Background
Looked-after children are a very vulnerable group who are at greatly increased risk of experiencing mental health problems and poor long-term social, emotional and educational outcomes.1,2 Despite this, remarkably few interventions exist that have proven efficacy for intervening in the case of or preventing poor outcomes for these children.3 Accordingly, there is an urgent need to develop new and effective interventions to improve the outcomes of children in care. In particular, looked-after children are at a fivefold increased risk of all childhood mental, emotional and behavioural problems, and are six to seven times more likely to have conduct disorders. In adulthood, they are between four and five times more likely to self-harm.1
Critically, the number of children in care has risen steadily in the UK in recent years. Figures from the Department for Education show that, in 2019, the number of children looked after by local authorities in England increased by 4% since 2018, to 78,150.4 Although the number of children entering care during the year decreased by 2% (to 31,680), the number of children leaving care during the year also decreased 2% (to 29,460), suggesting that some children are spending longer in care. Children ceasing to be looked after during 2018–19 as a result of adoption, in particular, fell by 7% (to 3570), a continuing drop seen since 2015. On the other hand, children who ceased to be looked after as a result of a special guardianship order (SGO) increased by 11% to 3830. There has been a slight decrease in the proportion of looked-after children who are placed in foster care, but foster care remains the most common type of placement. In 2019, 72% of looked-after children were in foster care; the great majority were placed with a foster carer who was not a relative or friend.
Given the size and disproportionately at-risk nature of this group, and the level of responsibility borne by foster carers, there is great need for evidence-based foster carer-led interventions to support them in improving the short- and long-term outcomes of looked-after children.
The most common primary reason for children becoming looked after is abuse or neglect (63%), followed by family disfunction (14%); other parenting difficulties account for the majority of the remaining cases, with child factors (e.g. child disability) identified in a minority of cases as the primary reason.4 Thus, children who are looked after have typically been exposed to harmful experiences; abuse, neglect and major disruptions in parent–child bonds are prominent.5 Although these experiences almost certainly affect child development in a number of ways, one very well-documented and important area is in the development of attachment.6 Attachment is a critical early-appearing developmental phenomenon that is observable from the first year of life, in which children maintain proximity to and selectively seek comfort from their carers when they are worried, anxious or distressed, and attachment is thought to be critical for their optimal long-term development. Attachment is believed to be largely instinctive, but the way in which a child’s attachment behaviour is manifested or organised is dependent on the environment and, particularly, on the quality of care.7 A large body of research has demonstrated that suboptimal and disordered patterns of attachment behaviour can arise when children experience insensitive, frightening, neglectful or abusive care, or frequent change of carers.7,8 These early difficulties in attachment leave a child at risk of poor social and emotional outcomes.9,10 In contrast, a secure attachment, whereby a child is able to openly communicate their attachment needs and be readily comforted by contact, is consistently associated with better developmental outcomes across a range of areas7,9–12
Following an extensive review of the literature, a recent National Institute for Health and Care Excellence (NICE) guideline13 identified three clinically important forms of suboptimal attachment patterns that should be considered important targets for intervention among children in care. These patterns, referred to collectively as ‘attachment problems’ by the guideline group, are reactive attachment disorder (RAD), disinhibited social engagement disorder (DSED) and disorganised attachment. RAD and DSED are observed almost exclusively among children who have been subjected to extreme neglect and/or repeated changes in caregivers, whereas disorganised attachment may arise in the context of abuse, neglect or highly insensitive/atypical parenting.10
Reactive attachment disorder is considered an attachment disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition14 (DSM-5) (previously referred to as the RAD-inhibited subtype in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition), and refers to a pervasive absence of attachment behaviour by young children towards their carers, combined with highly withdrawn and fearful behaviour and emotional volatility. RAD is observed at relatively high rates among children raised in institutions (43% in Zeanah et al.5), but there is considerable uncertainty regarding its prevalence among children in UK foster care (Zeanah et al.5 reported 35% RAD in a US foster care sample).
Although DSED has traditionally been defined as an attachment disorder (previously referred to as RAD-disinhibited subtype), it has been reclassified as a disorder of social behaviour in the DSM-5. These children show a striking lack of reticence with strangers, are prone to engaging in inappropriately intimate social (including physical) contact with strangers, and may wander off with strangers. Despite this behaviour with strangers, they show attachment behaviour, sometimes even of the secure type, to their primary caregivers in standard separation–reunion procedures such as the Strange Situation Procedure.8 The evidence is quite clear that RAD and DSED are different disorders, showing distinct characteristics, aetiologies and courses.10 Although the precise relation between DSED and the attachment construct is controversial, it is generally accepted that it reflects a lack of selectivity in social approach, which is at least closely related to attachment.15
Disorganised attachment is observed in around 3–15% of normative populations, and it is much more prevalent among children raised in highly deprived circumstances or those exposed to abuse (48% of abused pre-schoolers are disorganised according to meta-analytic work; see van IJzendoorn et al.16). Disorganised attachment is also observed at elevated rates in children in foster care compared with controls (d = 0.41; see van den Dries et al.17). Disorganised attachment is not a disorder and is arguably more accurately described as a relational or developmental vulnerability factor that increases the likelihood of adjustment difficulties in the future.
A large number of intervention studies have shown that it is possible to increase the rate of secure attachment and reduce rates of disorganised attachment in a range of normative, at-risk and clinical populations by improving the sensitive responsiveness of parental care.13,18,19 Such interventions often combine a number of treatment elements, but share the common objective of helping parents to become sensitively attuned to a child’s attachment cues, and to respond to them consistently and appropriately.
Video-feedback techniques are a commonly used and effective strategy for helping parents to increase their sensitivity to attachment cues and video-feedback-based interventions reliably increase rates of secure attachment and reduce rates of disorganised attachment (d = 0.44, k = 5).19 Indeed, video-feedback interventions may be particularly helpful for high-risk children who have experienced significant disruptions in care. Three trials have used video-feedback interventions focused on improving caregiver sensitivity as a means of reducing attachment difficulties (specifically disorganised attachment) among children who had been adopted or maltreated, and all reported positive, significant and sizeable treatment effects (Bernard et al.:20 d = 0.72; Juffer et al.:21 d = 0.80; and Moss et al.:22 d = 0.90).
Two independent and wide-ranging reviews, one commissioned by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme19 and the other conducted by NICE,13 concluded that interventions promoting sensitivity had the best evidence of effectiveness for reducing attachment problems among children in care. The NICE guidance13 specifically recommended video-feedback methods because of their good clinical efficacy and cost-effectiveness profiles.
The Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD)23 is the most rigorously tested sensitivity-focused video-feedback intervention; it has repeatedly been shown to improve parental sensitivity to attachment cues (d = 0.47, k = 12)24 and has been used in a broad range of contexts and age ranges (up to the age of 5–6 years), making it an attractive choice for a brief and cost-effective treatment for children in foster care.
It is critical to note, however, that the HTA programme review19 also highlighted the fact that no study had yet tested whether or not any intervention can effectively treat RAD. Given the likely high prevalence of RAD in the foster care population, this is a serious research gap.8 It is also noteworthy that no studies have tested the effectiveness of the VIPP-SD for improving attachment security and reducing attachment problems in a UK health-care setting for any target group, although a trial for children at risk of behavioural problems is due to report its findings imminently (UK Clinical Research Network identifier: 18423).25 However, that trial does not target children in care and will not include children with RAD. Finally, although the VIPP-SD has been trialled for children who have been adopted, (see Juffer et al.24 and van den Dries et al.17) no studies, to our knowledge, have tested the effectiveness of the VIPP-SD for children in foster care at the time of the current study (but see Schoemaker et al.,26 who have recently published the findings from their study with foster children in the Netherlands).
Although we currently lack evidence regarding the most effective treatments for RAD, the most promising approach for young children with difficulties falling under this rubric (primarily, failing to show attachment behaviour when distressed) is to focus on improving parental awareness and understanding of the child’s distress, and encouraging comfort-seeking by supporting what contemporary attachment theory and research indicates is the central driver of secure attachment: parental sensitive responsiveness. Such an intervention would also benefit from incorporating support for carers in managing challenging behaviour.27 The VIPP-SD represents the most thoroughly tested video-feedback intervention for promoting sensitive responsiveness, includes techniques for behaviour management and is specifically recommended by NICE for treating attachment problems for children in care. It is, therefore, a strong candidate for the treatment of RAD symptoms in the foster care context.
Correctly reading and being consistently sensitive and attuned to a child’s attachment cues may be maximally difficult; therefore, enhanced support and training may be necessary when a child has attachment problems and a complex and traumatic history. A recent modified VIPP-SD programme designed for children in foster care [the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline, Foster Care (VIPP[SD]-Foster Care or VIPP-FC for short)]28 pays particular attention to the need to help carers recognise signals, which may be quite challenging and difficult to understand, that are more commonly observed in children in foster care, so that the carers are better equipped to respond sensitively and to support the child’s secure attachment to them as their carer. In particular, children in foster care tend to demonstrate attachment signals that are very subtle, highly distorted or absent, for example not crying when hurt because they are not used to being comforted, or becoming angry or fearful when comforted. By helping foster carers become aware of these subtle, distorted or absent signals and training them to respond appropriately, it is hoped that the child can learn that foster carers can be relied on in times of need and that it is safe to show their distress and seek comfort. For many children in foster care, their experience of physical interactions with carers has been extremely negative; hence, the VIPP-FC also specifically addresses how to gently and sensitively support a child’s needs for physical contact and comfort.28
Rationale for the study
There is an urgent need to address the lack of evidence underpinning prevention and intervention work for young children in foster care with attachment needs.13 The current report presents the results of a feasibility study investigating the acceptability of the VIPP-FC and the practical feasibility of implementing a randomised study of its efficacy. As part of this feasibility work, we explore the views of foster carers and professionals about the challenges of and barriers to supporting children with attachment needs in the foster care context, and the challenges of and potential solutions to running a research trial in this context. We undertook a small-scale trial to test a range of critical feasibility questions and conducted qualitative interviews with recipients of the VIPP-FC to better understand its strengths and limitations and foster carers’ experiences of the process of change. The present study represents an important step towards addressing a serious gap in the capacity of the NHS and social care services to meet the needs of looked-after children, in a context in which comparatively few research trials of therapeutic interventions have been undertaken.
Overview of study aims and design
In this study, we aimed to conduct a series of studies that represent key preparatory steps necessary to pave the way for a full-scale randomised trial of the VIPP-FC for children in foster care, who are at risk of attachment difficulties. This study comprised the following:
- Modifying the existing VIPP-FC clinical manual to be suitable for the UK foster care context and to meet the requirements of children with attachment difficulties commonly presenting among children in foster care, such as those under the rubric of the RAD label.
- Testing the acceptability of the intervention from the point of view of practitioners and foster carers, and working with local authorities, foster carers, parents and young people to establish the optimal systems, procedures and ethics considerations required to identify and support children with attachment difficulties in UK foster care populations.
- Investigating the feasibility of a randomised controlled trial (RCT) of the modified intervention.
The study was divided into three phases. Phase 1 involved the refinement of the VIPP-FC manual through iterative consultation with an expert advisory group (including the developers, expert clinicians and foster carers), leading to the production of an initial, revised treatment manual. Phase 2a involved the initial testing of the treatment (no random allocation) with a small series of children with RAD-type difficulties and their foster carers, the results of which informed a further revision of the VIPP-FC clinical manual; in parallel with this, phase 2b involved a scoping study of the organisational, ethics and practical landscape within which a trial of VIPP-FC for foster children would need to operate. Phases 1 and 2 informed the final research protocol for the feasibility trial conducted in phase 3. Phase 3 involved recruiting a new group of children in foster care and undertaking a pilot RCT of VIPP-FC (with random allocation). This last phase also included a series of qualitative interviews with the recipients of the VIPP-FC to illuminate feasibility and acceptability questions.
As a treatment development and feasibility study, we adopted a mixed-methods approach, in which quantitative and qualitative data were collected sequentially and integrated at the analysis stage to obtain a better understanding of the treatment development process; the organisational and professional context that will constrain the operation of a future trial; and carers’, practitioners’ and care managers’ experiences and views of the programme, as well as evaluating the feasibility of a randomised trial using a small-scale pilot. In doing so, we adopted a pragmatic implementation-focused approach to establishing the initial feasibility of evaluating a complex intervention such as this, in line with the approach advocated in the Medical Research Council’s guidance.29
The clinical intervention and the assessment framework were grounded in attachment theory and methods, which conceive of attachment as a critical biobehavioural process that develops in the context of routine caregiving interactions, serving to support children’s needs for comfort when they are anxious or feel vulnerable.21 In addition to providing a rich and evidence-based account of the environmental mechanisms that shape the development of attachment (mechanisms which are the targets of attachment-focused interventions), attachment research provides a well-developed set of systematic and rigorously evaluated tools for measuring attachment at different ages. In the current study, we used gold-standard instruments for evaluating attachment difficulties [the Disturbances of Attachment Interview (DAI) and the Strange Situation Procedure] to show that their use is feasible in a clinical trial in this context, which will ensure confidence in the findings of any future full-scale trial.
Data management
The data in all phases of this study were collected and processed in accordance with the Data Protection Act (1998)30 and the General Data Protection Regulation (2018).31 Management of the data was overseen by the chief investigator with support from the Trial Co-ordinating Team. Study data were collected by an experienced research assistant who had been trained to work with high-risk populations, with support from one or two other research assistants. Regular supervision by the chief investigator, Trial Co-ordinating Team and research assistants ensured the reliability of data collection. When necessary, the research assistants were fully trained and certified in administering all research measures. For data that required coding using standardised measures, we employed trained reliable coders, ensuring sufficient inter-rater reliability among coders. Although a number of NHS trusts and higher education institutions were involved in this study, all data were collected, collated and stored at University College London (UCL).
All data collected containing non-identifiable information were entered into a Research Electronic Data Capture (REDCap) database (Vanderbilt University, Nashville, TN, USA), a secure web application for building and managing online surveys and databases.32,33 A master log of participants who were randomised was kept in the trial master file, detailing names and randomisation codes. Paper forms were kept in a locked filing cabinet, and electronic files were kept in an encrypted hard drive and on the UCL Data Safe Haven platform. Screening data and consent forms signed online were completed in REDCap within the UCL Data Safe Haven, as they contained identifiable information. Video- and audio-recordings were stored in the UCL Data Safe Haven or Citrix (Citrix Systems, Inc., Fort Lauderdale, FL, and Santa Clara, CA, USA), two secure and accredited technical solutions for storing, handling and analysing identifiable data.
Study management
Structured oversight of the project was undertaken by a Trial Steering Committee (TSC) and a Data Monitoring and Ethics Committee (DMEC). Both had an independent chairperson and the recommended proportion of independent members (subject experts and a public member), and were convened in accordance with guidelines for the NIHR HTA programme. The TSC and DMEC met regularly to guide the conduct of the study and agreed the details of project set-up, initiation and changes to the design and supervision of the study.
Ethics amendments and protocol modifications
During the study, we submitted three substantial amendments and five non-substantial amendments. See Appendix 1 for an outline of the reasons for the amendments.
The protocol went through six versions. The key changes introduced in the earlier stages of the study were (1) a mechanism to facilitate access to participants (to avoid the team being dependent on the return of paper questionnares to contact foster carers) by adding the possibility of social workers obtaining verbal consent from foster carers for their contact details to be passed on to the research team, and (2) allowing the possibility for the RCT to begin before the case series ended to avoid delaying the start of the RCT owing to difficulties in recruiting to the case series. After the RCT began, the key changes to the protocol were as follows: (1) adding online screening to aid recruitment; (2) the introduction of a reward for participants returning screening questionnaires (either on paper or online) to aid recruitment; (3) a change in target population – opening up the eligibility criteria to allow children who did not meet the criteria for RAD as defined by the DSM-5; this was a solution agreed with the TSC to allow thorough testing of the intervention; (4) allowing practitioners other than Child and Adolescent Mental Health Services (CAMHS) professionals to deliver the intervention to increase clinical capacity; (5) the addition of new sites; and (6) an extension of study dates. See Appendix 1 for an outline and dates of approval of these changes.
Patient and public involvement
Involvement of foster and kinship carers was integral to this study: in its preparation, in the refinement of methods and procedures throughout, and in the dissemination of the findings and discussions regarding a future trial.
The research team included an experienced foster carer who was closely involved, particularly in the early stages of the study, in setting up and refining the procedures. For example, this foster carer team member recommended that carers be offered the possibility of completing screening online and that a contact sheet should be the first step in the online screening to allow us to contact foster carers even if they did not complete all of the steps of the online screening. They also supported the introduction of a voucher to encourage and thank participants for completing the screening questionnaires (until this point, participants were rewarded after baseline and follow-up assessments only). This foster carer team member was also involved in the development of the modified treatment manual. In addition, we recruited one foster carer to sit on the DMEC and another to sit on the TSC.
We established a foster carers advisory group composed of three members, which contributed to several aspects of study design, implementation and dissemination. The foster carers advisory group members were appropriately supported by the study team and remunerated for their time in accordance with INVOLVE guidelines.34 Owing to ongoing difficulties in scheduling face-to-face meetings at times that worked for all three members, this group provided their input remotely. One of the key aspects of the study about which we consulted this group was the screening packs; specifically, in the face of the low return rate in the case series (see Chapter 3), we intended to rethink the packs, fine-tune their contents and make them more attractive. Carer feedback was incorporated into the substantial amendment, such as the introduction of a colourful front sheet with a summary of what is required and rewording the participant information sheet to make it clearer that we were interested in hearing from everyone, even if they thought that the social and emotional problems described did not apply to the child in their care. They were also consulted for their opinions on the usefulness of adding the online screening and to get their feedback on the qualitative interview schedules.
We also consulted the Parent and Young People Panel from the Anna Freud National Centre for Children and Families about the screening packs and its feedback was incorporated in the packs, specifically, changing the order of the questionnaires in the pack to have the ‘friendlier’ one first and rewording instructions to avoid missing data, which initially occurred with one of the questionnaires (on which it was not clear that a respondent was required to answer all questions).
It is also important to note that, in the context of the feasibility nature of the case series and pilot RCT, we continuously asked participating foster carers for their views regarding the study procedures and measures. For example, as a result of this feedback, we offered participants the possibility of completing the screening questionnaires during a home visit; we kept the out-of-home research visits short and in locations that were easy for participants to get to; we provided extra instructions and support to complete the outcome measure that carers had more difficulty with (the computer-based questionnaire); and we introduced communications by text message, as this was a preferred method for many foster carers. It was clear that most foster carers had a preference for face-to-face contact with the research team and that they often experienced what one of them called ‘questionnaire fatigue’. This is an obstacle for a recruitment system that relies on questionnaire return, as the questionnaires often get ‘thrown onto the pile’ without being given appropriate consideration. We introduced several changes (the key changes are outlined in Ethics amendments and protocol modifications) to deal with this frequently reported obstacle.
A crucial patient and public involvement part of this study was the running of two conferences/seminars for all stakeholders: one mid-study, in September 2018, and another near the end of the study, in December 2019. Both were half-day, free events, during which we presented the project and preliminary findings and heard from world-renowned guest speakers, who were all experts in attachment and development of looked-after children. The events were very well received, with an audience that included foster carers, social workers, service managers and VIPP-SD/VIPP-FC interveners. The second event included a foster carers’ forum, where carers who had participated in the study discussed their experiences and insights and offered feedback to the study team. A key learning point from these events was that foster carers enjoyed contributing to the research, both those who received the intervention and those who did not, once they were ‘in’. This reinforces our conclusion from the conversion numbers in earlier stages versus later stages of the study (discussed in more detail in Chapter 5) that, once in direct contact with the team, foster carers tended to find the study very acceptable. Foster carers who could not attend the events were very pleased to receive the final study newsletter with a summary of the findings.
Feedback from the foster carers at all stages of the study was invaluable. In future studies involving this population, foster carer involvement should be sought at all stages of the project, bearing in mind that flexibility is needed to accommodate their busy schedules and child-care commitments.
Timeline
The study began in May 2017 and the final outcome assessments from the feasibility RCT were completed in January 2020. As outlined in Chapter 5, Results and Discussion there were numerous challenges in identifying and recruiting foster carers to the trial, which meant that, among other significant adjustments to the initial design, the timeline for recruitment was extended considerably: originally planned to cover March 2018–March 2019, recruitment to the feasibility and pilot trial began in May 2018 and ended in September 2019.
The methods, the results and an interim discussion for each study phase are presented separately in the following chapters, followed by a general discussion and conclusions.