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

University of Illinois

Status: Enrolling

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

Treatments: Behavioral: CAFES2

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06261463

K01MH128524-01A1 (U.S. NIH Grant/Contract)

2023-0326

Details and patient eligibility

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 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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 12 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

CAFES2 family and social strengthening intervention

Experimental group

Description:

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.

Treatment:

Behavioral: CAFES2

Enhanced Control

No Intervention group

Description:

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.