Addressing Mental Health Disparities in Refugee Children

Boston College

Status: Completed

Conditions: Family Research

Treatments: Behavioral: FSI-R Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03796065

18.251.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 354 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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354 participants in 2 patient groups

FSI-R Treatment

Experimental group

Description:

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.

Treatment:

Behavioral: FSI-R Treatment

FSI-R Control

No Intervention group

Description:

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).