- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01771068
Trial of a Parenting Discussion Group in Panama, Central America
The present study aims to examine the effectiveness of a parenting intervention, the Triple P Positive Parenting Program Level 3 discussion groups "dealing with disobedience". Triple P is a system of interventions to support families and was developed at the University of Queensland in Australia in the 1980's. As few studies have tested the effectiveness of parenting programs in developing countries, the present study took place in a developing country, Panama.
In a recent study carried out in Australia, this same intervention was found effective in reducing child behaviour problems and the use of dysfunctional parenting (Morawska, Haslam, Milne & Sanders, 2011).
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a randomized controlled trial (RCT) with two groups (waiting list versus Triple P discussion groups) and measurements at pre-intervention, post intervention, three and six months follow up.
The intervention trialed was a 2-hour, one-session discussion group on child noncompliance. Groups were composed by a maximum of 10 parents and were facilitated by the principal researcher, who is an accredited practitioner. The groups were interactive and discussion based, and a power point presentation with embedded-video clips were used to aid the facilitator. The key points that were covered in the discussion group included reasons for disobedience, parenting traps, encouraging good behaviour, and managing disobedience. Parents also received a workbook that included the content covered in the discussion group and 2 follow up telephone calls to check how they were doing after.
Participants were randomly assigned to a treatment group (Triple P discussion groups) or to a waiting list group. A statistician independent from the research team generated a random list of numbers. Randomization was stratified based on the level of child behavioural difficulties (high or low) measured at baseline. In order to ensure allocation concealment, sequentially-numbered, opaque, sealed envelopes (SNOSE) were opened after participants agreed to take part in the study and completed a baseline assessment. After randomization, those assigned to the waiting list group were assessed at time 1 (baseline) and then 4 weeks, 3 months and 6 months after the first assessment. Those assigned to the treatment group were assessed at time 1 (baseline), 2 weeks, 3 months and 6 months after the intervention. Assessments were carried out by a research assistant who was blind to group allocation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Panama, Panama
- Ministry of Education, District of Panama
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants must be Panamanian
- must have at least one child between 3 and 12 years old
- must report some level of difficulty in dealing with their child behaviour.
Exclusion Criteria:
- no report of difficulty in dealing with child behaviour
- illiteracy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Waiting list
|
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Experimental: Parenting Discussion Group
Two-hour discussion group on child noncompliance.
Groups were composed by a maximum of 10 parents and were facilitated by the principal researcher, who is an accredited practitioner.
The groups were interactive and discussion based, and a power point presentation with embedded-video clips was used to aid the facilitator.
The key points covered in the discussion group included reasons for disobedience, parenting traps, encouraging good behaviour, and managing disobedience.
Parents also received a workbook that included the content covered in the discussion group and 2 follow up telephone calls to check how they were doing after the discussion groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Eyberg Child Behaviour Inventory (ECBI)
Time Frame: baseline, 2 weeks post intervention, 3 months and 6 months
|
baseline, 2 weeks post intervention, 3 months and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Depression Anxiety Stress Scale 21 (DASS 21)
Time Frame: baseline, 2 weeks post intervention, 3 months and 6 months
|
baseline, 2 weeks post intervention, 3 months and 6 months
|
|
Change in Parenting Scale (PS)
Time Frame: baseline, 2 weeks post intervention, 3 months and 6 months
|
baseline, 2 weeks post intervention, 3 months and 6 months
|
|
Change in Parenting Task Checklist (PTC)
Time Frame: baseline, 2 weeks post intervention, 3 months and 6 months
|
baseline, 2 weeks post intervention, 3 months and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anilena Mejia, MSc, The University of Manchester
- Principal Investigator: Rachel Calam, Professor, The University of Manchester
- Principal Investigator: Matthew Sanders, Professor, The University of Queensland
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
Other Study ID Numbers
- PTY12
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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