- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01868919
Triple P to Improve Behaviour in Children (TriplePChile)
May 30, 2013 updated by: Pontificia Universidad Catolica de Chile
Implementation Research of a Parenting Intervention to Improve Behaviour in Children in Primary Care
Joint research (quantitative and qualitative methodology) with quasi-experimental design, before-after without control group to evaluate the pilot implementation of Positive Parenting Program (Triple P) in the context of primary health care in Chile.
The hypothesis is that the program is feasible and acceptable to the Chilean population.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
General Purpose:
● Evaluate the pilot implementation of the Triple P program in the context of primary health care in Chile.
Specific Objectives:
- To assess the fidelity of implementation of the Triple P program
- Analyze the perception of participants, providers and organization on determinants of program implementation.
- Identify barriers and facilitators to plan future implementation of Triple P program in contexts similar to those in the study.
- To estimate the magnitude of change in children's behavior, emotional difficulties and rearing practices of caregivers before and after participation.
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Santiago, Chile
- Pontificia Universidad Católica de Chile
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parents or caregivers of children from 2 to 10 years old attending primary care clinic
- Parents or caregivers must be worried about child behaviour or their parenting skills and be willing to get professional help
Exclusion Criteria:
- Children: Pervasive Developmental Disorder, severe intellectual disability or severe psychopathology
- Caregivers: illiteracy, decompensated severe psychopathology or current psychotherapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Positive Parenting Program
Level 3 or 4 of Triple P
|
Level 3 or 4 of Triple P
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess implementability of the program in primary care in terms of feasibility, acceptability and level of participation
Time Frame: After one year of implementation
|
Instrument: focus groups
|
After one year of implementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of change in intensity of behaviour in children
Time Frame: After one year of implementation
|
Instrument: Eyberg Child Behaviour Inventory
|
After one year of implementation
|
|
Fidelity of program implementation
Time Frame: After one year of implementation
|
Supervision meetings and video recordings
|
After one year of implementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gladys Moreno, Dra., Pontificia Universidad Católica de Chile
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (ACTUAL)
May 1, 2013
Study Completion (ACTUAL)
May 1, 2013
Study Registration Dates
First Submitted
January 19, 2013
First Submitted That Met QC Criteria
May 30, 2013
First Posted (ESTIMATE)
June 5, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
June 5, 2013
Last Update Submitted That Met QC Criteria
May 30, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TRIPLEP.PUC.CHILE
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.