<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/NCT01668992</url>
  </required_header>
  <id_info>
    <org_study_id>21050</org_study_id>
    <nct_id>NCT01668992</nct_id>
  </id_info>
  <brief_title>Impact Evaluation of a Family-based Intervention With Burmese Migrant and Displaced Children and Families in Tak Province, Thailand</brief_title>
  <official_title>Impact Evaluation of a Family-based Intervention With Burmese Migrant and Displaced Children and Families in Tak Province, Thailand</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Rescue Committee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Agency for International Development (USAID)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Rescue Committee</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will evaluate the impact of a family-based intervention on the well-being of&#xD;
      Burmese migrant and displaced children and families living in Tak province, Thailand. The&#xD;
      methodology used in the impact evaluation study is a randomized waitlist controlled trial.&#xD;
&#xD;
      The study hypothesizes that participation in a family-based intervention will lead to&#xD;
      improved parenting practices and child and family outcomes, as follows.&#xD;
&#xD;
      Primary hypotheses:&#xD;
&#xD;
        1. Parents/caregivers participating in the family-based intervention will report increased&#xD;
           knowledge and use of positive parenting skills compared to control;&#xD;
&#xD;
        2. Parents/caregivers participating in the family-based intervention will report less use&#xD;
           of physical punishment and other harsh forms of discipline compared to control;&#xD;
&#xD;
        3. Parents/caregivers and children participating in the family-based intervention will&#xD;
           report higher levels of family functioning and cohesion compared to control.&#xD;
&#xD;
      Secondary hypotheses:&#xD;
&#xD;
        1. Parents/caregivers and children participating in the family-based intervention will&#xD;
           report lower levels of externalizing and internalizing child behaviors compared to&#xD;
           control;&#xD;
&#xD;
        2. Parents/caregivers and children participating in the family-based intervention will&#xD;
           report higher levels of child resilience and psychosocial well-being compared to&#xD;
           control;&#xD;
&#xD;
        3. Parents/caregivers participating in the family-based intervention will report lower&#xD;
           levels of alcohol use compared to control.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parenting practices</measure>
    <time_frame>One month and six months post-intervention</time_frame>
    <description>Changes in knowledge and use of positive parenting skills; change in use of physical punishment and other harsh forms of discipline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child psychosocial well-being</measure>
    <time_frame>One month and six months post-intervention</time_frame>
    <description>Changes in report of child externalizing and internalizing symptoms and resilience.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Family functioning and cohesion</measure>
    <time_frame>One month and six months post-intervention</time_frame>
    <description>Changes in levels of family communication, decision-making and relationships.</description>
  </other_outcome>
  <other_outcome>
    <measure>Alcohol use</measure>
    <time_frame>One month and six months post-intervention</time_frame>
    <description>Changes in adult alcohol use.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">992</enrollment>
  <condition>Parenting Practices</condition>
  <condition>Family Functioning</condition>
  <condition>Child Psychosocial Well-being</condition>
  <condition>Alcohol Use</condition>
  <arm_group>
    <arm_group_label>Family intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Families receive 12-week program on parenting skills, discipline methods and family communication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Families are on a waitlist and receive the intervention only after the trial is complete.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family intervention</intervention_name>
    <description>12-week parenting skills program for Burmese migrant and displaced children and families.</description>
    <arm_group_label>Family intervention</arm_group_label>
    <other_name>Happy Families Program</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Of Burmese origin&#xD;
&#xD;
          -  Currently living in one of 20 target communities in Tak province, Thailand&#xD;
&#xD;
          -  Primary caregiver to at least one child aged 8 to 12 years&#xD;
&#xD;
          -  Child aged 8 to 12 years&#xD;
&#xD;
          -  Participating in the family intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children living in orphanages, boarding houses, factories or other institutions&#xD;
&#xD;
          -  Persons with severe cognitive or physical disability who are impaired and unable to&#xD;
             understand and give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theresa S Betancourt, Sc.D., M.A.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard School of Public Health (HSPH)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeannie Annan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Rescue Committee</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Rescue Committee (IRC) Thailand</name>
      <address>
        <city>Mae Sot</city>
        <state>Tak</state>
        <zip>63110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>November 7, 2016</last_update_submitted>
  <last_update_submitted_qc>November 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parenting</keyword>
  <keyword>Discipline</keyword>
  <keyword>Family interventions</keyword>
  <keyword>Thailand</keyword>
  <keyword>Migration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <!-- 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/NCT01668992
org study id: 21050
nct id: NCT01668992
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The study will evaluate the impact of a family-based intervention on the well-being of
      Burmese migrant and displaced children and families living in Tak province, Thailand. The
      methodology used in the impact evaluation study is a randomized waitlist controlled trial.

      The study hypothesizes that participation in a family-based intervention will lead to
      improved parenting practices and child and family outcomes, as follows.

      Primary hypotheses:

        1. Parents/caregivers participating in the family-based intervention will report increased
           knowledge and use of positive parenting skills compared to control;

        2. Parents/caregivers participating in the family-based intervention will report less use
           of physical punishment and other harsh forms of discipline compared to control;

        3. Parents/caregivers and children participating in the family-based intervention will
           report higher levels of family functioning and cohesion compared to control.

      Secondary hypotheses:

        1. Parents/caregivers and children participating in the family-based intervention will
           report lower levels of externalizing and internalizing child behaviors compared to
           control;

        2. Parents/caregivers and children participating in the family-based intervention will
           report higher levels of child resilience and psychosocial well-being compared to
           control;

        3. Parents/caregivers participating in the family-based intervention will report lower
           levels of alcohol use compared to control.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Parenting practices
time frame: One month and six months post-intervention
description: Changes in knowledge and use of positive parenting skills; change in use of physical punishment and other harsh forms of discipline.
measure: Child psychosocial well-being
time frame: One month and six months post-intervention
description: Changes in report of child externalizing and internalizing symptoms and resilience.
measure: Family functioning and cohesion
time frame: One month and six months post-intervention
description: Changes in levels of family communication, decision-making and relationships.
measure: Alcohol use
time frame: One month and six months post-intervention
description: Changes in adult alcohol use.
arm group label: Family intervention
arm group type: Experimental
description: Families receive 12-week program on parenting skills, discipline methods and family communication.
arm group label: Waitlist control
arm group type: No Intervention
description: Families are on a waitlist and receive the intervention only after the trial is complete.
intervention type: Behavioral
intervention name: Family intervention
description: 12-week parenting skills program for Burmese migrant and displaced children and families.
arm group label: Family intervention
other name: Happy Families Program
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Theresa S Betancourt, Sc.D., M.A.
role: Principal Investigator
affiliation: Harvard School of Public Health (HSPH)
last name: Jeannie Annan, PhD
role: Principal Investigator
affiliation: International Rescue Committee
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Alcohol Drinking