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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-55
SponsorUniversity of Illinois at Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: CAFES2 family and social strengthening interventionExperimental treatment 1 intervention
Group B: Enhanced ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
immediate post-intervention
2

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

Time frame
immediate post-intervention.
3

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.

Time frame
baseline, immediate post-intervention and 6-week follow up
4

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.

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

Secondary outcomes

1

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

This measure assesses diverse forms of social support using a 5-point likert scale. Higher overall scores indicate greater degree of available support.

Time frame
baseline, immediate post-intervention and 6-week follow up
2

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

The Duke Social Support Index, Social Interaction Subscale assesses diverse types of daily social interactions. Higher scores indicate greater degrees of social interaction.

Time frame
baseline, immediate post-intervention and 6-week follow up
3

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

Likert scale (1-7) that assesses degree of family support. Higher scores indicate greater degress of family support.

Time frame
baseline, immediate post-intervention and 6-week follow up
4

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

The Dimensions of Parenting, Warmth and responsiveness sub-scale assess the nature and quality of the parent-child relationship using a 3-point likert scale (1-3). Higher scores indicate greater degree of parent-child warmth and responsiveness.

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

Other outcomes

Sponsors and contacts

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University of Illinois at Chicago

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator