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

NCT06261463 | Recruiting

• 2 other identifiers: 2023-0326K01MH128524-01A1
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• Changes in feasibility of the intervention via the Feasibility of Intervention Measure

  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.

  immediate post-intervention

• Changes in acceptability of the intervention via the Acceptability of Intervention Mesure

  4-item measure assess the degree to which the intervention is viewed as agreeable or satisfactory, with higher scores indicating greater acceptability

  immediate post-intervention.

• Changes in PTSD symptoms via the PTSD Checklist (adult, exploratory)

  PTSD Checklist utilizes a 5-point likert scale (0-4) to assess post traumatic stress symptoms. Higher scores indicate increasing levels of PTSD.

  baseline, immediate post-intervention and 6-week follow up

• Changes in adult depression and anxiety via the Hopkins Symptom Checklist (HSCL, adult, exploratory)

  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.

  baseline, immediate post-intervention and 6-week follow up

• Changes in youth depression and anxiety via the Arab Mental Health Scale (youth, exploratory)

  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.

  baseline, immediate post-intervention and 6-week follow up

• Changes in PTSD in children and youth via the Child Revised Impacted of Events Scale (CRIES, youth, exploratory)

  CRIES is a measures to assess PTSD symptoms in children and youth. Higher total scores indicate higher PTSD symptoms.

  baseline, immediate post-intervention and 6-week follow up

• Changes in post-migration stress in youth and adults via the Refugee Post-Migration Stress Scale

  The post-migration stressors scale assess stress in youth and adults. Higher total scores indicate higher levels of stress.

  baseline, immediate post-intervention and 6-week follow up

Secondary Outcomes (5)

• Changes in social support via the Medical Outcomes Study (MOS) Social Support Survey

  baseline, immediate post-intervention and 6-week follow up

• Changes in social interaction via the Duke Social Support Index, social interaction subscale

  baseline, immediate post-intervention and 6-week follow up

• Changes in family support via the Multidimensional Scale of Perceived Social Support (MSPSS, Family Support Sub-scale)

  baseline, immediate post-intervention and 6-week follow up

• Quality of the parent-child relationship via the Dimensions of Parenting Scale (sub-scale, warmth and responsiveness of parent-child relationship)

  baseline, immediate post-intervention and 6-week follow up

• Degree of family strengths and difficulties via the SCORE-15 (family strengths, family difficulties sub-scales

  baseline, immediate post-intervention and 6-week follow up

Study Arms (2)

CAFES2 family and social strengthening intervention

EXPERIMENTAL

Families randomized into CAFES2 receive a home visit and participate in six multiple family group sessions in addition to any outside services or programs they are participating in.

Behavioral: CAFES2

Enhanced Control

NO INTERVENTION

Families randomized to the enhanced control arm will not receive the CAFES2 intervention Instead, they will continue with their usual care, and also receive healthy lifestyle materials.

Interventions

CAFES2 BEHAVIORAL

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.

Also known as: Coffee and Family Education and Support, Version 2

CAFES2 family and social strengthening intervention

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Illinios Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Social Adjustment

Interventions

Coffee; Palliative Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Social Behavior

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mary Bunn, PhD

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Bunn, PhD

CONTACT

(312) 355-2136; mbunn@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Research Assistants (RAs) who will collect both qualitative and quantitative data will be blind to the condition in which study participants are randomized.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The investigators will conduct a randomized controlled trial with refugee families from Arabic-speaking refugee families from the Middle East (n=74). Half of the participants will be randomized to receive CAFES2 and half will be randomized to the enhanced control condition where they will receive ongoing access to services through partner organizations and healthy lifestyle materials.

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 15, 2024
• Study Start: May 31, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)