database when a participant gave consent and completed questionnaires online. Both the paper and online consent forms required the carer to provide their contact details (including the child’s initials) so that the research team could contact them to thank them and invite them to the interview stage. As these changes generally did not affect the overall research protocol, the methods are presented succinctly here; see Chapter 3 for detailed information about the research instruments.

Consent

No changes were made to the consent process from that used in the case series. During screening, active consent was required from the foster carer only. Passive consent was obtained from parents. After screening, if the child met the eligibility criteria to take part in the trial, full written consent was obtained from all those holding parental responsibility and from the foster carer, as well as assent from the child.

Measures

No changes were made to the assessment battery between the case series and pilot trial. The assessments consisted of the following:

• screening – the DAWBA Relationships with Adults scale, the ASA and the DAI

• baseline and post treatment – the Strange Situation Procedure, the DAWBA (full instrument), the CBCL, the Parenting Stress Index and the Parental Self-efficacy Scale, the CA-SUS and a carer–child interaction task (for coding of parental sensitivity with the NICHD scales).

Process data and qualitative outcomes

Process data were collected during the pilot RCT to document the uptake, numbers completing treatment, rate and stage of dropout, and acceptability of the treatment to participating families. Records were kept of the number of families approached that refused to take part in the study; data were also obtained on the range of care pathways observed (for example distribution of care orders and placement types, e.g. family and friends care, long-term foster care), the numbers moving placements before or after treatment commenced, and the destinations and timing of any movements out of placement. Records were also kept of essential information on a child’s previous history, such as number and type of previous placements. These data were obtained from a child’s social worker and/or foster carer. Reasons for refusing to take part in the study and for dropping out were also recorded.

The acceptability data gathered through the conduct of qualitative in-depth interviews with all consenting families that received the intervention as part of the pilot RCT.

Randomisation

Participants were individually randomised in a 1 : 1 ratio to one of the two treatment arms: the VIPP-FC plus CAU or CAU only. Randomisation with minimisation was employed, with minimisation factors age (≤ 4 vs. > 4 years), sex and site. Minimisation included a random factor, as implemented in the minimisation program SiMin. 70 Randomisation was requested by the research assistant using a standardised form following completion of all necessary screening and consent procedures, and was performed by an unblinded member of the trial co-ordination team. The allocation list was held in the Trial Master File. A member of the trial co-ordination team contacted the child’s social worker and VIPP-FC intervener (the latter for those allocated to VIPP-FC). The foster carer and the individual(s) giving consent on behalf of the child (the parent and/or local authority social worker with parental responsibility, as appropriate, see Chapter 5, Consent) were notified of the outcome by letter/e-mail by the unblinded member of the trial co-ordination team. The foster carer was also contacted by telephone to ensure a timely initiation of the intervention.

Blinding

All outcome assessments were performed by research assistants blind to trial arm allocation. All data handling and communication regarding unblinded information was undertaken by the Trial Co-ordinating Team. Prior to all research visits, the trial co-ordinator briefed the foster carer(s) about the importance of assessor blindness and any cases of inadvertent unblinding were recorded by the research assistant(s). By definition, foster families were not blind to the treatment arm to which they had been randomised.

Intervention

Sample size considerations

The planned sample size of 40 participants (20 per arm) was based on common recommendations for feasibility studies, in which the aim is to test practical implementation parameters, rather than to test treatment effects. Using data obtained from the Department for Education from 201471 (which we have corroborated against a selection of figures obtained in 201671 from our participating local authorities), we expected the full population of children in foster care in our target age groups across our sites to be in the region of 700. Previous screening work with this population led us to aim for 70–80% of foster carers to return the initial screening questionnaires; on that basis, and bearing in mind cost implications, we aimed for a sample size for the screening stage of 500 participants. To identify cases likely to present RAD, we planned to choose cases above the highest 66th percentile for symptoms of RAD, leading to a sample size of 150 who would be invited to take part in the more in-depth assessment of RAD symptoms using the DAI. Based on the previous RCT of the Fostering Changes programme,72 we expected two-thirds of those to agree to take part and complete the assessment. From this pool of 100 children, we expected to have scope to identify the target 40 cases who would be eligible for treatment, as long as the prevalence of RAD in the high-scoring screened group was ≥ 50% (allowing for a further 10% dropout at this stage).

It is important to note that, at the planning stage of this study, two key pieces of information were subject to considerable uncertainty. First, although clinical screening work within routine services locally were able to obtain 70–80% return rates, these were not obtained in the context of a research trial and had not been tested in all sites. In the case series, we obtained a screening questionnaire return rate of 60% (based on 20 cases), which, although lower, was not drastically out of line with expectations. However, this was from a single site only. Second, we lacked reliable information concerning the prevalence of RAD in UK foster care; thus, the 50% prevalence within the population of children exceeding the symptom threshold was subject to considerable uncertainty. Consequently, we planned for an interim analysis after 15 cases had been assessed to establish whether or not the proportion of RAD cases was below this expected proportion. The lower bound of the 95% confidence interval (CI) around a proportion of 0.50 is 0.22 with a sample size of 15. Thus, identification of fewer than three cases out of 15 would suggest that the prevalence was lower than 0.50. In this event, we planned to widen the eligibility criteria to include children not meeting full RAD diagnostic criteria, subject to approval from the TSC.

A sample size of 40 participants provides a reasonable balance between precision and cost. Assuming that the proportion of participants successfully completing the key outcome assessment is 75%, this yields a 95% CI of 59% to 87%. The consent/uptake rates could be estimated at two stages: for consent to take part in the eligibility assessment, and, following eligibility, the proportion entering treatment/being randomised. The former rates would be estimated with higher precision as they are based on larger samples. Assuming 67% (100/150) of participants take part in the eligibility assessment, this yields a 95% CI of 59% to 74%. Similarly, assuming that 80% of cases identified with RAD (40/50 participants) go on to be randomised, we would obtain CIs around that proportion of 66% to 90%.

Data analysis

Point estimates and 95% CIs were calculated for the key feasibility parameters based on proportions (proportions of cases identified, consented, randomised, completing treatment and completing outcome measures). Approximate variance estimates were obtained for the main outcome measures using the upper 80th percentile of the relevant CI. Specifically, we tested the following feasibility parameters:

1. Test the feasibility of identifying sufficient numbers of appropriate cases using screening instruments.

   • Target n for screening tests returned, n = 500. Test a.1 = proportion and 95% CI of those returning screening instruments from total sent out.

   • Target n of diagnostic assessments, n = 100. Test a.2 = proportion and 95% CI of positively screened cases (above upper 66th percentile) agreeing to full assessment.

   • Target n for positive diagnosis from upper 66th percentile of screened cases, n = 50. Test a.3 = proportion and 95% CI of cases for whom diagnosis is confirmed.

   • Test a.4 – initial test of false negative rate = proportion (of 25 cases) and 95% CI of detected diagnoses in random sample of cases not meeting screening threshold.

   • Test a.5 – initial non-parametric receiver operating characteristic (ROC) curve analysis (target n = 125), based on assumption that the DAI diagnosis is gold standard.

2. Test the feasibility of recruiting/consenting foster families with children with RAD to a RCT.

   • Target n of consented cases, n = 40. Test b.1 = proportion and 95% CI of cases consenting to enter pilot trial from those meeting entry criteria.

3. Investigate feasibility of randomising to the VIPP-FC or CAU.

   • Test c.1 – proportion and 95% CI of cases accepting randomisation.

4. Document study throughput.

   • Test d.1 – proportion and 95% CI of cases who are randomised completing treatment (definition of completing = 80% of offered sessions).

   • Test d.2 – proportion of cases attending each session (six proportions and 95% CIs).

   • Acceptability of treatment – qualitative methods for client experience of treatment interviews (see Chapter 7).

5. Establish the feasibility and acceptability of baseline and outcome assessments.

   • Test e.1 – proportion and 95% CI of cases with complete data. See also qualitative methods for client feedback regarding measures.

6. Identify the most appropriate primary outcome. Key assessment was participant feedback from qualitative interviews. However, preliminary tests from tests a.3, a.4 and a.5, were also considered.

7. Obtain initial estimates of variance of key outcome measures for future power analyses. Test – standard deviation (SD) of RAD symptom counts and 95% CI.

8. Establish the optimal and most acceptable screening tools for RAD, as recently redefined in the DSM-5. Tested with qualitative interviews and tests a.4 and a.5.

Recruitment sites and flow

The pilot RCT commenced in February 2018; recruitment ended in September 2019. All follow-up assessments were completed by the end of January 2020. Recruitment was attempted from a total of nine local authority children’s services and eight linked NHS trusts. The first site to open to recruitment was the site that took part in the case series. The second site opened in January 2018 and the remaining sites opened throughout 2018 and 2019, with the last site opening in April 2019. The first participant was recruited to the screening stage of the study in May 2018 and the first participant was recruited to the second-stage RCT in July 2018. Owing to serious challenges with recruitment and some delays in site initiations, recruitment was extended from the originally planned period of 12 months to 17 months.

Of the nine sites, we were able to recruit successfully from seven. Even with considerable effort, we were not able to progress with two London local authorities, despite their initial agreement and support. Throughout the recruitment period, we implemented several adjustments to the protocol to aid recruitment (see Chapter 1, Ethics amendments and protocol modifications and Appendix 1). The key changes that were implemented during the RCT period included the inclusion of additional sites and the dropping of the RAD-related eligibility criterion in March 2019. We illustrate the timeline and key events against progress on recruitment in Figure 2.

FIGURE 2.

Recruitment rate over time. Reproduced with permission from Oliveira et al. 73 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original figure.

Reproduced with permission from Oliveira et al. 73 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original figure.

Recruitment flow increased substantially in the last period of the study, as can be seen in Figure 2. It is not possible to precisely determine the reasons for the improved recruitment rates, but the improved rates largely coincided with the removal of the RAD criterion, the addition of three new and engaged sites (notably, all of which were outside London), and our success in one site in obtaining an honorary contract for a member of the research team to work within the local authority children’s services to directly support recruitment. The rate of recruitment in this final phase was four cases per month. Most of the other sites were unable to maintain their recruitment efforts in the final stages of the study. Therefore, this final phase primarily reflected recruitment from four sites. By the end of the recruitment period, we were able to recruit and randomise 30 cases to the trial, which was 10 cases below the original target.

Screening response rates and recruitment

The screening process involved close collaboration with partner local authorities, which sent out information sheets, initial consent forms and screening measures to the foster carers in the study localities. In addition, local authorities sent out a letter to all parents explaining the study and the opting-out process, and the letter included the contact details of the research team. They all communicated to their staff members within the children’s social care teams to raise awareness of the study and draw attention to the support required from children’s social workers. For this screening phase, we aimed to invite all foster carers or special guardians registered with the local authority caring for children aged ≤ 6 years. In practice, different local authorities applied their own exclusion criteria at this point (e.g. excluding highly complex cases undergoing assessments for court or cases with restricted files), as we note in Discussion.

The overall response and retention rates are shown as a CONSORT flow diagram in Figure 3. As is evident from the figure, the overall response rate to the screening questionnaire was 29% (95% CI 24% to 34%), which is substantially below the original target of 80% and below the rate achieved in the case series (60%). Specifically, of the 336 foster carers invited to complete the screening, 96 returned completed questionnaires. The overall number of mailed-out questionnaires was also smaller than the original target (n = 500), largely due to significant numbers of children registered with the local authorities being considered inappropriate or ineligible for the study (e.g. very short placements, placed out of borough). It is important to note that the return rate varied substantially per site, ranging from 3% to 63% (median 30%).

FIGURE 3.

The CONSORT flow diagram for the VIPP-FC pilot trial. LA, local authority. Reproduced with permission from Oliveira et al. 73 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original figure.

Reproduced with permission from Oliveira et al. 73 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original figure.

Approximate prevalence of reactive attachment disorder

The results of the DAI indicated an approximate prevalence of significant RAD symptoms in this sample of 33% (22/67 children assessed, 95% CI 22% to 44%). This proportion is based on cases scoring ≥ 3 points on the total RAD score, which indicates clinically significant difficulties (Charles Zeanah, Tulane University, 2015, personal communication). Furthermore, 41 out of the 67 foster carers’ DAIs received a score of at least 1 point (scores can range from 0 to 2 points for each item) on at least one RAD item, and of these participants, 33 received a total RAD score of ≥ 2 points (51%, 95% CI 37% to 61%). These can be seen as cases who show some difficulties in the areas of development tapped by the DAI-RAD items.

Participant characteristics

As demographic data were collected both at initial screening and at entry to the RCT, it is possible to compare the composition of the trial sample with that of the larger group of screened cases for indications of sampling bias. Table 1 shows the key demographic data for the larger and the smaller subsamples; as can be seen in the table, children and carers that took part in the trial (n = 30) did not appear to be different from the overall group of children who took part in the screening, except for legal status: a larger proportion of children on a full care orders were in the sample taking part in the trial. This is likely to be related to the fact that these children tend to remain in their current placement for longer and to the simpler consent process for these children, as their parents were not required to provide active written consent.

Timing of randomisation, baseline and follow-up assessments

The original study design aimed to allocate cases quickly after baseline assessments had been completed and ideally within 48 hours. The period between baseline and follow-up was expected to be approximately 4 months, which was the expected duration of the intervention. However, we expected this to be potentially quite variable in practice and so allowed the outcome assessments to be undertaken after treatment had ended for all cases in the treatment arm. To balance duration of follow-up across the arms of the trial and reduce the risk of unblinding, we trialled a procedure in which the follow-up period in the CAU arm was yoked to a case in the treatment arm. Matching was undertaken with a relatively wide window (up to 1 month) to not excessively constrain scheduling of follow-ups. The resulting timing of follow-ups is presented in Table 2.

As Table 2 indicates, in general, the time period between baseline and randomisation was comparatively short, but some delays occurred in a number of cases, with one very lengthy delay, which was due to a lack of availability of a VIPP-FC intervener in the relevant site. On average, the actual period between baseline and follow-up was 6.4 months. The duration of the follow-up period was relatively balanced between the two arms of the trial, although the small number of cases with long delays shifted the mean time period in the VIPP-FC arm to more than that of the CAU arm, despite the pairwise matching.

Evaluation of feasibility parameters

In this section, we summarise the data on the key feasibility questions we set out to address in the pilot trial, as detailed in Methods. Each question is presented in the order described in that section.

A. Feasibility of identifying sufficient numbers of appropriate cases using screening instruments

1. The proportion of screening questionnaires returned from the total sent out was 0.29 (95% CI 0.24 to 0.34).

2. The proportion of positively screened cases (above the upper 66th percentile) agreeing to full assessment on the DAI was 0.73 (95% CI 0.60 to 0.86). Scoring high on the screening questionnaires did not seem to make a significant difference to whether or not carers accepted the DAI. Specifically, the proportion of cases scoring below the 66th percentile on the screening questionnaires that agreed to participate in the DAI was 68%.

3. The proportion of cases scoring above the 66th percentile on either screening questionnaire that scored ≥ 3 points on the DAI was 0.86 (95% CI 0.71 to 1.0). The proportion of cases scoring ≥ 2 points on the DAI (the less stringent threshold) that were above the 66th percentile on either questionnaire was 0.76 (95% CI 0.61 to 0.91).

   We conducted a more fine-grained analysis of the detection rates for each questionnaire. Of the cases confirmed as presenting a RAD score on the DAI of ≥ 3 points, 77% were detected by the DAWBA alone and 68% were detected by the ASA alone, with each case again using the 66th percentile threshold.

4. The false-negative rate, that is the proportion of cases with a DAI RAD score of ≥ 3 points but not meeting the screening threshold on either questionnaire, was 0.09 (95% CI 0.00 to 0.21). If we use the less stringent DAI RAD threshold, the false-negative rate was 0.24 (95% CI 0.09 to 0.39).

   Considering each questionnaire separately, the false-negative rate (based on the 66th percentile threshold) was 0.23 for the DAWBA and 0.32 for the ASA. Using the less stringent DAI criterion, the corresponding rates were 0.36 and 0.45.

5. Initial non-parametric ROC curve analysis was undertaken based on the assumption that DAI diagnosis is gold standard. We used non-parametric ROC curve analysis to investigate the overall performance of the two screening questionnaires against the DAI. Considering the DAWBA first, non-parametric ROC analysis estimated an area under the curve (AUC) of 0.84 (95% CI 0.74 to 0.92). The ROC curve is shown in Figure 4a. In general, the DAWBA showed good sensitivity, with a raw score threshold of ≥ 2 points, yielding an estimated sensitivity of 0.96 and specificity of 0.48. At this cut-off point, the positive predictive value was 49% (95% CI 35% to 63%), the negative predictive value was 96% (95% CI 77% to 99%), the positive likelihood ratio was 1.74 (95% CI 1.33 to 2.27) and the negative likelihood ratio was 0.09 (95% CI 0.01 to 0.60). A threshold of ≥ 3 points (which is the 66th percentile in our sample) yielded a sensitivity of 0.77 and a specificity of 0.80. With a cut-off point of 3 points, the positive predictive value was 63% (95% CI 44% to 79%), the negative predictive value was 85% (95% CI 71% to 94%), the positive likelihood ratio was 3.01 (95% CI 1.77 to 5.13) and the negative likelihood ratio was 0.31 (95% CI 0.15 to 0.64). Depending on the objectives and, therefore, the preferred balance of false negatives and false positives, a threshold score of 2 or 3 points would seem appropriate using this instrument.

   The ASA scored similarly well, with an estimated AUC of 0.83 (95% CI 0.71 to 0.91). The ROC curve is shown in Figure 4b. Inspection of the graph suggests that after (1 – specificity) rises to around 0.26–0.30, improvements in performance level off. A threshold score on the ASA of ≥ 24 points yields an estimated sensitivity of 0.74 and specificity of 0.78. For this cut-off point, the positive predictive value was 57% (95% CI 39% to 74%), the negative predictive value was 84% (95% CI 68% to 94%), the positive likelihood ratio was 2.41 (95% CI 1.51 to 3.85) and the negative likelihood ratio was 0.34 (95% CI 0.16 to 0.70). A lower threshold of ≥ 21 points yields sensitivity of 0.91 and specificity of 0.66. A cut-off point of 21 points yielded a positive predictive value of 55% (95% CI 39% to 70%), a negative predictive value of 93% (95% CI 77% to 99%), a positive likelihood ratio of 2.17 (95% CI 1.53 to 3.08) and a negative likelihood ratio of 0.13 (95% CI 0.03 to 0.52). In our sample, a score of 21 points reflects the 51st percentile, which is considerably lower than our original screening cut-off point. Overall, there is indication in these data that the ASA may be marginally superior to the DAWBA for identifying cases, possibly reflecting its greater variability. Across all cases in the study, the DAWBA yielded 10 different recorded scores (reflecting the number of items), whereas the ASA showed a considerably wider range of scores (26 different values, 12–47 points).

6. Combining and standardising both questionnaires yielded an estimate of the AUC of 0.87 (95% CI 0.78 to 0.94). The ROC curve is shown in Figure 4c. An averaged z-score on this composite measure of –0.036 (close to the sample mean) yielded a sensitivity of 0.92 and a specificity of 0.78. For this cut-off point, the positive predictive value was 66% (95% CI 47% to 81%), the negative predictive value was 88% (95% CI 74% to 96%), the positive likelihood ratio was 3.45 (95% CI 1.99 to 5.98) and the negative likelihood ratio was 0.25 (95% CI 0.11 to 0.56). A z-score of –0.26 gave a sensitivity of 0.96, while retaining a comparatively good specificity of 0.65. In this case, the positive predictive value was 60% (95% CI 43% to 74%), the negative predictive value was 97% (95% CI 83% to 99%), the positive likelihood ratio was 2.66 (95% CI 1.80 to 3.92) and the negative likelihood ratio was 0.06 (95% CI 0.01 to 0.42). These results suggest that combining the DAWBA with the ASA is preferable if time and considerations of burden allow for this. Consistent with that inference, a logistic regression, based on z-standardised scores, showed that both the DAWBA and the ASA RAD scales independently contributed to the prediction of RAD diagnosis based on the DAI (DAWBA odds ratio 5.0; p = 0.003; ASA odds ratio 3.6; p = 0.004).

FIGURE 4.

The ROC curves for screening questionnaires against the DAI, with 95% CIs. (a) DAWBA; (b) ASA; and (c) DAWBA and ASA combined.

Adverse and significant events

No adverse events were recorded during the course of the trial, but substantial numbers of significant events were noted. The significant events recording was designed to capture pertinent changes in a child’s health and circumstances tailored for children in foster care. At baseline, foster carers were asked whether or not any significant events had occurred to the child in terms of their health, their schooling (if applicable), their care order or contact arrangements (Table 5 shows all of the categories). In general, the most common significant events were changes in foster placement, contact arrangements with parents, schooling and care order. Table 5 shows the number of individual events recorded for each category for the two arms of the trial.

We did not plan any statistical analysis of the significant events data. Nevertheless, we note that there was indication of possible differences in the rates of significant events between the two arms of the trial at follow-up, which was not apparent at baseline. The mean number of events at baseline was 0.73 for both groups (VIPP-FC, SD 1.02; CAU, SD 0.96). At follow-up, the mean number of events was 0.61 (SD 1.12) for the VIPP-FC group and 1.5 (SD 1.25) for the CAU group. The mean difference at follow-up adjusted for baseline was 0.95 (95% CI 0.04 to 1.9). The apparent difference in rates largely concerns significant events linked to changes in the placement and care order, with fewer of these events reported for the children receiving the VIPP-FC. It is not possible to determine in all cases whether or not these were planned changes, or, indeed, whether they are positive or negative outcomes. Nevertheless, given the negative impact of placement instability, the smaller number of placement-related changes in the VIPP-FC group is quite notable, if very tentative, given the small number of cases involved.

Description of care as usual

One aim of this feasibility study was to find out which services are typically used by the target population. Given that difficulties in the realm of attachment problems in this younger cohort of looked-after children are often not assessed or treated, we anticipated that most children would not be receiving targeted psychological therapeutic interventions. On the other hand, emotional–behavioural difficulties often result in children and their families being offered other support services; therefore, it was important to take a broad perspective when asking about service usage to capture any kind of health, educational and community service (see Chapter 6 for a detailed analysis of all these types of services). In addition, given the multilevel difficulties often associated with being looked after, as well as the complex system involved in caring for these children, we expected that they would be involved with a large number of services and professionals.

The findings were in line with these expectations. We report details of the services that the whole group of 30 children were reported to use during the 4 weeks prior to being interviewed. Carers reported that children were seen by a general practitioner (GP) (n = 3 at surgery and n = 1 by telephone consultation); a nurse at the surgery (n = 2); a health visitor, district nurse or school nurse (n = 11); and a family partnership nurse (n = 1). A small number of children had been seen by a care co-ordinator or case manager (n = 2), and the same number had been seen by a family support worker (n = 2). The majority of children had seen their social worker in the previous 4 weeks (n = 22). Other related services that families had used were a foster support worker (n = 1) and an adoption social worker (n = 1). Seven children had received speech and language therapy in the previous 4 weeks. One child had been seen by a community paediatrician for their health and care plan. In terms of psychological services accessed in the previous 4 weeks, a few children had seen an art/drama/music/occupational therapist (n = 3), and others had seen a CAMHS worker (n = 3), a counsellor (n = 2) or a clinical psychologist (n = 2).

New service types that children received between baseline and follow-up were (1) a psychiatrist, (2) a community psychiatric nurse, (3) an educational psychologist and (4) a play therapist.

Children aged ≤ 6 years in foster or kinship care clearly receive a diverse set of services related to their development and well-being. The services that are offered can include universal services related to being in care (e.g. social worker visits), services for children identified as requiring additional support (e.g. carer consultation or one-to-one support at school), or services offered for reasons other than being identified as requiring additional support; our aim was not to determine whether or not the services related specifically to RAD, but to describe which services participants were using and how frequently. This will be important information to consider when planning a larger trial, as it will allow careful consideration of the comparator arm.

Intervention delivery process

Prior to conducting baseline assessments, a careful process of capacity-checking had to take place, considering participants’ and interveners’ locations and availability, so that, as far as possible, if a case was randomised to the VIPP-FC an intervener would be available to take on the case. As we had only one or two interveners in any one locality, small runs of cases randomised to the VIPP-FC or changes in staff availability (e.g. when staff move jobs) could lead to an inability to allocate or to lengthy delays. In the following sections, we summarise observations of the process of intervener training, the allocation process and the treatment delivery itself.

Process observations regarding intervention delivery

The modifications introduced to the manual and delivery of the programme, including shortening the gaps between sessions, were received well. We received positive feedback from both interveners and foster carers about the programme overall. We also collected feedback about the VIPP-FC from the interveners’ logbooks, which they completed after every session. The key points that interveners noted were as follows:

• Foster carers enjoyed watching the videos and engaged with them.

• The programme helped them to notice, interpret and react to behaviours and signals of their child that they had not seen before.

• The programme helped carers notice changes and improvements in the child’s behaviour over time that they would not otherwise have noticed.

• The programme enabled carers to recognise how they can more sensitively respond to the child.

• It helped carers to see how strong their bond was with their child.

See Chapter 7 for the detailed impressions of foster carers.

The main challenges with the delivery of the intervention were the changing capacity of interveners, the small numbers of interveners in any one site (despite the large number overall) and, relatedly, difficulties in matching incoming cases to interveners’ locations and availability. This meant that, in addition to one child not being allocated to the intervention, six interveners whom we had trained were not allocated to any cases.

Challenges to clinical process

One common problem to emerge was that, because we were working with older children (up to aged 7 years) than is usually the case with the VIPP-SD, the older children often listened to the instructions the intervener was giving or to the feedback; this meant that interveners had to be sensitive to the wording and language used in front of the child. Accordingly, a recommendation for the future is that it would be ideal to plan for older children not to be present for the delivery of feedback. Another recommendation is to plan to have someone present to look after the other children at home when watching the clips. Sometimes foster carers said that the other foster child(ren) might be distressed by the target child having the programme and them not, or they would require their attention too much throughout the visit.

Relatedly, a frequent experience of interveners was a greater need to think ‘on their feet’ as the children could be particularly challenging and the carer was sometimes very busy/distracted by what else was going on for the child that day, or by other children, both when filming and during the feedback. It also became apparent how important it was for interveners to fully understand the stress that a lot of foster carers are under and the types of concerns they have. An issue raised by some interveners was that foster carers noted that some VIPP-FC tips can appear to contradict advice given by social workers, for example about whether or not to use physical touch with the child. In future, this could be incorporated into the intervener training so that they are more prepared to handle this sort of situation.

An important issue that emerged in this study related to the fact that some interveners had a dual role, both study intervener and holding another position within the local authority or CAMHS. It was reported to be difficult for some interveners to keep their VIPP-FC role separate from their main role, especially if the case was also being seen by their team independently of the VIPP-FC work. For example, sometimes the carers wanted to talk about non-VIPP-related issues, such as network meetings, in the visits, which then led to much longer visits. This also raises the question of who is best placed to deliver the VIPP-FC with this population. For a future trial, the advantages and disadvantages of different models of delivery need to be considered. Some advantages and disadvantages of having the VIPP-FC embedded in CAMHS, rather than delivered by, for example, external trial therapists, were noted.

Methods

The CA-SUS is a service use schedule that was developed originally for use in economic evaluations of mental health services for children and adolescents. It is generally completed in interview with parents, although it can be completed in interview with older children (i.e. adolescent populations). The CA-SUS is a retrospective measure that asks respondents to report use of various services over a specific period, for example over the previous 3 months. The CA-SUS contains a number of sections that can be included or excluded dependent on the economic perspective of the study, for example hospital services, community health and social care services, medication, accommodation and education.

The CA-SUS has been successfully applied in a number of populations similar to the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline, Foster Care (VIPP-FC) population, including looked-after populations and pre-school populations. 50,74,75 Because study participants, economic perspective, and duration and timing of follow-up vary by study, the CA-SUS must be adapted for the purpose of each new study. These earlier versions of the CA-SUS formed the basis of a modified version suitable for the current population,50,74,75 with modifications being determined, initially, by expertise in the research group and, subsequently, by testing the acceptability and comprehensiveness of the VIPP-FC CA-SUS in the feasibility study.

The VIPP-FC CA-SUS was administered in interview with foster carers during the baseline interview, covering service use over the previous 4 weeks, and at the 4-month follow-up, covering service use in the period between the baseline assessment and the follow-up interview date. The economic perspective was the NHS and social services perspective, preferred by NICE, plus education sector resources (support services provided in schools and education facilities attended), given the age of the population.

The initial draft version of the VIPP-FC CA-SUS was tested and modified in two ways. First, using feedback from research assessors who supported participants to complete the CA-SUS in interviews, we assessed research assessors’ and respondents’ understanding of the questions and modified the wording or added an explanation when anything was unclear. Second, we assessed the measure’s comprehensiveness in capturing all relevant services by identifying services used by young participants but not included in the draft CA-SUS (missing items), and any items included in the draft CA-SUS but not used by the young participants (redundant items). To assess missing items, research assessors probed for and recorded any services used by young participants that had not been covered during the course of the CA-SUS interview.

Amendments to the CA-SUS were made during the data collection period to provide an opportunity to test an improved version during the feasibility study and at the end of data collection. Initial amendments were made after 12 interviews had been completed (n = 9 at baseline and n = 3 at the 4-month follow-up) and involved discussions between the research assessors and CA-SUS designers to explore the findings so far. Research assessors highlighted any difficulties with clarity and any missing items that were being reported by a number of participants, and necessary adjustments were made. The new version of the CA-SUS was then used for all subsequent baseline and follow-up interviews. At the end of the study, all hard-copies of completed CA-SUS questionnaires (n = 58) and the CA-SUS data contained in the study database were checked for errors, redundant items (no recorded use), missing items (recorded under ‘any other service use’) and any additional feedback from research assessor notes on the hard copies of the CA-SUS.

Results

Feedback from research assessors suggested that the CA-SUS was easy to use, taking between 5 and 10 minutes to complete, and was acceptable to both interviewers and interviewees. Interviewers found that foster carers were able to answer all of the questions and there was no need to interview social workers to fill any gaps.

A summary of CA-SUS item completeness, including percentage of missing data (no response provided), redundant items (no use recorded) and missing items (additional service use recorded under ‘any other service use’) is provided in Table 6; for reference, the adjusted version of the CA-SUS is presented in Appendix 2. Some items contained in the CA-SUS are excluded from Table 6; these were not intended to be costed and included in the economic evaluation, but were of interest to the research group (e.g. statement of special education needs, days of school missed).

Overall, almost all of the questions in each section of the CA-SUS were completed appropriately and almost all of the questions contained a response; therefore, the issue of missing data was not identified as a problem, which suggests that participants were able to understand the questions and found them acceptable.

The accommodation section (A1) was 100% completed, with no implausible values. The only accommodation types reported were formal foster care, provided by local authorities or private agencies, and formal kinship care. All other accommodation types were reported as zero use (redundant items), including domestic accommodation with parents/adoptive parents, informal foster care including informal kinship care, residential care provided by a local authority or private agency, residential mother and baby facility, bed and breakfast, boarding house or hotel, refuge, supported housing and short break/respite care. No ‘other’ accommodation was reported; thus, there were no missing items.

Type of education (B1) was 100% completed, with no implausible values. No children received home tuition or were in residential schools (redundant items). Additional schooling types recorded under ‘other’ included portage (n = 2), special needs school (n = 2), speech and language therapy at school (n = 1), early risers (n = 1), breakfast club (n = 1), small support group (n = 1) and booster classes (n = 1). A number of responses appear to relate to school-based services, rather than education types, and thus can be excluded from this section (e.g. breakfast club, small support group, booster classes). However, it may be appropriate to consider them for inclusion in the community service section of the VIPP-FC CA-SUS, with some rewording. For example, ‘speech and language therapy at school’ can be classified alongside other community speech and language contacts. Most of the remaining responses lacked enough detail to determine what exactly was being reported and thus were ignored (e.g. early risers, small support group and booster classes). One service was reported that the team felt could potentially be relevant to the population (portage: a home-visiting educational service for pre-school children with special educational needs and disabilities), and thus should be added to the community services section of the VIPP-FC CA-SUS. The only responses focused on education types (e.g. education facilities) were for special needs schools; again, the team felt that this could potentially be relevant for this population and so should be added to a the VIPP-FC CA-SUS.

In terms of hospital services, use of inpatient, outpatient/day-patient and accident and emergency services (C1, C3 and C5; yes/no response required) was 100% completed. Number of inpatient nights, number of outpatient/day-patient appointments and details of any accident and emergency attendances were all 100% completed (C2, C4 and C6). However, a number of additional responses were recorded under ‘other’, where specialty was unknown (C2 and C4). These responses are used to help identify the appropriate specialty. Responses for inpatient specialty included bronchoscopy, magnetic resonance imaging and sleep study. Responses for outpatient/day-patient specialty included bronchoscopy, eye appointment, immunology, blood test, heart screen, sleep test, physiotherapy and genetic test.

The community services section (D1) was 100% completed, with zeros recorded to indicate no service use. No service use was recorded for GP home visits, GP telephone contact, family therapist, education welfare officer, advice service or helpline. Some feedback was received from research assessors. First, they suggest a need to distinguish between a child’s social worker and a foster carer’s supervising social worker. Second, they reported that item 19, ‘advice service’, did not seem to apply to this population, perhaps because foster carers instead turn to their supervising social worker. In terms of number of contacts with each service accessed, these sections were 100% complete. Average duration of contacts with community services, however, was missing for a number of services, including community psychiatric nurses (missing for one out of one contact reported), counsellors (missing for two out of three contacts reported), social worker (missing for 1/48 contacts reported), educational psychologists (missing for one out of one contact reported), speech and language therapist (missing for 4/15 contacts reported).

Additional community services reported under ‘other’ included physiotherapist (n = 2), community paediatrician (n = 1), personal education plan (n = 1), family partnership nurse (n = 1), adoption social worker (n = 1), play therapist (n = 1), community nurse (n = 1), foster support worker (n = 1), dietitian (n = 1), occupational therapist (n = 1) and audiologist (n = 1). Some of these services can be reclassified within the existing list of services. For example, ‘adoption social worker’ can be included under ‘social worker’. ‘Community nurse’ and ‘family partnership nurse’ are community nurses, and can be classified alongside ‘school/college nurse, health visitor, midwife or district nurse’, suggesting the need to reword this item to make clear that this should include all nurses working in the community. ‘Foster support worker’ could be classified alongside ‘family support worker’, again suggesting the need to reword this item to make clear that this should include any support workers. All but one of the remaining services were reported by only one respondent. However, categories emerged that could be useful to add, for example there were a range of different ‘therapists’ (physiotherapist, occupational therapist, play therapist) that may usefully be added to the VIPP-FC CA-SUS.

The medication section was 100% completed, with 15 out of 58 respondents reporting use of prescribed medication.

Conclusions and recommendations

Methods

The second aim involved exploration of recent literature to assess how realistic it might be to include a measure of HRQoL capable of generating QALYs in this young age group. QALYs are a generic, preference-based measure of HRQoL that are used in cost–utility analysis and allow comparison across different disorders for resource allocation purposes. Without such a measure, it is difficult to make clear resource allocation decisions through the application of the NICE threshold of £20,000–30,000 per QALY. However, when the VIPP-FC feasibility study was proposed, no validated measure existed for children aged ≤ 6 years and methodological guidance for alternative approaches was limited. We therefore proposed exploring any developments in the literature that occured during the course of the feasibility study that might provide better guidance.

We searched various databases and websites for guidance in very young children, including the NIHR website, the NICE website, clinical trial registries (ClinicalTrials.gov, the EU Clinical Trials Register) and websites for instruments known to be used to derive child health utilities in the UK. We contacted experts in child health utilities asking for their insights, any new evidence and if they were aware of any ongoing work developing or testing child health utility measures in children aged ≤ 6 years.

Results

Recruitment

All participants who received the VIPP-FC as part of the case series or feasibility RCT were eligible and were invited to take part in this study. Interviews were completed with 11 foster carers (nine from the RCT and two from the case series). Reasons for not interviewing eligible foster carers were as follows: two foster carers who were randomised to the VIPP-FC did not receive the intervention; in addition, one carer dropped out of the RCT prior to the intervention taking place, one child was moved before the VIPP-FC work started, one carer declined to be interviewed and we were unable to contact one foster carer.

Data collection

Interviews were conducted face to face in foster carers’ homes between January and March 2020. After addressing any questions and obtaining written consent, the interviews were audio-recorded. An interview schedule was developed in consultation with the study team and through discussion with and feedback from the study’s foster carer advisors. The interview focused on all stages of the trial process, from initial contact and screening to receiving the intervention and completing the research assessments.

Data analysis

The audio-recordings were transcribed verbatim and anonymised by a member of the research team. We adopted the same analytic approach as in the previous qualitative study, presented in Chapter 4. Thematic analysis is well suited to implementation research and provides a helpful framework for drawing out both similarities and differences among participants’ perspectives and conceptually organising emergent themes. 64 This involved the researcher working systematically through the transcripts, identifying notable features of the narratives and coding/labelling them using NVivo. 65 These lower-level codes were then combined to form broader themes and subthemes, and initial drafts of emergent overarching themes were teased out. The overarching themes and subthemes were then reviewed again in relation to their fit with the original narratives and were adjusted when necessary. 65

Theme 1: motivation for taking part in the study

Participants expressed a range of reasons for taking an interest in the study; indeed, many could not confidently enough to state precisely what had led them to agree in the first place. For some of them, this may have been partly related to the somewhat lengthy process between initial contact at the screening stage to completing the intervention and feedback interviews. Participants’ expectations of the VIPP-FC varied greatly, with some clearly hopeful about the difference it might make, for example to ‘try something new’ [participant (P) 3] and ‘gain knowledge’ (P8), whereas one felt that ‘[given my experience of] things that I had done with the children before, . . . I didn’t really hold out much hope if I’m going to be totally honest’ (P1). Foster carers’ motivation and expectations about receiving the VIPP-FC responses could be divided into three subthemes: to help research, to help the child or to learn new skills.

Theme 2: experience of the VIPP-FC intervention

In general, all participants spoke very positively of their experience of the VIPP-FC. There were three subthemes that articulated how the participants felt about their involvement in the intervention. These themes are practicalities, the relationship with the intervener and being video-recorded.

Theme 3: learnings from the VIPP-FC intervention

The theme that occupied the largest portion of the narratives revolved around the positive things that foster carers felt they had learned or gained from the VIPP-FC sessions. This theme could be divided into several subthemes: strategies, techniques and tips, learning about the children in my care, noticing things I would not have noticed before, and confirmation or confidence in what I am already doing.

Theme 4: future improvements

The foster carers who received the VIPP-FC as part of the study had a number of thoughts and suggestions for improvements to the project for a study. A number of the foster carers felt that the intervention should be more targeted to carers and children who need it the most. These reflected suggestions about targeting, timing and the need for local authorities to make training such as this part of routine support for foster carers and their foster children.