NCT01668992

Brief 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. 1.Parents/caregivers participating in the family-based intervention will report increased knowledge and use of positive parenting skills compared to control;
  2. 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. 3.Parents/caregivers and children participating in the family-based intervention will report higher levels of family functioning and cohesion compared to control.
  4. 4.Parents/caregivers and children participating in the family-based intervention will report lower levels of externalizing and internalizing child behaviors compared to control;
  5. 5.Parents/caregivers and children participating in the family-based intervention will report higher levels of child resilience and psychosocial well-being compared to control;
  6. 6.Parents/caregivers participating in the family-based intervention will report lower levels of alcohol use compared to control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
992

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

August 16, 2012

Last Update Submit

November 7, 2016

Conditions

Parenting PracticesFamily FunctioningChild Psychosocial Well-beingAlcohol Use

Keywords

ParentingDisciplineFamily interventionsThailandMigration

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Child psychosocial well-being

    One month and six months post-intervention

Other Outcomes (2)

  • Family functioning and cohesion

    One month and six months post-intervention

  • Alcohol use

    One month and six months post-intervention

Study Arms (2)

Family intervention

EXPERIMENTAL

Families receive 12-week program on parenting skills, discipline methods and family communication.

Behavioral: Family intervention

Waitlist control

NO INTERVENTION

Families are on a waitlist and receive the intervention only after the trial is complete.

Interventions

Family interventionBEHAVIORAL

12-week parenting skills program for Burmese migrant and displaced children and families.

Also known as: Happy Families Program
Family intervention

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Rescue Committee (IRC) Thailand

Mae Sot, Changwat Tak, 63110, Thailand

Location

Related Publications (1)

  • Puffer ES, Annan J, Sim AL, Salhi C, Betancourt TS. The impact of a family skills training intervention among Burmese migrant families in Thailand: A randomized controlled trial. PLoS One. 2017 Mar 28;12(3):e0172611. doi: 10.1371/journal.pone.0172611. eCollection 2017.

    PMID: 28350809DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Theresa S Betancourt, Sc.D., M.A.

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

  • Jeannie Annan, PhD

    International Rescue Committee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2012

First Posted

August 20, 2012

Study Start

September 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 9, 2016

Record last verified: 2016-11

Locations

TH(1)