Optimizing Multicomponent Interventions to Improve Child Mental Health Following Reintegration From Institutions: Protocol for a Factorial Randomized Trial.

Background: The legacy of the Soviet childcare system has contributed to persistently high rates of child institutionalization across many countries in Eastern Europe, the Caucasus and Central Asia. Although countries throughout the region have adopted deinstitutionalization and family reunification policies, most programs provide limited support to address children's mental health needs or family functioning during the critical transition from institutional care to family and community reintegration. Objective: This study compares and optimizes 3 prevention and early intervention approaches to improve mental health outcomes for children with a history of institutional care. Using the multiphase optimization strategy, the study experimentally evaluates which interventions-family strengthening, trauma-focused child mental health services, or economic empowerment-yield meaningful improvements in child mental health. Methods: This randomized clinical trial used a full 2³ (2×2×2) factorial design. A total of 439 children aged 7 to 12 years with a history of institutional placement and subsequent family reunification, along with 305 primary caregivers (parents or kin caregivers), were recruited from the 3 largest cities in Azerbaijan. Participants were randomly assigned to 1 of 8 experimental conditions, each receiving different combinations of the 3 interventions plus usual care. The family strengthening intervention consisted of a 12-session multifamily group program designed to improve parent-child relationships and supportive parenting. The asset-based economic empowerment intervention included opening a Matched Child Development Account with a US $50 seed deposit, 2:1 matched savings up to US $20 per month, and an 8-week financial education program for caregivers and children. Data on child mental health outcomes (self-esteem, depression, posttraumatic stress disorder, attention-deficit/hyperactivity disorder, internalizing and externalizing problems), cognitive and social processes (executive functioning, working memory), social and academic functioning (eg, grades), family functioning, and economic well-being were collected at baseline, 1-year, and 2-year follow-ups using multi-informant surveys (child, caregiver, and teacher reports), digital cognitive tasks (Wechsler Intelligence Scale for Children, Fifth Edition and Cambridge Neuropsychological Test Automated Battery), and clinical assessments. Results: Recruitment occurred between 2022 and 2023, with 2-year follow-up data collection completed in 2025. Intervention effects analyses are ongoing and are expected to be completed in 2026. Conclusions: This study will identify the most effective and efficient combination of interventions to support the mental health of children reintegrating from institutional care. The findings are expected to provide important evidence to support deinstitutionalization and family reunification initiatives in the region and strengthen the global evidence base on effective, scalable community-based interventions addressing multilevel determinants of mental health among at-risk children in low- and middle-income countries.