Infant mental health services for birth and foster families of maltreated pre-school children in foster care (BeST?): a cluster-randomized phase 3 clinical effectiveness trial

Abstract

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 .

Fig. 1. NIM is a complex intervention.

Complex interventions can have several components and several actors and can target a range of behaviors. NIM involves an infant or pre-school child or children, with an experience of or risk of maltreatment, with both their birth and foster family. NIM aims to improve both the child’s mental health and the decisions made about the child’s permanent placement. A timely decision about permanent return home or adoption should facilitate sustained improvements in the child’s mental health.

Fig. 2. NIM in its UK social care and legal context.

Medical Research Council complex interventions guidance states that implementation of a complex intervention can ‘vary across different contexts yet maintain the integrity of the core intervention components’ and that ‘Complexity might also arise through interactions between the intervention and its context’.

Fig. 3. Trial profile.

Study flow diagram was based on CONSORT 2010 guidance: https://www.equator-network.org/reporting-guidelines/consort/. FAS, full analysis set.