Viewing Study NCT01771068


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Study NCT ID: NCT01771068
Status: COMPLETED
Last Update Posted: 2013-01-18
First Post: 2013-01-11
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Trial of a Parenting Discussion Group in Panama, Central America
Sponsor: University of Manchester
Organization:

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2013-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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).
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 Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: