ParentingTriplePChileNCT04873310
Behavior Problems Prevention Using the Online Triple P Parenting Program
A study testing Triple P online with professional support and Triple P online without professional support in people with Parenting, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting
- What is being tested?
- Triple P online with professional support and Triple P online without professional support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,920 participants
- Where
- 1 siteChile
- Study dates
- 6 Apr 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Universidad de los Andes
Santiago, Las Condes, 7620001
Jorge Gaete, PhD, +56940245650, jgaete@uandes.cl
Saray Ramirez, BL, +56988191548, saramirez1@miuandes.cl
About this study
Official title: Behavior Problems Prevention Using the Online Triple P Parenting Program: Pilot Study of Acceptability and Feasibility
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.
Read the 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.
- Conditions
- Parenting
- Being tested
- Triple P online with professional support, Triple P online without professional support
- Keywords
- program, parental competence, behavior problems, emotional problems
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple P online with professional supportOther
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 without professional supportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Triple P online without professional support |
| Control group | No intervention | Control group without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (4)
Parenting Scale (PS)
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.
Measured: One month
Parenting Task Checklist (PTC)
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).
Measured: One month
Alabama Parenting Questionnaire (APQ)
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.
Measured: One month
The Strengths and Difficulties Questionnaire (SDQ)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start6 Apr 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Municipalidad de Lo Barnechea, Chile
- Responsible party
- Principal investigator, Jorge Gaete, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873310
- Sponsor's protocol ID
- MLB-TripleP-2021
- Acronym
- TriplePChile
- Status last verified
- Oct 2021
- First submitted
- 21 Apr 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Investigators plan to deposit the data collected in this study in the "UK Data Service". Data sharing will never compromise participant privacy, neither schools nor students.
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.
PubMed 22982082Arnold 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.
PubMed 10197403Sanders 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.
PubMed 15658967
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior Problems Prevention Using the Online Triple P Parenting Program: Pilot Study of Acceptability and Feasibility
- ClinicalTrials.gov ID
- NCT04873310
- Acronym / sponsor ID
- TriplePChile / MLB-TripleP-2021
- Conditions
- Parenting
- Keywords
- program, parental competence, behavior problems, emotional problems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,920 participants (estimated)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Collaborators
- Municipalidad de Lo Barnechea, Chile
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Triple P online with professional support | Experimental | Other: Triple P online with professional supportIn 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. |
| Triple P online without professional support | Experimental | Other: Triple P online without professional supportIn 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. |
| Control group | No intervention | –Control group without any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triple P online with professional supportThe 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 | Other | Triple P online with professional support |
| Triple P online without professional supportThe 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 |
Primary outcome
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.
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.
4 secondary outcomes
Parenting Scale (PS)
Time frame: One month
Parenting Task Checklist (PTC)
Time frame: One month
Alabama Parenting Questionnaire (APQ)
Time frame: One month
The Strengths and Difficulties Questionnaire (SDQ)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Results publication: PubMed 22982082Sanders 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.
- Results publicationArnold 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
- Results publication: PubMed 10197403Goodman 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.
- Results publication: PubMed 15658967Sanders 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.
- Individual participant dataSharing planned: Undecided. Investigators plan to deposit the data collected in this study in the "UK Data Service". Data sharing will never compromise participant privacy, neither schools nor students.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple P online with professional support and Triple P online without professional support in people with Parenting, run by Universidad de los Andes, Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Gaete, Phd (+56940245650, jgaete@uandes.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the program by parents/main caregivers using the Acceptability Scale (AS) (time frame: Inmediately Post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04873310, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021; AzTrials last refreshed its copy on 26 Oct 2026.