NCT04873310

Brief Summary

The Triple P program is a comprehensive system of parenting and family support of multilevel preventive intervention, developed for families with members up to 16 years of age, whose objective is to improve parenting skills and prevent or modify dysfunctional parenting practices, thus reducing Family risk factors that affect both child abuse, behavioral problems and emotional problems.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,920

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

1.7 years

First QC Date

April 21, 2021

Last Update Submit

October 29, 2021

Conditions

Keywords

programparental competencebehavior problemsemotional problems

Outcome Measures

Primary Outcomes (2)

  • Acceptability of the program by parents/main caregivers using the Acceptability Scale (AS)

    A questionnaire exploring the acceptability of the program will be answered by parents/main caregivers of students attending Grade 1 to Grade 4, Primary school, who will participate in the intervention. This questionnaire asks about the parents´opinions about the content of the intervention, strategies used, materials, and performance of the health professional helping in the intervention.The latter is only applicable for parents participating in "Group Triple-p online with professional support". The questionnaire also asks about satisfaction and the helpfulness of the program to improve parenting management. For each statement, the answers can go from 1=Strongly disagree to 5=Strongly agree. A high score means higher acceptably and satisfacción with the program. This is a questionnaire created by the research team.

    Inmediately Post-intervention

  • Feasibility of the program using the Feasibility Inventory (FI)

    A register will be used to determine the number of schools initially contacted and the number of schools that accepted to participate; number of parents/main caregivers contacted and that consented and assented to participate in the study at baseline and at follow-up; the number of sessions completed by parents in the platform, the number of telephone contacts delivered by the health professionals, the number of meeting over the phone conducted with parents. This Feasibility Inventory (FI) was created by the research team. This registry will not produce a score, rather it will provide indicators to achievements for several areas of the implementation of the program.

    6 months

Secondary Outcomes (4)

  • Parenting Scale (PS)

    One month

  • Parenting Task Checklist (PTC)

    One month

  • Alabama Parenting Questionnaire (APQ)

    One month

  • The Strengths and Difficulties Questionnaire (SDQ)

    2 months

Study Arms (3)

Triple P online with professional support

EXPERIMENTAL

In the online version with professional support, the psychologist in charge will have the role of monitoring the autonomous work of the participants during the 8 sessions, as well as answering questions and doubts that the participants may have regarding the program and its implementation.

Other: Triple P online with professional support

Triple P online without professional support

EXPERIMENTAL

In the version without professional support, the role of the psychologist in charge will be to keep the platform updated so that the person who self-administers the intervention does not have technical problems associated with the platform.

Other: Triple P online without professional support

Control group

NO INTERVENTION

Control group without any intervention.

Interventions

The psychologist in charge will have the role of monitoring the autonomous work of the participants during the 8 sessions. The psychologist in charge will also verify that the participants are able to complete the online modules week by week, that they understand the contents taught in the module and that they are practicing the tasks and exercises assigned in each of the modules; in addition to generating an action plan in case the participants are not adhering week by week to the self-administration of the program. The follow-up and contact with the families will be carried out by phone and through a weekly email-type messaging system, implemented within the same platform on which the program material is found

Triple P online with professional support

The role of the psychologist in charge will be to keep the platform updated so that the person who self-administers the intervention does not have technical problems associated with the platform.

Triple P online without professional support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Belong to one of the three socio-economic levels according to SIMCE classification (High, Medium and Low).
  • Attend to a primary school of the Municipality of Lo Barnechea, Santiago, Chile.
  • Previous participation in the instruments validations stages.
  • Identification in The Strengths and Difficulties Questionnaire (SDQ) with behavior problems above the 80th percentile.
  • Have Internet access.

You may not qualify if:

  • Attend to a school that is developing or implementing a manualized program for parents associated with the prevention of behavioral problems
  • Participating in a similar study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de los Andes

Santiago, Las Condes, 7620001, Chile

RECRUITING

Related Publications (4)

  • Sanders MR, Baker S, Turner KM. A randomized controlled trial evaluating the efficacy of Triple P Online with parents of children with early-onset conduct problems. Behav Res Ther. 2012 Nov;50(11):675-84. doi: 10.1016/j.brat.2012.07.004. Epub 2012 Aug 18.

  • Arnold DS, O'Leary SG, Wolff LS, Acker MM. The Parenting Scale: A measure of dysfunctional parenting in discipline situations. Psychological Assessment. 1993; 5(2), 137-144. https://doi.org/10.1037/1040-3590.5.2.137

    RESULT
  • Goodman R, Scott S. Comparing the Strengths and Difficulties Questionnaire and the Child Behavior Checklist: is small beautiful? J Abnorm Child Psychol. 1999 Feb;27(1):17-24. doi: 10.1023/a:1022658222914.

  • Sanders MR, Woolley ML. The relationship between maternal self-efficacy and parenting practices: implications for parent training. Child Care Health Dev. 2005 Jan;31(1):65-73. doi: 10.1111/j.1365-2214.2005.00487.x.

MeSH Terms

Conditions

Mental Disorders

Central Study Contacts

Jorge Gaete, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
In all the assessments, the principal investigator and research assistants will be blind to the trial arm where the schools/students were allocated
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 21, 2021

First Posted

May 5, 2021

Study Start

April 6, 2021

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations