- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01946958
Triple P With Pediatric Residents
Randomized Control Study of the Impact of Primary Care Triple P on Pediatric Residents and Their Patients
The objective of this study is to conduct a randomized control trial to evaluate the impact of Triple P on the clinic practice of pediatric residents and on select parent and child outcomes. This study will accomplish that overarching goal through addressing two specific aims.
Aim 1. Triple P's Effect on Pediatric Resident's Practice: test the effect of Triple P training on practice of pediatric residents in addressing and managing psychosocial problems.
Hypothesis 1: At the completion of the trial, residents assigned to the intervention group, compared to residents exposed to the control condition, will have:
- increased skill levels,
- increased confidence, and
- increased satisfaction in dealing with and managing psychosocial issues
Aim 2. Triple P's Effect on Parent and Child Outcomes: test the effect of Triple P interventions on parent's feelings of self efficacy, parent's discipline strategies and on children's externalizing behavior.
Hypothesis 2: At the completion of the intervention, parents and children receiving the intervention, compared to those receiving the control condition, will have:
- greater reduction in targeted child behavior problems,
- greater reduction in dysfunctional parenting practices,
- increased use of appropriate discipline and positive parenting strategies, and
- greater confidence in parenting ability.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for Pediatric Resident:
- Assigned to a participating continuity clinic
Exclusion Criteria for Pediatric Resident:
- Not assigned to a participating continuity clinic
Inclusion Criteria for Parent:
- Parent of an eligible child.
- Speaks English
Exclusion Criteria for Parent:
- A parent of an ineligible child
- Non-English speaking
Inclusion Criteria for Child:
- Treated by a participating resident
- Between 18 months and 12 years old
- Does not have any mental health diagnosis
- Is not receiving medication or therapy from a professional
Exclusion Criteria for Child:
- Not treated by a participating resident
- Age falls outside of eligible range
- Has a mental health diagnosis
- Currently receiving medication or therapy from a professional
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trained in Primary Care (PC) Triple P
This group received standardized training in Primary Care (PC) Triple P.
|
PC Triple P is a brief parenting intervention combining specific advice from provider with parent rehearsal and self-evaluation.
|
Experimental: Care as Usal
This group provided care as usual.
This group was not trained in PC Triple P interventions.
|
Pediatric residents not exposed to PC Triple P provide their standard care to parents struggling with parenting issues or child behavior concerns.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pediatric resident skills and confidence in conducting parent consultations about child behavior
Time Frame: One year
|
Pediatric residents will complete a parent consultation skills and confidence assessment at baseline, pre-training, post-training and follow-up.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in family outcomes - parent sense of self efficacy, use of positive discipline and child behavior
Time Frame: One year
|
Parents participating in the study will complete an assessment about their discipline strategies, their sense of confidence as a parent and their child's behavior at baseline and follow-up.
|
One year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Frederick P Rivara, MD, MPH, Seattle Children's Research Institute, Seattle Children's Hospital, University of Washington
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SCH-13683
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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