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

NCT06261463 · University of Illinois at Chicago
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Official title
Leveraging Implementation Science and Design Methods to Sustain Community-based Mental Health Services for Refugees
About this study
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.
Eligibility criteria
To participate in the study, the families must meet the following criteria: 1. Country of origin: Iraq, Syria, Lebanon, Jordan, Palestine or Yemen 2. refugee family living in Chicago \< three years 3. Contains at least one adult caregiver (18-55) and at least one of their children (age 12 and older) living in one household 4. One family member with \> 3 on the GHQ-12 5. able to give written informed consent. Exclusion criteria for refugee families: 1. Not from one of the following Arabic-speaking countries in the Middle East: Iraq, Syria, Jordan, Lebanon, Palestine, Yemen 2. men and women who do not have least one child aged 12 years and older living in one household 3. arrived in the U.S as a refugee greater than 3 years ago 4. persons with developmental disabilities which would preclude their participation in the adapted CAFES intervention 5. persons with severe mental health (e.g., suicidality psychotic disorder), active substance use or current in family crisis (e.g., domestic violence, divorce proceedings).
Study design
Enrollment target: 74 participants
Allocation: randomized
Masking: single
Age groups: child, adult
Timeline
Starts: 2024-05-31
Estimated completion: 2026-08-30
Last updated: 2025-10-01
Interventions
Behavioral: CAFES2
Primary outcomes
  • Changes in feasibility of the intervention via the Feasibility of Intervention Measure (immediate post-intervention)
  • Changes in acceptability of the intervention via the Acceptability of Intervention Mesure (immediate post-intervention.)
  • Changes in PTSD symptoms via the PTSD Checklist (adult, exploratory) (baseline, immediate post-intervention and 6-week follow up)
Sponsor
University of Illinois at Chicago · other
With: National Institute of Mental Health (NIMH)
Contacts & investigators
ContactMary Bunn, PhD · contact · mbunn@uic.edu · (312) 355-2136
InvestigatorMary Bunn, PhD · principal_investigator, University of Illinois Chicago
All locations (1)
University of Illinios ChicagoRecruiting
Chicago, Illinois, United States
Hybrid Type 1 Randomized Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families · TrialPath