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Completed

NCT Number: NCT03796065

Addressing Mental Health Disparities in Refugee Children

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.

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Key information

Conditions

Family Research

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maine Immigrant and Refugee Services, Lewiston, Maine, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Family Strengthening Intervention for Refugees

Primary outcomes

  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 outcomes

  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".

Sponsors and collaborators

Lead sponsor

Boston College

Other

Registry information

Official study title

Addressing Mental Health Disparities in Refugee Children Through Family and Community-based Prevention: A CBPR Collaboration and Hybrid Implementation Effectiveness Trial

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 8, 2019
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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