Addressing Mental Health Disparities in Refugee Children

Not Applicable

Completed

• Conditions: Family Research

• 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

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