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Trial record 36 of 277 for:    Panama

Trial of a Parenting Discussion Group in Panama, Central America

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ClinicalTrials.gov Identifier: NCT01771068
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : January 18, 2013
Sponsor:
Collaborator:
National Secretariat of Science, Technology and Innovation in Panama (SENACYT)
Information provided by (Responsible Party):
Anilena Mejia, University of Manchester

Tracking Information
First Submitted Date  ICMJE January 11, 2013
First Posted Date  ICMJE January 18, 2013
Last Update Posted Date January 18, 2013
Study Start Date  ICMJE April 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2013)
Change in Eyberg Child Behaviour Inventory (ECBI) [ Time Frame: baseline, 2 weeks post intervention, 3 months and 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2013)
  • Change in Depression Anxiety Stress Scale 21 (DASS 21) [ Time Frame: 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 ]
  • Change in Parenting Task Checklist (PTC) [ Time Frame: baseline, 2 weeks post intervention, 3 months and 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of a Parenting Discussion Group in Panama, Central America
Official Title  ICMJE Not Provided
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Child Behavioural and Emotional Difficulties
  • Parenting Practices
Intervention  ICMJE Behavioral: Triple P Positive Parenting Program Discussion Group "Dealing with Disobedience"
Study Arms  ICMJE
  • No Intervention: Waiting list
  • 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.
    Intervention: Behavioral: Triple P Positive Parenting Program Discussion Group "Dealing with Disobedience"
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2013)
108
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01771068
Other Study ID Numbers  ICMJE PTY12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anilena Mejia, University of Manchester
Study Sponsor  ICMJE University of Manchester
Collaborators  ICMJE National Secretariat of Science, Technology and Innovation in Panama (SENACYT)
Investigators  ICMJE
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
PRS Account University of Manchester
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP