- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01668992
Impact Evaluation of a Family-based Intervention With Burmese Migrant and Displaced Children and Families in Tak Province, Thailand
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:
- Parents/caregivers participating in the family-based intervention will report increased knowledge and use of positive parenting skills compared to control;
- Parents/caregivers participating in the family-based intervention will report less use of physical punishment and other harsh forms of discipline compared to control;
- Parents/caregivers and children participating in the family-based intervention will report higher levels of family functioning and cohesion compared to control.
Secondary hypotheses:
- Parents/caregivers and children participating in the family-based intervention will report lower levels of externalizing and internalizing child behaviors compared to control;
- Parents/caregivers and children participating in the family-based intervention will report higher levels of child resilience and psychosocial well-being compared to control;
- Parents/caregivers participating in the family-based intervention will report lower levels of alcohol use compared to control.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tak
-
Mae Sot, Tak, Thailand, 63110
- International Rescue Committee (IRC) Thailand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Of Burmese origin
- Currently living in one of 20 target communities in Tak province, Thailand
- Primary caregiver to at least one child aged 8 to 12 years
- Child aged 8 to 12 years
- Participating in the family intervention
Exclusion Criteria:
- Children living in orphanages, boarding houses, factories or other institutions
- Persons with severe cognitive or physical disability who are impaired and unable to understand and give informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Family intervention
Families receive 12-week program on parenting skills, discipline methods and family communication.
|
12-week parenting skills program for Burmese migrant and displaced children and families.
Other Names:
|
|
NO_INTERVENTION: Waitlist control
Families are on a waitlist and receive the intervention only after the trial is complete.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parenting practices
Time Frame: One month and six months post-intervention
|
Changes in knowledge and use of positive parenting skills; change in use of physical punishment and other harsh forms of discipline.
|
One month and six months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child psychosocial well-being
Time Frame: One month and six months post-intervention
|
Changes in report of child externalizing and internalizing symptoms and resilience.
|
One month and six months post-intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Family functioning and cohesion
Time Frame: One month and six months post-intervention
|
Changes in levels of family communication, decision-making and relationships.
|
One month and six months post-intervention
|
|
Alcohol use
Time Frame: One month and six months post-intervention
|
Changes in adult alcohol use.
|
One month and six months post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Theresa S Betancourt, Sc.D., M.A., Harvard School of Public Health (HSPH)
- Principal Investigator: Jeannie Annan, PhD, International Rescue Committee
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21050 (Other Identifier: City of Hope Medical Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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