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Addressing Mental Health Disparities in Refugee Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03796065
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 23, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Family Research Behavioral: FSI-R Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Single (Care Provider)
Masking Description: The Research Assistants (RAs) who will collect both qualitative and quantitative data will be blind to the condition in which study participants are randomized.
Primary Purpose: Prevention
Official Title: Addressing Mental Health Disparities in Refugee Children Through Family and Community-based Prevention: A CBPR Collaboration and Hybrid Implementation Effectiveness Trial
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.
Other Name: Family Strengthening Intervention for Refugees

No Intervention: 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).

Primary Outcome Measures :
  1. Change in conflict via the Family Conflict Scale [ Time Frame: 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.

  2. Change in communication via the Revised Parent- Adolescent Communication Form [ Time Frame: 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.

  3. Change in family conflict via the Intergenerational Conflict Index [ Time Frame: 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.

  4. Change in parenting via the Alabama Parenting Questionnaire [ Time Frame: 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 :
  1. Change in youth externalizing behaviors via the African Youth Psychosocial Assessment [ Time Frame: 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.

  2. Change in youth depression via the Center for Epidemiologic Studies-Depression scale [ Time Frame: 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".

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03796065

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Contact: Jordan Farrar, PhD 617-552-8397
Contact: Jenna Berent, MPH 585-766-0507

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United States, Maine
Maine Immigrant and Refugee Services Recruiting
Lewiston, Maine, United States, 04240
Contact: Rilwan Osman, MSW    207-753-2700 ext 101   
United States, Massachusetts
Jewish Family Service Recruiting
Springfield, Massachusetts, United States, 01108
Contact: Saad Abdulijabbar, MEd    413-737-2601   
Sponsors and Collaborators
Boston College
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Principal Investigator: Theresa Betancourt, ScD Boston College
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Responsible Party: Boston College Identifier: NCT03796065    
Other Study ID Numbers: 18.251.01
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston College:
parental self-efficacy
family communication
family connectedness
refugee youth
youth functioning