<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03796065</url>
  </required_header>
  <id_info>
    <org_study_id>18.251.01</org_study_id>
    <nct_id>NCT03796065</nct_id>
  </id_info>
  <brief_title>Addressing Mental Health Disparities in Refugee Children</brief_title>
  <official_title>Addressing Mental Health Disparities in Refugee Children Through Family and Community-based Prevention: A CBPR Collaboration and Hybrid Implementation Effectiveness Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study will employ a cross-cultural Community Based Participatory Research (CBPR)&#xD;
      approach to build from prior needs assessments and mixed-methods research to evaluate the&#xD;
      effectiveness of the Family Strengthening Intervention for Refugees (FSI-R), a preventative&#xD;
      family home-based visiting intervention intended to mitigate mental health disparities among&#xD;
      refugee children and families using a hybrid implementation-effectiveness design. Results of&#xD;
      the investigator's trial will expand the evidence-base on community-based interventions for&#xD;
      refugees and has the potential to be replicated to reduce mental health disparities affecting&#xD;
      diverse groups of refugee children and families.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using a CBPR approach, a family based prevention model, the Family Strengthening Intervention&#xD;
      for Refugees (FSI-R) was adapted from a tested model used in Africa and designed for delivery&#xD;
      by refugee community health workers with through a process involving stakeholder consultation&#xD;
      and local refugee Community Advisory Board input. Pilot data on the FSI-R demonstrates strong&#xD;
      feasibility and acceptability, but further data are needed on effectiveness as well as&#xD;
      barriers and facilitators to implementation by community health workers embedded in&#xD;
      refugee-serving social services agencies. Specific aims are to (1) examine the impact of a&#xD;
      family-based preventive intervention on outcomes of parent-child relationships, family&#xD;
      functioning, and child mental health using a Hybrid Type 2 Effectiveness-Implementation&#xD;
      Design (families with children aged 7-17 in a two-arm randomized controlled trial); (2)&#xD;
      identify barriers and facilitators to implementation of the FSI-R by community health workers&#xD;
      by conducting a process evaluation concurrent with the delivery of the intervention; and (3)&#xD;
      strengthen the science of community engagement to address health disparities by fortifying&#xD;
      CBPR-based pathways of change via collaborative partnerships between refugee communities,&#xD;
      service providers, and academic stakeholders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 27, 2018</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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).</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in conflict via the Family Conflict Scale</measure>
    <time_frame>T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in communication via the Revised Parent- Adolescent Communication Form</measure>
    <time_frame>T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)</time_frame>
    <description>Utilizes a 5-point Likert scale (1-5) to assess parent-child communication. Greater scores indicate higher communication between parents and their children.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in family conflict via the Intergenerational Conflict Index</measure>
    <time_frame>T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in parenting via the Alabama Parenting Questionnaire</measure>
    <time_frame>T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in youth externalizing behaviors via the African Youth Psychosocial Assessment</measure>
    <time_frame>T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)</time_frame>
    <description>This assessment utilizes a 4-point Likert scale (1-4) to assess for externalizing problems in youth with greater scores reflecting greater conduct problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in youth depression via the Center for Epidemiologic Studies-Depression scale</measure>
    <time_frame>T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)</time_frame>
    <description>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 &quot;during the past week&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">354</enrollment>
  <condition>Family Research</condition>
  <arm_group>
    <arm_group_label>FSI-R Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FSI-R Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FSI-R Treatment</intervention_name>
    <description>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.</description>
    <arm_group_label>FSI-R Treatment</arm_group_label>
    <other_name>Family Strengthening Intervention for Refugees</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for families:&#xD;
&#xD;
          -  being a resettled refugee family&#xD;
&#xD;
          -  having one or more school-aged children living in the home (aged 7-17)&#xD;
&#xD;
        Inclusion Criteria for parents/caregivers:&#xD;
&#xD;
          -  be aged 18 or older&#xD;
&#xD;
          -  cares for and lives in the same household of the children at least 50% of the time&#xD;
&#xD;
          -  is the child'd legal guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not meeting the above inclusion criteria&#xD;
&#xD;
          -  families in the midst of a crisis (e.g. active suicide attempts)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theresa Betancourt, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maine Immigrant and Refugee Services</name>
      <address>
        <city>Lewiston</city>
        <state>Maine</state>
        <zip>04240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish Family Service</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>refugees</keyword>
  <keyword>parental self-efficacy</keyword>
  <keyword>family communication</keyword>
  <keyword>family connectedness</keyword>
  <keyword>refugee youth</keyword>
  <keyword>youth functioning</keyword>
  <keyword>integration</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03796065
org study id: 18.251.01
nct id: NCT03796065
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
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).
primary purpose: Prevention
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.
measure: 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)
description: 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.
measure: 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)
description: Utilizes a 5-point Likert scale (1-5) to assess parent-child communication. Greater scores indicate higher communication between parents and their children.
measure: 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)
description: 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.
measure: 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)
description: 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.
measure: 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)
description: This assessment utilizes a 4-point Likert scale (1-4) to assess for externalizing problems in youth with greater scores reflecting greater conduct problems.
measure: 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)
description: 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".
arm group label: FSI-R Treatment
arm group type: Experimental
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.
arm group label: FSI-R Control
arm group type: No Intervention
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).
intervention type: Behavioral
intervention name: FSI-R Treatment
description: 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.
arm group label: FSI-R Treatment
other name: Family Strengthening Intervention for Refugees
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: No
last name: Theresa Betancourt, ScD
role: Principal Investigator
affiliation: Boston College
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided