Parenting PracticesNCT01668992
Impact Evaluation of a Family-based Intervention With Burmese Migrant and Displaced Children and Families in Tak Province, Thailand
A study testing Family intervention in people with Parenting Practices and Family Functioning, run by International Rescue Committee at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting Practices, Family Functioning, Child Psychosocial Well-being
- What is being tested?
- Family intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 992 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2011to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
International Rescue Committee (IRC) Thailand
Mae Sot, Changwat Tak, 63110
About this study
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.
Read more
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.
- Being tested
- Family intervention
- Keywords
- Parenting, Discipline, Family interventions, Thailand, Migration
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family interventionBehavioural
Also called Happy Families Program
12-week parenting skills program for Burmese migrant and displaced children and families.
| Study group | Role | What they receive |
|---|---|---|
| Family intervention | Experimental | Families receive 12-week program on parenting skills, discipline methods and family communication. Receives: Behavioral: Family intervention |
| Waitlist control | No intervention | Families are on a waitlist and receive the intervention only after the trial is complete. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting practices
Changes in knowledge and use of positive parenting skills; change in use of physical punishment and other harsh forms of discipline.
Measured: One month and six months post-intervention
Secondary outcomes (1)
Child psychosocial well-being
Changes in report of child externalizing and internalizing symptoms and resilience.
Measured: One month and six months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parenting PracticesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 992 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Rescue Committee
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Harvard School of Public Health (HSPH), Duke University
- Responsible party
- Sponsor
- Investigators
- Theresa S Betancourt, Sc.D., M.A., Principal investigator, Harvard School of Public Health (HSPH)Jeannie Annan, PhD, Principal investigator, International Rescue Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668992
- Sponsor's protocol ID
- 21050
- Status last verified
- Nov 2016
- First submitted
- 16 Aug 2012
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28350809
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of a Family-based Intervention With Burmese Migrant and Displaced Children and Families in Tak Province, Thailand
- ClinicalTrials.gov ID
- NCT01668992
- Acronym / sponsor ID
- 21050
- Keywords
- Parenting, Discipline, Family interventions, Thailand, Migration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 992 participants (actual)
- Lead sponsor
- International Rescue CommitteeUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Harvard School of Public Health (HSPH), Duke University
- Study start
- Sep 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family intervention | Experimental | Behavioral: Family interventionFamilies receive 12-week program on parenting skills, discipline methods and family communication. |
| Waitlist control | No intervention | –Families are on a waitlist and receive the intervention only after the trial is complete. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family interventionAlso: Happy Families Program12-week parenting skills program for Burmese migrant and displaced children and families. | Behavioural | Family intervention |
Primary outcome
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.
1 secondary outcome
Child psychosocial well-being
Time frame: One month and six months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
- Derived from this study: PubMed 28350809Puffer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa S Betancourt, Sc.D., M.A. principal investigator
Harvard School of Public Health (HSPH)
Jeannie Annan, PhD principal investigator
International Rescue Committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family intervention in people with Parenting Practices and Family Functioning, run by International Rescue Committee at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting practices (time frame: One month and six months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01668992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.