Delivering a family-based child mental health promotion program among two resettled refugee communities during the COVID-19 pandemic: Lessons learned in a hybrid type II implementation-effectiveness randomized controlled trial.

Background: Resettled refugee families face elevated mental health risks, compounded by structural and cultural barriers. The Family Strengthening Intervention for Resettlement (FSIR), co-developed with resettled refugee communities, aims to improve family functioning and child mental health. This study evaluated FSI-R in Somali Bantu and Bhutanese communities in New England during COVID-19 using a Hybrid Type II Implementation-Effectiveness Trial guided by the EPIS framework.

Methods: Linear mixed modeling assessed changes in family functioning and child mental health. A process evaluation identified implementation barriers and informed adaptations. Activities were registered under Clinical Registry #NCT03796065.

Results: Bhutanese families receiving FSI-R showed greater improvements in parental supervision compared to usual care. Process evaluation highlighted that responsiveness to community needs supported successful implementation despite pandemic stressors. Somali Bantu interventionists reported stronger emotional connection with families during in-person delivery.

Conclusions: Findings support the utility of hybrid trials in assessing both effectiveness and implementation of preventive interventions with resettling families. Despite contextual disruptions, attention to community needs and delivery flexibility enabled successful implementation. This study underscores the importance of context-informed strategies to sustain core elements of evidence-based interventions in dynamic settings.