Triple P to Improve Behaviour in Children | NCT01868919

Studies
Triple P to Improve Behaviour in Children

NCT01868919

Sponsor

Pontificia Universidad Catolica de Chile

Status

Completed

Last Update Posted

Jun 5, 2013Estimated

Enrollment

87Actual

Phase

Not Applicable

Conditions

Parenting
Child Behaviour
Mental Health Wellness 1
Family Research

Interventions

Positive Parenting Program

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Jan 19, 2013

First Submission Date that Met QC Criteria

May 30, 2013

First Posted Date

Jun 5, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2013

Last Update Posted Date

Jun 5, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Positive Parenting Program	Experimental	Level 3 or 4 of Triple P	Behavioral: Positive Parenting Program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Positive Parenting Program	Behavioral	Level 3 or 4 of Triple P	Positive Parenting Program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess implementability of the program in primary care in terms of feasibility, acceptability and level of participation	Instrument: focus groups	After one year of implementation

Secondary Outcomes

Measure	Description	Time Frame
Percentage of change in intensity of behaviour in children	Instrument: Eyberg Child Behaviour Inventory	After one year of implementation
Fidelity of program implementation	Supervision meetings and video recordings

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gladys Moreno, Dra.	Pontificia Universidad Catolica de Chile	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pontificia Universidad Católica de Chile		Santiago	Santiago Metropolitan		Chile

References Module

Citations

Not provided

Label	URL
Triple P Chilean website	View source
Triple P Official Website	View source
Triple P Provider Network