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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Oregon Research Institute
    • Washington
      • Seattle, Washington, United States, 98121
        • Seattle Children's Research Institute

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Triple P Online System
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.
Behavioral: Placebo Comparator
Enhanced Usual Community Care-Waitlist

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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).
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
T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
Knowledge of Effective Parenting Scale (Winter, Morawska, & Sanders, 2011)
Time Frame: T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
Multiple-choice parenting knowledge quiz
T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
Child and Adolescent Disruptive Behavior Inventory (Burns, Taylor, & Rusby, 2001)
Time Frame: T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
Parent-report questionnaire measuring children's oppositional behavior to adults, oppositional behavior to other children, hyperactivity, and conduct problems
T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
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).
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.
T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).
Preschool Age Psychiatric Assessment (Egger & Angold, 2004)
Time Frame: T1 (Baseline), T3 (1 year after T2).
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.
T1 (Baseline), T3 (1 year after T2).
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.
T1 (Baseline), T3 (1 year after T2).
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).
pediatrician-reported questionnaire
T1 (Baseline), T2 (10 months after T1), T3 (1 year after T2).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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