Addressing Mental Health Disparities in Refugee Children

NCT03796065 | Completed

• 1 other identifier: 18.251.01
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 2

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.

Conditions

Family Research

Keywords

refugees; parental self-efficacy; family communication; family connectedness; refugee youth; youth functioning; integration

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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)

• 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)

Study Arms (2)

FSI-R Treatment

EXPERIMENTAL

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

FSI-R Control

NO INTERVENTION

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).

Interventions

FSI-R Treatment 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.

Also known as: Family Strengthening Intervention for Refugees

FSI-R Treatment

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston College: lead

Study Sites (2)

Maine Immigrant and Refugee Services

Lewiston, Maine, 04240, United States

Location

Jewish Family Service

Springfield, Massachusetts, 01108, United States

Location

Related Publications (1)

• 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.

  PMID: 41046558 DERIVED

Study Officials

• Theresa Betancourt, ScD

  Boston College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The Research Assistants (RAs) who will collect both qualitative and quantitative data will be blind to the condition in which study participants are randomized.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 8, 2019
• Study Start: August 27, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

US (2)