Children entering foster care are at high risk of poor mental health. In this single-blind, cluster-randomized phase 3 trial, 382 families with 488 0-5-year-old children, entering foster care, were randomized to the New Orleans Intervention Model (NIM) or social work services as usual (SAU). NIM offers infant mental health assessment (~3 months) and treatment (6-9 months) to children and to their birth and foster families, aiming to improve child mental health and recommend return home or adoption. The principal outcome was child mental health, as measured by the Strengths and Difficulties Questionnaire Total Difficulties (SDQ-TD) scale at 2.5 years after study entry. In total, 286 families (149 NIM and 137 SAU, 367 children) were followed-up (79.4%). Intention-to-treat analysis found no intervention effect of NIM: mean (s.d.) SDQ-TD NIM, 11.5 (7.6); SAU, 11.1 (7.2); adjusted mean difference (NIM - SAU), 1.4; 95% confidence interval (-0.63, 3.53); P = 0.17. No within-trial effects for primary or secondary outcomes were observed. Despite its components being delivered to a high standard, the UK legal context surrounding NIM led to it being impossible to deliver to all eligible families, and less than 70% of families received the intervention to which they were randomized. Future research will be required to evaluate NIM in more favorable social and legal contexts. ClinicalTrials.gov registration: NCT02653716 .

BACKGROUND:Children in foster care who have experienced abuse and neglect are at risk of poor long-term health and societal outcomes. Evidence on the costs, benefits and cost-effectiveness of early interventions aimed at improving the mental health of abused and neglected children is limited. METHODS:This study reports the within-trial economic evaluation alongside BEST?, a randomized controlled trial comparing the New Orleans Intervention Model (NIM) with services as usual (SAU), targeting children aged 0-60 months entering UK foster care.In line with guidance for conducting economic evaluations of complex and social care interventions, a cost-utility analysis (CUA) estimated incremental cost of NIM per quality-adjusted life year (QALY); a cost-effectiveness analysis estimated incremental cost per unit improvement in child mental health; and a cost-consequence analysis combined costs with broad-ranging outcomes. RESULTS:NIM is significantly more costly than SAU (NIM: £10 002; SAU: £4336), with wide cost variations according to context. There are no significant differences between NIM and SAU in QALYs or child mental health. CONCLUSIONS:Within the current UK care systems, NIM is not a cost-effective alternative to SAU. However, these results need to be interpreted with caution and within the prevailing service provision context.

In many families where children have a social worker, parents have experienced challenges in their own childhoods or have neurodevelopmental conditions. These families often endure significant stress, which is frequently worsened by financial or housing challenges. This added pressure can strain relationships and increase the risk of child maltreatment, as well as contribute to mental health issues in children. Relationship-focused interventions show promise in preventing child maltreatment, although there are currently no interventions that simultaneously address neurodevelopmental conditions and the impact of poverty. We have co-produced, alongside parent experts-by-experience, local stakeholders, and infant mental health practitioners, a new service called Infant Parent Support (IPS). IPS will i) adopt a relationship-focused approach to comprehensive understanding of family functioning, ii) incorporate child and parent mental health and neurodevelopmental awareness, and iii) ensure a poverty aware approach throughout. The aim of this phase is to investigate the feasibility of a definitive Randomised Controlled Trial (RCT) of IPS compared with services-as-usual (SAU). The study settings are social care services in two local authorities: Glasgow City Council (Scotland) and the London Borough of Bromley (England). Our target population is children on a ‘child in need’ plan (or the Scottish equivalent) and eligible participants are families where i) the infant(s) are aged 0–5 years and ii) the family has an allocated social worker plus a multi-agency support plan. Thirty participants will be identified by social workers and randomised to receive either IPS or SAU. Families randomised to IPS will receive an intensive multidisciplinary attachment-focused assessment that provides a foundation for relationship-focused interventions. IPS will incorporate child and parent mental health and neurodevelopmental awareness and ensure a poverty aware approach throughout. Families randomised to SAU will receive the assessment and support that social care services normally implement. We will utilise a pre-post and 3/6-month follow-up design with embedded mixed-method process evaluation and exploratory economic analysis. The primary objective is to assess if enough families can be recruited, randomised, and retained in the trial such that a full-scale RCT is likely to be feasible. The secondary objectives are to assess the acceptability and feasibility of the planned outcome measures and the IPS intervention to families and professionals. A service like IPS, that uses a relationship-focused approach to child and parent mental health, neurodevelopmental and money/housing problems, has never previously been tested. Therefore, there are several areas of uncertainty that need to be addressed before moving onto a definitive RCT. Registered in ClinicalTrials.gov Identifier: NCT06003582. Co-production and Feasibility RCT of Intervention to Improve the Mental Health of Children with a Social Worker. Registered 22/08/2023. https://classic.clinicaltrials.gov/ct2/show/NCT06003582 .

Background Maltreated children are at high risk of negative psychosocial outcomes. Interventions targeting their foster carers are modestly effective. No previous RCT has targeted birth families of maltreated children in foster care. Methods In this single-blind, cluster-randomised, phase 3 trial (Registration: BeST? Clinicaltrials.gov: NCT02653716), families with a 0-5-year-old child entering foster care in Glasgow or London were randomised 1:1 (secure web portal; researchers masked; stratification by site with minimisation) to the New Orleans intervention model (NIM) or social work services-as-usual (SAU). NIM offers infant mental health assessment (~3 months) and treatment (6-9 months) to birth families and children in foster care, aiming to improve child mental health and recommend return home or adoption. The principal outcome measure of child mental health was the 20-item Strengths and Difficulties Total Difficulties (SDQ-TD) Scale at 2.5 years post study entry (high scores indicating poorer child behaviour). Findings Between January 2012 and July 2021, 382 families (488 children) were recruited: 22 families were later deemed non-eligible leaving 360 families (439 children; 47.0% female). Follow-up continued until December 2023 when the trial was fully powered: 286 families (149 NIM; 137 SAU, 367 children) were followed up at 2.5 years (79.4%). Intention-to-treat analysis found no intervention effect of NIM: Mean (SD) SDQ-TD NIM 11.5 (7.6); SAU 11.1 (7.2); adjusted mean difference (NIM-SAU) 1.4; 95% CI (-0.63, 3.53); p=0.17. Girls randomised to NIM had higher SDQ-TD scores at 2.5 years wrt SAU: Interaction p=0.0217; adjusted mean difference 2.96; (0.12, 5.82); p= 0.042 - adjusted mean difference in boys was 0.12; 95% CI (-2.82, 3.09). Of 52 SAEs (21 NIM; 31 SAU), none were intervention related. Within the trial time horizon, NIM is not cost-effective costing £10,592 per child versus £4557 for SAU. Interpretation Contextual challenges meant only 66.4% of eligible families received NIM. Despite no measured within-trial effects for SDQ-TD, higher scores in girls randomised to NIM could indicate either poorer mental health or, conversely, a process of recovery. Follow-up is therefore essential. Funding National Institute for Health Research (PHR 12/211/54)

AbstractBackgroundChildren in foster care are at high risk of future mental health and developmental difficulties. A number of interventions may be helpful; however, the effectiveness of interventions specifically for pre‐school children in foster care is not well established. This is an important omission, since infancy and early childhood may be the optimal period for interventions to prevent future problems. The current systematic review set out to establish the existing evidence base for interventions to improve social‐emotional, developmental and relational outcomes for pre‐school children in foster and kinship care.MethodsSearches of online databases were undertaken in June 2023 with keyword search terms related to the study population and design. Studies utilising a randomised control design to measure the effectiveness of interventions for foster children aged 0–7 years were included. The methodological quality of included studies was assessed using the Cochrane Risk of Bias (ROB‐2) tool and effects evaluated using narrative synthesis and GRADE assessments of included interventions and outcomes.ResultsSearches identified 6815 results. Twenty studies, describing seven interventions, met inclusion criteria. Fifteen studies reported intervention benefits comparative to control in at least one outcome domain, with particularly good evidence for Attachment and Behaviour Catch‐Up (ABC) in improving developmental outcomes. There was also evidence for Multi‐Treatment Foster Care for Pre‐Schoolers (MTFC‐P), Kids In Transition To School (KITS), Parent‐Child Interaction Therapy (PCIT) and HeadStart in improving behavioural outcomes. The findings for relational outcomes, including attachment, were mixed; however, there was some evidence for MTFC‐P and ABC in reducing avoidant attachment.ConclusionsThis systematic review contributes to our current understanding of how we might best support pre‐school children in foster care. It remains unclear whether the effectiveness of particular interventions may be moderated by participant or intervention characteristics. Further research is needed to understand which interventions work best for whom in this group. Despite some variability in methodological quality and heterogeneity across studies, our findings suggest that certain interventions are likely to be helpful for young children in foster care. Dissemination and ongoing evaluation of the evidence‐based interventions highlighted within this review should be implemented in clinical practice.

BackgroundChildren in foster care are at high risk of negative outcomes. The context surrounding the child, including family, is crucial in supporting resilience.ObjectiveA randomised controlled trial was conducted to examine the clinical and cost-effectiveness of an infant mental health intervention novel to the UK context. To examine the components of and fidelity to the intervention, and the interplay between the intervention and its contexts, we conducted a realist process evaluation.Participants and settingThe study settings were two UK sites, each with a very different legal context: In one, children's journeys through care are overseen by judge-led legal processes with strict timescales. In the other, care journey's are mainly made by lay tribunals, with no externally imposed timescales. Our participants were families involved in the child welfare system and stakeholders from a variety of agencies (including social services, legal, health)MethodsWe conducted 200 qualitative interviews and focus groups with multi-agency informants, and quantitative data on families' access to the intervention and fidelity. Thematic analysis enabled development of context-mechanism-outcome pattern configurations, to examine mechanisms of and barriers to intervention delivery.ResultsWe found that, although individual intervention components can be delivered with fidelity in the UK, contextual constraints prevent delivery as designed for all families who might benefit from it.ConclusionsWe suspect that, for this intervention to operate effectively, it should be delivered in a system with authoritative legal oversight with statutory timescales, sufficient time to enable families to be offered a trial-of-treatment, dual registration of foster carers as potential adopters and for the infant mental health intervention to be fully embedded within an integrated social care and family justice system.

In 2011, a randomized controlled trial (RCT) of a mental health intervention for families with children under the age of 5 years coming into the Scottish care system was launched, called the Best Services Trial (BeST). When attempts were made to expand the study to English sites, the local leadership Judge objected, concerned that randomization in family proceedings was unfair, potentially discriminatory, and unlawful. Considerations about parental consent, fairness of randomization, and an understanding that the new intervention might be no better, or even harmful, compared to current best practices were crucial in addressing these concerns. In 2017, BeST was launched in England utilizing a randomized methodology. Significant input into the design of BeST came from the leadership Judge who had previously considered randomization unlawful. In July 2021, 383 families with 488 children had been recruited across both Scottish and English sites. Follow-up continues and 76 per cent of families continue to participate at 2.5 years after entering the study. Although there were undoubted challenges in designing and implementing BeST, with hindsight, the objections raised to the testing of interventions randomly were demonstrably resolvable and the process of randomization encountered no legal challenges. This is the first time an RCT has been accommodated within live proceedings in the family justice arena in England and Wales and one of a relatively few such RCTs conducted internationally.

Abstract Background Abused and neglected children are at increased risk of health problems throughout life, but negative effects may be ameliorated by nurturing family care. It is not known whether it is better to place these children permanently with substitute (foster or adoptive) families or to attempt to reform their birth families. Previously, we conducted a feasibility randomised controlled trial (RCT) of the New Orleans Intervention Model (NIM) for children aged 0–60 months coming into foster care in Glasgow. NIM is delivered by a multidisciplinary health and social care team and offers families, whose child has been taken into foster care, a structured assessment of family relationships followed by a trial of treatment aiming to improve family functioning. A recommendation is then made for the child to return home or for adoption. In the feasibility RCT, families were willing to be randomised to NIM or optimised social work services as usual and equipoise was maintained. Here we present the protocol of a substantive RCT of NIM including a new London site. Methods The study is a multi-site, pragmatic, single-blind, parallel group, cluster randomised controlled superiority trial with an allocation ratio of 1:1. We plan to recruit approximately 390 families across the sites, including those recruited in our feasibility RCT. They will be randomly allocated to NIM or optimised services as usual and followed up to 2.5 years post-randomisation. The principal outcome measure will be child mental health, and secondary outcomes will be child quality of life, the time taken for the child to be placed in permanent care (rehabilitation home or adoption) and the quality of the relationship with the primary caregiver. Discussion The study is novel in that infant mental health professionals rarely have a role in judicial decisions about children’s care placements, and RCTs are rare in the judicial context. The trial will allow us to determine whether NIM is clinically and cost-effective in the UK and findings may have important implications for the use of mental health assessment and treatment as part of the decision-making about children in the care system.

We argue that major health and social care policy initiatives are not too complex for randomised controlled trial (RCT) methodology and illustrate this using the example of the Best Services Trial (BeST?): a RCT of an infant mental health intervention for maltreated children. We suggest that qualitative research, as a core part of the trial process from conception and development through to implementation and evaluation, is crucial in building, understanding and strengthening the partnership required to drive such a complex trial. Data pertinent to trial implementation demonstrate the iterative nature of the process whereby stakeholders are consulted and their views influence the conduct of the trial. Here we reflect on the bi‐directional relationship between qualitative data collection and partnership‐working in a trial. For very complex trials to be possible, significant resource needs to be available for the qualitative component.Key Practitioner Message: • Qualitative research is key to understanding, building and strengthening partnership approaches to researching complex interventions; • Qualitative research is vital to supporting randomised controlled trials involving multiple sectors; • Qualitative research provides essential explanatory power to outcome data in research.

Child maltreatment is associated with life-long social, physical, and mental health problems. Intervening early to provide maltreated children with safe, nurturing care can improve outcomes. The need for prompt decisions about permanent placement (i.e., regarding adoption or return home) is internationally recognised. However, a recent Glasgow audit showed that many maltreated children “revolve” between birth families and foster carers. This paper describes the protocol of the first exploratory randomised controlled trial of a mental health intervention aimed at improving placement permanency decisions for maltreated children. This trial compares an infant's mental health intervention with the new enhanced service as usual for maltreated children entering care in Glasgow. As both are new services, the trial is being conducted from a position of equipoise. The outcome assessment covers various fields of a child’s neurodevelopment to identify problems in any ESSENCE domain. The feasibility, reliability, and developmental appropriateness of all outcome measures are examined. Additionally, the potential for linkage with routinely collected data on health and social care and, in the future, education is explored. The results will inform a definitive randomised controlled trial that could potentially lead to long lasting benefits for the Scottish population and which may be applicable to other areas of the world. This trial is registered with ClinicalTrials.gov (NC01485510).