Addressing Mental Health Disparities in Refugee Children

NCT ID: NCT03796065

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-27
• Study Completion Date: 2022-06-30

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.

Conditions

Family Research

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

FSI-R Treatment

Intervention Type: BEHAVIORAL

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.

FSI-R Control

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FSI-R Treatment

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Family Strengthening Intervention for Refugees

Eligibility Criteria

Inclusion Criteria

• being a resettled refugee family
• having one or more school-aged children living in the home (aged 7-17)

• 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

• families in the midst of a crisis (e.g. active suicide attempts)

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theresa Betancourt, ScD

Role: PRINCIPAL_INVESTIGATOR

Boston College

Locations

Maine Immigrant and Refugee Services

Lewiston, Maine, United States

Jewish Family Service

Springfield, Massachusetts, United States

Countries

United States

References

Jung E, Black C, Placencio-Castro M, Chamlagai L, Osman R, Hoffman M, Beardslee W, Betancourt TS. Delivering a family-based child mental health promotion program among two resettled refugee communities during the COVID-19 pandemic: Lessons learned in a hybrid type II implementation-effectiveness randomized controlled trial. Am J Community Psychol. 2025 Oct 5. doi: 10.1002/ajcp.70021. Online ahead of print.

Reference Type: DERIVED

PMID: 41046558 (View on PubMed)

Other Identifiers

18.251.01

Identifier Type: -

Identifier Source: org_study_id