Recruiting

Social Strengthening

Sponsor:

University of Illinois at Chicago

Code:

NCT06261463

Conditions

Depression

Anxiety

PTSD

Family Dynamics

Social Functioning

Eligibility Criteria

Sex: All

Age: 12 - 55

Healthy Volunteers: Not accepted

Interventions

CAFES2

Study Details

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

Study ID

NCT06261463

Start date

May 31, 2024

Status verified date

Sep, 2025

Completion date

Aug 30, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 55

Healthy Volunteers: Not accepted

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

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: CAFES2 family and social strengthening intervention

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.

no intervention: Enhanced Control

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

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 measure

  • Changes in feasibility of the intervention via the Feasibility of Intervention Measure [ Time Frame: immediate post-intervention ]
  • Changes in acceptability of the intervention via the Acceptability of Intervention Mesure [ Time Frame: immediate post-intervention. ]
  • Changes in PTSD symptoms via the PTSD Checklist (adult, exploratory) [ Time Frame: baseline, immediate post-intervention and 6-week follow up ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Mary Bunn, PhD

(312) 355-2136mbunn@uic.edu

Locations

University of Illinios Chicago

Recruiting

Chicago, Illinois, United States, 60612

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2025-10-01.