- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02064452
Evaluating an Online Parenting Support System Disseminated by Pediatric Practices
April 17, 2019 updated by: Oregon Research Institute
This study will experimentally evaluate an internet-based version of the Triple P Positive Parenting Program, the Triple P Online System (TPOS), which presents the Triple P content in an interactive, video-enriched, and personalized format with 3-levels of flexible dosage, and will compare it against usual community services.
Thirty pediatric clinics involving 100 practitioners in 9 counties across western Washington will be recruited and randomized to receive (a) access for their patients to the Triple P Online System and training in how to effectively promote TPOS and advise parents on their children's behavior problems or (b) Usual Care Community-Waitlist Control, in which parents will be assisted with an appropriate referral for services in the community.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Disruptive behavior problems are among the most prevalent mental health conditions for young children, and they carry significant risks for later socioemotional, conduct, and academic problems, such as substance abuse, delinquency, and school failure.
How parents handle these challenging behaviors strongly influences their children's long-term trajectory.
Evidence-based parenting programs have shown much value in reducing early-onset disruptive behavior problems, thereby reducing risks for later substance abuse and other behavioral health problems.
The reach of parenting programs is limited, however, by significant challenges in recruiting, engaging, and retaining parents, such that most parents who could benefit from parenting assistance never receive it.
A public health approach for improving parenting practices that makes evidence-based parenting programs widely available and accessible in a range of formats could reduce the prevalence of disruptive behavior problems, and thus the population-level risk for substance abuse and other adverse outcomes.
Internet-based intervention offers significant potential as part of a population-wide strategy for bringing evidence-based parenting practices to a broad range of parents experiencing challenges in raising their children.
Furthermore, pediatricians could be a natural touchpoint for reaching families with evidence-based parenting supports.
The field knows little, however, about the potential of the internet to strengthen parenting practices, or about how pediatric practitioners might be engaged in improving the reach of an online parenting program.
This study will experimentally evaluate an internet-based version of the Triple P Positive Parenting Program, the Triple P Online System (TPOS), which presents the Triple P content in an interactive, video-enriched, and personalized format with 3-levels of flexible dosage, and will compare it against usual community services.
Thirty pediatric clinics involving 100 practitioners in 9 counties across western Washington will be recruited and randomized to receive (a) access for their patients to the Triple P Online System and training in how to effectively promote TPOS and advise parents on their children's behavior problems or (b) Usual Care Community-Waitlist Control, in which parents will be assisted with an appropriate referral for services in the community.
Practitioners will recruit into their respective conditions 400 families of 3-8 year-old children with elevated behavior problems.
Measures of parents' parenting practices, family functioning, children's disruptive behavior problems, and practitioners' protocols for advising on behavior problems will be obtained at baseline, post-intervention, and 1-year follow-up.
The efficacy of the Triple P Online System in improving these outcomes will be examined, as well as dosage-response relationships.
This study will further our understanding of the potential value of promoting internet-based parenting programs through pediatric practitioners.
Maximizing the reach of evidence-based parenting programs has the potential to reduce the prevalence of children's behavior problems, and thus reduce risks for later problems such as substance abuse.
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Eugene, Oregon, United States, 97403
- Oregon Research Institute
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Washington
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Seattle, Washington, United States, 98121
- Seattle Children's Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pediatric practitioners at participating clinics in western Washington.
- Families of children 3-8 years old referred by participating pediatric practitioners. Eligible families will: (a) have a child 3-8 years old, (b) have at least half-time custody of the child, (c) care for the child at least 16 waking hours per week, (d) express concern to their practitioner about difficulties with the child's behavior, (e) score .80 standard deviation or more above the normed mean on the Eyberg Child Behavior Inventory, (f) speak English, and (g) have regular access to high-speed internet.
Exclusion Criteria:
- None.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Triple P Online System
The Triple P Online System (TPOS) is an interactive, video-driven online parenting support website, delivered with 3 different levels of intensity, depending on severity of children's behavior problems.
In this arm, pediatric clinics are randomized to receive training in child disruptive behavior disorders, Triple P principles and target parenting strategies, the Triple P Online System, effectively referring eligible families to TPOS, and supporting their use of the program.
Referred parents in this condition receive access to TPOS immediately.
|
The Triple P Online System (TPOS) is an online parenting support program designed to assist parents in developing effective parenting practices for handling their children's problem behaviors.
Content focuses on positive attention and praise, teaching strategies, effective discipline, antecedent strategies to avoid problems in high-risk situations, and applying these principles to specific situations.
TPOS integrates 3 different levels of program intensity to meet different levels of family need, based on severity of children's behavior problems.
|
Placebo Comparator: Enhanced Usual Community Care-Waitlist
In this arm, pediatric clinics are randomized to receive access for their parents and practitioners to a referral website designed to assist parents of children with disruptive behavior disorders in accessing appropriate community resources; on the website, community resources for treatment of child disruptive behavior disorders (mental health services, parenting services) are described and can be searched by location, cost, and acceptance of Medicare.
Parents in this condition receive access to the Triple P Online System (TPOS) after completion of their 1-year follow-up assessment.
Pediatricians receive free training in TPOS at the end of their waiting period.
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Enhanced Usual Community Care-Waitlist
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline at T2 and T3 on Parenting and Family Adjustment Scale (Sanders & Morawska, 2010)
Time Frame: T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
|
40-item parent-report questionnaire; assesses discipline practices, positive parenting, parent mood, family relationships, and co-parenting support at T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
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T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Adjustment and Parent Efficacy Scale (Morawska & Sanders, 2010)
Time Frame: T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
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Parent-report questionnaire; 30 items measure children's emotional and behavioral problems and positive behaviors; 20 items measures parents' self-efficacy for handling the problem behaviors
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T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
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Knowledge of Effective Parenting Scale (Winter, Morawska, & Sanders, 2011)
Time Frame: T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
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Multiple-choice parenting knowledge quiz
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T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
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Child and Adolescent Disruptive Behavior Inventory (Burns, Taylor, & Rusby, 2001)
Time Frame: T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
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Parent-report questionnaire measuring children's oppositional behavior to adults, oppositional behavior to other children, hyperactivity, and conduct problems
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T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
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Parent Daily Report (adapted from Chamberlain & Reid, 1987), coded with the Parent Discipline Interview Coding System (Rusby, Metzler, Sanders & Ware, 2010)
Time Frame: T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
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Series of 3 phone interviews with mother at each timepoint; mother reports on frequency of specific problematic and positive child behaviors over the past 24 hours.
Mother reports how she handled the two most problematic behaviors; answers are coded by independent coders.
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T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
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Preschool Age Psychiatric Assessment (Egger & Angold, 2004)
Time Frame: T1 (Baseline), T3 (1 year after T2).
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Diagnostic interview, administered over the phone to mothers, used for study children ages 3-5; modules assessing Oppositional Defiant Disorder, Conduct Disorder, and Attention Deficit Hyperactivity Disorder are utilized.
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T1 (Baseline), T3 (1 year after T2).
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National Institute of Mental Health Diagnostic Interview Schedule for Children Version IV (Shaffer, Fisher, Lucas, Dulcan & Schwab-Stone, 2000)
Time Frame: T1 (Baseline), T3 (1 year after T2).
|
Diagnostic interview, administered over the phone to mothers, used for study children ages 6-8; modules assessing Oppositional Defiant Disorder, Conduct Disorder, and Attention Deficit Hyperactivity Disorder are utilized.
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T1 (Baseline), T3 (1 year after T2).
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Pediatricians' self-efficacy for advising parents of children with conduct problems, typical referral patterns for these problems, attitudes toward evidence-based self-administered parenting interventions
Time Frame: T1 (Baseline), T2 (10 months after T1), T3 (1 year after T2).
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pediatrician-reported questionnaire
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T1 (Baseline), T2 (10 months after T1), T3 (1 year after T2).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carol W Metzler, PhD, Oregon Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2014
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
February 12, 2014
First Submitted That Met QC Criteria
February 13, 2014
First Posted (Estimate)
February 17, 2014
Study Record Updates
Last Update Posted (Actual)
April 18, 2019
Last Update Submitted That Met QC Criteria
April 17, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA021307-06A1
- 2R01DA021307-06A1 (U.S. NIH Grant/Contract)
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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