Addressing Mental Health Disparities in Refugee Children

Study Overview
=================
Brief Summary
-----------------
The proposed study will employ a cross-cultural Community Based Participatory Research (CBPR) approach to build from prior needs assessments and mixed-methods research to evaluate the effectiveness of the Family Strengthening Intervention for Refugees (FSI-R), a preventative family home-based visiting intervention intended to mitigate mental health disparities among refugee children and families using a hybrid implementation-effectiveness design. Results of the investigator's trial will expand the evidence-base on community-based interventions for refugees and has the potential to be replicated to reduce mental health disparities affecting diverse groups of refugee children and families.

Detailed Description
-----------------
Using a CBPR approach, a family based prevention model, the Family Strengthening Intervention for Refugees (FSI-R) was adapted from a tested model used in Africa and designed for delivery by refugee community health workers with through a process involving stakeholder consultation and local refugee Community Advisory Board input. Pilot data on the FSI-R demonstrates strong feasibility and acceptability, but further data are needed on effectiveness as well as barriers and facilitators to implementation by community health workers embedded in refugee-serving social services agencies. Specific aims are to (1) examine the impact of a family-based preventive intervention on outcomes of parent-child relationships, family functioning, and child mental health using a Hybrid Type 2 Effectiveness-Implementation Design (families with children aged 7-17 in a two-arm randomized controlled trial); (2) identify barriers and facilitators to implementation of the FSI-R by community health workers by conducting a process evaluation concurrent with the delivery of the intervention; and (3) strengthen the science of community engagement to address health disparities by fortifying CBPR-based pathways of change via collaborative partnerships between refugee communities, service providers, and academic stakeholders.

Official Title
-----------------
Addressing Mental Health Disparities in Refugee Children Through Family and Community-based Prevention: A CBPR Collaboration and Hybrid Implementation Effectiveness Trial

Conditions
-----------------
Family Research

Intervention / Treatment
-----------------
* Behavioral: FSI-R Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for families: being a resettled refugee family having one or more school-aged children living in the home (aged 7-17) Inclusion Criteria for parents/caregivers: be aged 18 or older cares for and lives in the same household of the children at least 50% of the time is the child'd legal guardian Exclusion Criteria: not meeting the above inclusion criteria families in the midst of a crisis (e.g. active suicide attempts)

Ages Eligible for Study
-----------------
Minimum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators will conduct a Randomized Controlled Trial among Somali Bantu and Bhutanese families (N=300; 150 per group). Half of the families will be randomized to receive the FSI-R and half will be randomized to the control condition where the participants will receive Treatment as Usual (TAU).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FSI-R Treatment<br>Families randomized into the FSI-R Treatment arm will receive the 10-module Family Strengthening Intervention in addition to any outside services or programs they are participating in. | Behavioral: FSI-R Treatment<br>* The FSI-R involves a series of separate and joint meetings with parents and children to discuss challenges the family has faced and the strengths that helped them make it through past challenging times. Additional psychoeducation on mental health and promoting resilience along with coaching to enhance parenting skills is provided throughout and may be tailored to family needs. The FSI-R provides a shared space for refugee families both to recognize their strengths and to problem-solve in a more collective way on family challenges and shared hopes for the future. The FSI-R is delivered in the home, by a trained interventionist, over the course of 10-modules.<br>* Other names: Family Strengthening Intervention for Refugees;|
| No Intervention: FSI-R Control<br>Families randomized into the FSI-R Control arm will not receive the FSI-R treatment. Instead, they will continue with their usual care, referred to as Treatment as Usual (TAU). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in conflict via the Family Conflict Scale | The Family Conflict Scale utilizes a 7-point Likert Scale (0-6) to assess family conflict within the past month. Higher scores reflect greater family conflict. | T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2) | 
| Change in communication via the Revised Parent- Adolescent Communication Form | Utilizes a 5-point Likert scale (1-5) to assess parent-child communication. Greater scores indicate higher communication between parents and their children. | T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2) | 
| Change in family conflict via the Intergenerational Conflict Index | Utilizes a 5-point Likert scale (1-5) to assess intergenerational congruence across several domains of the parent-child relationship. Higher scores denote greater intergenerational congruence. | T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2) | 
| Change in parenting via the Alabama Parenting Questionnaire | 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. | T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in youth externalizing behaviors via the African Youth Psychosocial Assessment | This assessment utilizes a 4-point Likert scale (1-4) to assess for externalizing problems in youth with greater scores reflecting greater conduct problems. | T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2) | 
| Change in youth depression via the Center for Epidemiologic Studies-Depression scale | This measures utilizes a 4-point Likert scale (0-3) to assess depression in youth with higher scores indicated increasing levels of depression. The time frame referenced is during the past week. | T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
refugees, parental self-efficacy, family communication, family connectedness, refugee youth, youth functioning, integration