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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01668992
Other study ID # 21050
Secondary ID
Status Completed
Phase N/A
First received August 16, 2012
Last updated November 7, 2016
Start date September 2011
Est. completion date May 2013

Study information

Verified date November 2016
Source International Rescue Committee
Contact n/a
Is FDA regulated No
Health authority Thailand: Ministry of Public Health
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 992
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Intervention

Behavioral:
Family intervention
12-week parenting skills program for Burmese migrant and displaced children and families.

Locations

Country Name City State
Thailand International Rescue Committee (IRC) Thailand Mae Sot Tak

Sponsors (4)

Lead Sponsor Collaborator
International Rescue Committee Duke University, Harvard School of Public Health, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Other Family functioning and cohesion Changes in levels of family communication, decision-making and relationships. One month and six months post-intervention No
Other Alcohol use Changes in adult alcohol use. One month and six months post-intervention No
Primary Parenting practices 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 No
Secondary Child psychosocial well-being Changes in report of child externalizing and internalizing symptoms and resilience. One month and six months post-intervention No
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