- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04873310
Behavior Problems Prevention Using the Online Triple P Parenting Program (TriplePChile)
Behavior Problems Prevention Using the Online Triple P Parenting Program: Pilot Study of Acceptability and Feasibility
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Based on the importance that evidence-based parental interventions have acquired and the need from the health field to provide innovative alternatives that facilitate access to this type of services, parental support programs given through the web emerge. There is evidence that supports the idea that parenting programs taught through the web have an influence on reducing disruptive behaviors in children.
Triple P Online (TPOL) is an adaptation of the Positive Parenting Program, Triple P, a program that has been empirically tested. This adaptation is a parental intervention through the web with self-directed modality, which is based on Level 4 of the Triple P parental program and is configured in 8 interactive sessions with online modules. The topics covered are: 1) What is Positive Parenting, 2) Reinforcing the behavior we want, 3) Teaching new skills, 4) Managing negative behaviors, 5) Managing disobedience, 6) Preventing problems through planning, 7) Making fun outings, 8) Raising confident and competent children.
The main results observed in the implementation of the online Triple P program are (Sanders et al, 2012): reduction of problem child behavior, dysfunctional parenting styles, increasing parents' confidence in their parenting role, and reduction of parental anger.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Saray Ramirez
- Phone Number: +56988191548
- Email: saramirez1@miuandes.cl
Study Locations
-
-
Las Condes
-
Santiago, Las Condes, Chile, 7620001
- Recruiting
- Universidad de Los Andes
-
Contact:
- Saray Ramirez, BL
- Phone Number: +56988191548
- Email: saramirez1@miuandes.cl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Triple P online with professional support
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.
|
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
|
EXPERIMENTAL: Triple P online without professional support
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.
|
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.
|
NO_INTERVENTION: Control group
Control group without any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of the program by parents/main caregivers using the Acceptability Scale (AS)
Time Frame: Inmediately Post-intervention
|
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)
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parenting Scale (PS)
Time Frame: One month
|
This 30-item questionnaire measures three dysfunctional discipline styles: Laxness (permissive discipline), Over-reactivity (authoritarian discipline, anger, meanness and irritability) and Verbosity (long reprimands or reliance on talking).
The scale has good test-retest reliability (r = .83,
.82,
and .79,
respectively) and has been found to discriminate between parents of clinic and nonclinic children; and to correlate with observational measures of dysfunctional discipline.
Each item is answered in a scale of 7 points, according to what are the typical behavior parent perform under each scenario.
A total score is computed, ranging from 30 to 210.
A high score means parents are choosing more effective strategies to deal with different scenarios.
|
One month
|
Parenting Task Checklist (PTC)
Time Frame: One month
|
This checklist assesses parents' confidence in successfully dealing with 14 difficult child behaviors like whining and temper tantrums (Behavior Self-efficacy), and in dealing with difficult behavior in 14 different settings such as shopping and having visitors (Setting Self-efficacy).
|
One month
|
Alabama Parenting Questionnaire (APQ)
Time Frame: One month
|
The APQ measures five dimensions of parenting that are relevant to the etiology and treatment of child externalizing problems: (1) positive involvement with children, (2) supervision and monitoring, (3) use of positive discipline techniques, (4) consistency in the use of such discipline and (5) use of corporal punishment.
The project will use the dimensions (1), (3), and (4)., and it will not use the dimension of "(2) supervision and monitoring" because it is not relevant for the target population; and "(5) use of corporal punishment" because it is not the focus of the intervention.
The parent form will be used.
This questionnaire has 22 items.
Each statement is answered from 1= Never to 4 = Often.
The score ranges from 22 to 44. a High scores means better parenting skills.
|
One month
|
The Strengths and Difficulties Questionnaire (SDQ)
Time Frame: 2 months
|
The 25-item SDQ measures perceptions of prosocial and difficult behaviors in children aged 3-16 years. It has good test-retest reliability (r = .85) and has been found to discriminate well between low-risk and high-risk samples. Five scale scores are computed: Emotional Symptoms, Conduct Problems, Inattention/Hyperactivity, Peer Problems, and Prosocial Behavior. The first four sub-scales are included into one scleras of "Total Difficulties". Each item is answered from 0=Not true to 2=Certainly true. The score of each sub-scale ranges from 0 to 10. In the case of the Total Difficulties scale, Emotional symptoms sub-scale, Conduct Problems sub-scale, Inattention/Hyperactivity sub-scale, and Peer Problems sub-scale, a high score means more symptoms. In the cae of the Prosocial Behavior scale, a high score means stronger prosocial skills. |
2 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MLB-TripleP-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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