Innovative Multi-Level Approaches to Improving Child Mental Health in Azerbaijan: A Factorial Clinical Trial Protocol

Background and Purpose: Mental health care in many post-Soviet countries is largely focused on short-term alleviation of symptoms rather than addressing the social and environmental drivers of psychological distress. In Azerbaijan, chronic socio-economic hardship and prolonged exposure to wars, political instability, and refugee crises has exacerbated mental health risk factors and undermined families’ ability to provide necessary supports to their children. The need for mental health care among caregivers and children often exceeds available resources and capacity. To reduce this service gap, this NIMH-funded clinical trial (ClinicalTrials.gov Identifier: NCT06788028) aims to develop a comprehensive community-based psychosocial intervention package to improve child mental health outcomes related to poverty and adversity in the country.

Methods: The study employs Multiphase Optimization Strategy (MOST) using a fractional factorial design (2^3=8) with eight experimental conditions to test the most optimal combination of intervention components for improving mental health outcomes among children aged 7 to 14. A total of 600 child-caregiver dyads across Azerbaijan will be randomly assigned to one or more arms: (1) group-based family strengthening intervention; (2) asset-based economic empowerment intervention involving Child Development Accounts and group financial education sessions for children and caregivers; and (3) trauma-focused mental health services. These interventions have been adapted to ensure cultural relevance, viability, and practicality, essential for the resource-strained context.

Data will be collected at baseline, one-year, and two-year follow-up using child-, caregiver-, and teacher-reported surveys. Digital, non-linguistic cognitive assessments (WISC-V, CANTAB) and administrative records (e.g., school grades, savings data) will also be utilized. To estimate intervention effects, differences in outcomes will be examined using an intent-to-treat approach and mixed effects models, accounting for repeated measures across time. Intervention effects will be tested by comparing changes from baseline to each follow-up, two-way time-by-intervention interactions (e.g., Family Strengthening × Time), and, for combined interventions, three-way interactions (e.g., Family Intervention × Economic Intervention × Time). Effect coding (–1, 1) will be employed for each intervention to ensure orthogonality and equal power in estimating both main effects and interactions.

Results: The most optimal combination of interventions will be determined for improving child mental health outcomes (e.g., symptoms of depression, anxiety, trauma, disruptive behaviors), cognitive and social processes associated with these outcomes (e.g. attention, executive functioning), and functional outcomes (e.g. academic performance). This study will also examine hypothesized intervention mediators (e.g. supportive parenting, economic well-being) and moderators (e.g. age, gender, family structure) in improving child outcomes. Finally, this study will explore facilitating factors and barriers to implementation and participation in each intervention component at individual, family, and organizational levels.

Conclusions and Implications: This study will identify the synergetic effects of three multi-level interventions targeting social determinants of child mental health in Azerbaijan. This presentation will detail the study’s innovative design, cultural adaptation of instruments and interventions, collaboration with local community members, and results from prior child mental health intervention research in Azerbaijan using a similar design. Findings from this study will provide an effective, community-based intervention strategy that can be scaled across Azerbaijan and potentially extended to the broader region.