NCT06261463

Hybrid Type 1 Randomized Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families

Leveraging Implementation Science and Design Methods to Sustain Community-based Mental Health Services for Refugees

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 12 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The proposed study draws on prior research to evaluate the feasibility, acceptability and explore preliminary effectiveness of Coffee and Family Education and Support, Version (CAFES2) using a pilot randomized type 1 hybrid effectiveness-implementation design. CAFES2 is a peer-led family and social strengthening multiple family group intervention that is designed to respond to multi-level needs of refugee families. Results of the trial will contribute to the emerging evidence base on family-based mental health interventions for refugee and newcomer communities. The trial will also generate new insights regarding implementation strategies needed to promote successful delivery of services by peer providers and the unique role of human-centered design practices for adaptation of mental health and psychosocial interventions.

Detailed description

In partnership with refugee service organizations in Chicago, the investigator explored the problems, strengths, and help-seeking preferences of refugee families. Qualitative findings indicated ongoing problems coping with stress, trauma and loss, strain and tension in family relationships and limited social support networks. Participants identified a need for family-focused, group-based services led by individuals with similar life experiences. Based on these findings, the investigators identified an evidence-based multiple-family group model, Coffee and Family Education and Support (CAFES) as a foundational model that could be adapted to meet the needs of refugee families. Drawing on this formative work and strong community partnerships, further research is needed to adapt CAFES to a new population, to reflect multi-level needs of families and for use by refugee peer facilitators in community-based organizations. Research is also needed to assess feasibility, acceptability and fidelity of model implementation, attentive to barriers and facilitators specific to peer-led mental health services and community settings. The investigators will use a hybrid type 1 randomized pilot trial design to achieve the following specific research aims: Aim 1: To adapt the multiple family CAFES model for delivery by peers in community organizations using an implementation science adaptation framework and participatory human-centered design methods to develop an intervention that addresses the complex needs of refugee families. Aim 2: To pilot the adapted CAFES2 model with refugee families from Arabic-speaking countries in the Middle East to examine feasibility, acceptability and provider fidelity when implemented by refugee peers in two community-based organizations in Chicago. (n=74, 37 intervention, 37 control) Aim 3: To explore the impact of the adapted CAFES2 model compared to enhanced control on outcomes of adult and child mental health and family and community support and explore variables expected to mediate the intervention's impact.

Conditions

• Depression
• Anxiety
• PTSD
• Family Dynamics
• Social Functioning
• Family Support
• Family Relations

Interventions

Type	Name	Description
BEHAVIORAL	CAFES2	The adapted CAFES2 model includes an initial home visit and six multiple family group sessions delivered by peer providers. Families include at least one caregiver and one youth 12 years or older. Key model components include: 1) interfamilial discussion of stressors affecting families and family relationships, 2) psychoeducation on the effects of war and forced displacement on individuals, families and social relationships; 3) emotion regulation and self management strategies; 4) identification and activation of family and social strengths, 5) discussion of family identity and hopes for the future in resettlement and 5) discussion of social and community resources to support health and wellbeing. Each group session incorporates didactic components, family and small group discussion, skill building and separate breakout groups for adolescents and adults.

Timeline

• Start date: 2024-05-31
• Primary completion: 2026-08-01
• Completion: 2026-08-30
• First posted: 2024-02-15
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States