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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01771068
Other study ID # PTY12
Secondary ID
Status Completed
Phase N/A
First received January 11, 2013
Last updated January 17, 2013
Start date April 2012
Est. completion date December 2012

Study information

Verified date January 2013
Source University of Manchester
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Triple P Positive Parenting Program Discussion Group "Dealing with Disobedience"


Locations

Country Name City State
Panama Ministry of Education, District of Panama Panama

Sponsors (2)

Lead Sponsor Collaborator
University of Manchester National Secretariat of Science, Technology and Innovation in Panama (SENACYT)

Country where clinical trial is conducted

Panama, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Eyberg Child Behaviour Inventory (ECBI) baseline, 2 weeks post intervention, 3 months and 6 months No
Secondary Change in Depression Anxiety Stress Scale 21 (DASS 21) baseline, 2 weeks post intervention, 3 months and 6 months No
Secondary Change in Parenting Scale (PS) baseline, 2 weeks post intervention, 3 months and 6 months No
Secondary Change in Parenting Task Checklist (PTC) baseline, 2 weeks post intervention, 3 months and 6 months No
See also
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Completed NCT04633434 - Evaluation Study of Talk Parenting Skills N/A
Recruiting NCT05802160 - The Good Start Matters - Parenting Program N/A