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

Leveraging Implementation Science and Design Methods to Sustain Community-based Mental Health Services for Refugees

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; PTSD; Anxiety; Family Dynamics; Social Functioning
• Intervention / Treatment: Behavioral: CAFES2

Detailed 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. Families identified a need for family-focused, group-based services led by individuals with similar life experiences. Based on these findings, we 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.

We will use a pilot randomized type 1 hybrid effectiveness-implementation 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Bunn, PhD; Phone Number: (312) 355-2136; Email: mbunn@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for Families:

• being a resettled refugee family
• having one or more school-aged children aged 12 years and older living with them
• one family member (caregiver or youth) screens for moderate emotional distress

Inclusion Criteria for Adult Caregivers/Parents:

• between ages of 18-45 years old
• arrived to the U.S as a refugee
• have at least one child currently living with them

Inclusion Criteria for Youth:

• between ages of 12 and 17 years old)
• arrived as a refugee
• currently living with at least one caregiver.

Exclusion Criteria:

• not meeting the above inclusion criteria
• families or individual in the midst of a crisis (e.g. family crisis or mental health crisis)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Coffee and Family Education and Support, Version 2
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Hospital Anxiety and Depression Scale (HADS, youth, exploratory)	HADS measures symptoms of anxiety and depression in youth using a 4-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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in social support via the Medical Outcomes Study 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.	baseline, immediate post-intervention and 6-week follow up
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.	baseline, immediate post-intervention and 6-week follow up
Changes in parenting via the Alabama Parenting Questionnaire (adult and youth)	Likert scale (1-5) that includes 5 sub-domains. Each sub-domain results in a summed score that relates to 5 domains of parenting: involvement, positive parenting, poor monitoring/supervision, inconsistent discipline, and corporal punishment.	baseline, immediate post-intervention and 6-week follow up
Changes in family communication via the Family Problem Solving Communication Scale	The Family Problem Solving Communication Scale assess family communication style using a 4-point likert scale with higher scores indicating greater degrees of problem-oriented communication.	baseline, immediate post-intervention and 6-week follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in acceptability of the intervention via the Johns Hopkins University Dissemination and Implementation Science Measure	This measure assess the degree to which the intervention is viewed as agreeable or satisfactory	baseline, immediate post-intervention
Changes in feasibility of the intervention via the Johns Hopkins University Dissemination and Implementation Science Measure	This 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.	baseline, immediate post-intervention

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Mary Bunn, PhD, University of Illinois Chicago

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Estimated): February 15, 2024

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2023-0326; K01MH128524-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No