Wait-List Controlled Pilot Trial of a Preventive Mental Health Intervention for Refugee Youth.

There is an urgent need for effective, strengths-based interventions that address unique mental health needs of the increasing US population of refugee and immigrant children. "EMPOWER" (Emotions Program Outside the clinic and Wellness Education for Recent arrival) is a preventive mental health and wellness intervention adapted for refugee and immigrant children, which was previously developed by an interdisciplinary team. This pilot, non-randomized, wait-list controlled trial incorporated mixed methods to evaluate preliminary efficacy and implementation of EMPOWER. Children in the intervention (n = 13) vs. control (n = 6) group had findings indicating potential improvement in emotional awareness using Trait Meta Mood Attention to Feelings scores (difference-in-difference 4.7 (95% confidence interval (CI) -5.9, 15.2) points), with findings demonstrating possible clustering by family (intraclass correlation of 18.9%, p = 0.06). Both groups demonstrated improved COVID-19 knowledge. Pediatric Quality of Life scores were higher for the intervention vs. control by an additional 99.2 points (95% CI -82.2, 280.7), although the observed difference did not reach statistical significance, and the scores did not demonstrate evidence of clustering by family (intraclass correlation 0%, p = 1.00). Parents described varying awareness of EMPOWER components, expressed satisfaction with the intervention, and identified a need for longer opportunities for participation. The EMPOWER intervention may support children's emotional awareness and quality of life. Future iterations can include integration directly into educational settings and can assess outcomes related to emotional regulation, emotional awareness, and mitigation of traumatic risk factors over time. Clinical Trials Registration: This study can be found at clinicaltrials.gov, #NCT04931888, where a study record was opened in June 2021, with a start date of May 20, 2022. The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available to protect confidentiality and privacy of participants.