ParentingTriplePChileNCT01868919
Triple P to Improve Behaviour in Children
A study testing Positive Parenting Program in people with Parenting and Child Behaviour, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting, Child Behaviour, Mental Health Wellness 1
- What is being tested?
- Positive Parenting Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChile
- Study dates
- Nov 2011to May 2013
- 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
- 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
Who cannot join
- Children: Pervasive Developmental Disorder, severe intellectual disability or severe psychopathology
- Caregivers: illiteracy, decompensated severe psychopathology or current psychotherapy
Trial locations and contacts
1 site in 1 country.
Chile1 site
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan
About this study
Official title: 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.
Read the 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.
- Conditions
- Parenting, Child Behaviour, Mental Health Wellness 1, Family Research
- Being tested
- Positive Parenting Program
- Keywords
- "Pilot Projects"[Mesh], "Parenting"[Mesh], "Child Behaviour"[Mesh], "Mental Health"[Mesh], "Family Practice"[Mesh]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Parenting ProgramBehavioural
Also called Triple P
Level 3 or 4 of Triple P
| Study group | Role | What they receive |
|---|---|---|
| Positive Parenting Program | Experimental | Level 3 or 4 of Triple P Receives: Behavioral: Positive Parenting Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess implementability of the program in primary care in terms of feasibility, acceptability and level of participation
Instrument: focus groups
Measured: After one year of implementation
Secondary outcomes (2)
Percentage of change in intensity of behaviour in children
Instrument: Eyberg Child Behaviour Inventory
Measured: After one year of implementation
Fidelity of program implementation
Supervision meetings and video recordings
Measured: After one year of implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gladys Moreno, Dra., Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868919
- Sponsor's protocol ID
- TRIPLEP.PUC.CHILE
- Acronym
- TriplePChile
- Status last verified
- May 2013
- First submitted
- 19 Jan 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Research of a Parenting Intervention to Improve Behaviour in Children in Primary Care
- ClinicalTrials.gov ID
- NCT01868919
- Acronym / sponsor ID
- TriplePChile / TRIPLEP.PUC.CHILE
- Conditions
- Parenting, Child Behaviour, Mental Health Wellness 1, Family Research
- Keywords
- "Pilot Projects"[Mesh], "Parenting"[Mesh], "Child Behaviour"[Mesh], "Mental Health"[Mesh], "Family Practice"[Mesh]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Jun 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive Parenting Program | Experimental | Behavioral: Positive Parenting ProgramLevel 3 or 4 of Triple P |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Children: Pervasive Developmental Disorder, severe intellectual disability or severe psychopathology
- Caregivers: illiteracy, decompensated severe psychopathology or current psychotherapy
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 |
|---|---|---|
| Positive Parenting ProgramAlso: Triple PLevel 3 or 4 of Triple P | Behavioural | Positive Parenting Program |
Primary outcome
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
2 secondary outcomes
Percentage of change in intensity of behaviour in children
Time frame: After one year of implementation
Fidelity of program implementation
Time frame: After one year of implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
- Triple P Chilean websiteLink provided by the sponsor.
- Triple P Official WebsiteLink provided by the sponsor.
- Triple P Provider NetworkLink provided by the sponsor.
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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.
Gladys Moreno, Dra. principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Parenting Program in people with Parenting and Child Behaviour, run by Pontificia Universidad Catolica de 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 2 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: finished, as of the sponsor's last update on 5 Jun 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess implementability of the program in primary care in terms of feasibility, acceptability and level of participation (time frame: After one year of implementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2013.