Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT01668992
Status:
COMPLETED
Last Update Posted:
2016-11-09
First Post:
2012-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact Evaluation of a Family-based Intervention With Burmese Migrant and Displaced Children and Families in Tak Province, Thailand
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 992}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-07', 'studyFirstSubmitDate': '2012-08-16', 'studyFirstSubmitQcDate': '2012-08-16', 'lastUpdatePostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Family functioning and cohesion', 'timeFrame': 'One month and six months post-intervention', 'description': 'Changes in levels of family communication, decision-making and relationships.'}, {'measure': 'Alcohol use', 'timeFrame': 'One month and six months post-intervention', 'description': 'Changes in adult alcohol use.'}], 'primaryOutcomes': [{'measure': 'Parenting practices', 'timeFrame': '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.'}], 'secondaryOutcomes': [{'measure': 'Child psychosocial well-being', 'timeFrame': 'One month and six months post-intervention', 'description': 'Changes in report of child externalizing and internalizing symptoms and resilience.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parenting', 'Discipline', 'Family interventions', 'Thailand', 'Migration'], 'conditions': ['Parenting Practices', 'Family Functioning', 'Child Psychosocial Well-being', 'Alcohol Use']}, 'referencesModule': {'references': [{'pmid': '28350809', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe study hypothesizes that participation in a family-based intervention will lead to improved parenting practices and child and family outcomes, as follows.\n\nPrimary hypotheses:\n\n1. Parents/caregivers participating in the family-based intervention will report increased knowledge and use of positive parenting skills compared to control;\n2. Parents/caregivers participating in the family-based intervention will report less use of physical punishment and other harsh forms of discipline compared to control;\n3. Parents/caregivers and children participating in the family-based intervention will report higher levels of family functioning and cohesion compared to control.\n\nSecondary hypotheses:\n\n1. Parents/caregivers and children participating in the family-based intervention will report lower levels of externalizing and internalizing child behaviors compared to control;\n2. Parents/caregivers and children participating in the family-based intervention will report higher levels of child resilience and psychosocial well-being compared to control;\n3. Parents/caregivers participating in the family-based intervention will report lower levels of alcohol use compared to control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Of Burmese origin\n* Currently living in one of 20 target communities in Tak province, Thailand\n* Primary caregiver to at least one child aged 8 to 12 years\n* Child aged 8 to 12 years\n* Participating in the family intervention\n\nExclusion Criteria:\n\n* Children living in orphanages, boarding houses, factories or other institutions\n* Persons with severe cognitive or physical disability who are impaired and unable to understand and give informed consent'}, 'identificationModule': {'nctId': 'NCT01668992', 'briefTitle': 'Impact Evaluation of a Family-based Intervention With Burmese Migrant and Displaced Children and Families in Tak Province, Thailand', 'organization': {'class': 'OTHER', 'fullName': 'International Rescue Committee'}, 'officialTitle': 'Impact Evaluation of a Family-based Intervention With Burmese Migrant and Displaced Children and Families in Tak Province, Thailand', 'orgStudyIdInfo': {'id': '21050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Family intervention', 'description': 'Families receive 12-week program on parenting skills, discipline methods and family communication.', 'interventionNames': ['Behavioral: Family intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control', 'description': 'Families are on a waitlist and receive the intervention only after the trial is complete.'}], 'interventions': [{'name': 'Family intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Happy Families Program'], 'description': '12-week parenting skills program for Burmese migrant and displaced children and families.', 'armGroupLabels': ['Family intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'Mae Sot', 'state': 'Changwat Tak', 'country': 'Thailand', 'facility': 'International Rescue Committee (IRC) Thailand', 'geoPoint': {'lat': 16.71667, 'lon': 98.56667}}], 'overallOfficials': [{'name': 'Theresa S Betancourt, Sc.D., M.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}, {'name': 'Jeannie Annan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Rescue Committee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Rescue Committee', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, {'name': 'Duke University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}