NCT06261463 · University of Illinois at Chicago
Hybrid Type 1 Randomized Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families
What this study is about
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 randomly assigned type 1 hybrid effectiveness-implementation design.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Changes in feasibility of the intervention via the Feasibility of Intervention Measure
Time frame: immediate post-intervention
This 4-item measure assesses the degree to which a given intervention is viewed as feasible for a given population and setting. Higher scores are associated with greater degrees of perceived feasibility.
Changes in acceptability of the intervention via the Acceptability of Intervention Mesure
Time frame: immediate post-intervention.
4-item measure assess the degree to which the intervention is viewed as agreeable or satisfactory, with higher scores indicating greater acceptability
Changes in PTSD symptoms via the PTSD Checklist (adult, exploratory)
Time frame: baseline, immediate post-intervention and 6-week follow up
PTSD Checklist utilizes a 5-point likert scale (0-4) to assess post traumatic stress symptoms. Higher scores indicate increasing levels of PTSD.
Changes in adult depression and anxiety via the Hopkins Symptom Checklist (HSCL, adult, exploratory)
Time frame: baseline, immediate post-intervention and 6-week follow up
HSCL measures symptoms of anxiety and depression in adults using a 4-point likert scale (1-4) with high scores indicating higher levels of anxiety and depression symptoms.
Changes in youth depression and anxiety via the Arab Mental Health Scale (youth, exploratory)
Time frame: baseline, immediate post-intervention and 6-week follow up
This scale measures symptoms of anxiety and depression in youth using a 3-point likert scale (0-3). Total scores are associated with mild, moderate or severe anxiety or depression.
Changes in PTSD in children and youth via the Child Revised Impacted of Events Scale (CRIES, youth, exploratory)
Time frame: baseline, immediate post-intervention and 6-week follow up
CRIES is a measures to assess PTSD symptoms in children and youth. Higher total scores indicate higher PTSD symptoms.
Changes in post-migration stress in youth and adults via the Refugee Post-Migration Stress Scale
Time frame: baseline, immediate post-intervention and 6-week follow up
The post-migration stressors scale assess stress in youth and adults. Higher total scores indicate higher levels of stress.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- To participate in the study, the families must meet the following criteria:
- Country of origin: Iraq, Syria, Lebanon, Jordan, Palestine or Yemen
- refugee family living in Chicago \< three years
- Contains at least one adult caregiver (18-55) and at least one of their children (age 12 and older) living in one household
- One family member with \> 3 on the GHQ-12
- able to give written informed consent. Exclusion criteria for refugee families:
- Not from one of the following Arabic-speaking countries in the Middle East: Iraq, Syria, Jordan, Lebanon, Palestine, Yemen
- men and women who do not have least one child aged 12 years and older living in one household
- arrived in the U.S as a refugee greater than 3 years ago
- persons with developmental disabilities which would preclude their participation in the adapted CAFES intervention
- persons with severe mental health (e.g., suicidality psychotic disorder), active substance use or current in family crisis (e.g., domestic violence, divorce proceedings).
Exclusion criteria
- for refugee families:
- Not from one of the following Arabic-speaking countries in the Middle East: Iraq, Syria, Jordan, Lebanon, Palestine, Yemen
- men and women who do not have least one child aged 12 years and older living in one household
- arrived in the U.S as a refugee greater than 3 years ago
- persons with developmental disabilities which would preclude their participation in the adapted CAFES intervention
- persons with severe mental health (e.g., suicidality psychotic disorder), active substance use or current in family crisis (e.g., domestic violence, divorce proceedings).
Where
- Chicago, Illinois
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
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Will I receive a placebo instead of treatment?
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Data: ClinicalTrials.gov · synced Oct 1, 2025 · Source of record for eligibility and locations