Addressing Mental Health Disparities in Refugee Children

Not Applicable

Completed

• Conditions: Family Research
• Interventions: Behavioral: FSI-R Treatment

• Registration Number: NCT03796065
• Lead Sponsor: Boston College

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.

Study Timeline

• Study Start: 2018-08-27
• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-08
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

Not provided

Exclusion Criteria

• not meeting the above inclusion criteria
• families in the midst of a crisis (e.g. active suicide attempts)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FSI-R Treatment	FSI-R Treatment	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.

Primary Outcome Measures

Name	Time	Method
Change in family conflict via the Intergenerational Conflict Index	T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)	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.
Change in conflict via the Family Conflict Scale	T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)	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.
Change in communication via the Revised Parent- Adolescent Communication Form	T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)	Utilizes a 5-point Likert scale (1-5) to assess parent-child communication. Greater scores indicate higher communication between parents and their children.
Change in parenting via the Alabama Parenting Questionnaire	T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)	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.

Secondary Outcome Measures

Name	Time	Method
Change in youth externalizing behaviors via the African Youth Psychosocial Assessment	T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)	This assessment utilizes a 4-point Likert scale (1-4) to assess for externalizing problems in youth with greater scores reflecting greater conduct problems.
Change in youth depression via the Center for Epidemiologic Studies-Depression scale	T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)	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".

Trial Locations

Locations (2)

Maine Immigrant and Refugee Services; 🇺🇸 Lewiston, Maine, United States

Jewish Family Service; 🇺🇸 Springfield, Massachusetts, United States