Evaluating an Online Parenting Support System Disseminated by Pediatric Practices

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Oregon Research Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT02064452
First received: February 12, 2014
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Child Disruptive Behavior Disorders
Oppositional Defiant Disorder
Conduct Disorder
Attention Deficit Hyperactivity Disorder
Other: Triple P Online System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating an Online Parenting Support System Disseminated by Pediatric Practices

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Child Adjustment and Parent Efficacy Scale (Morawska & Sanders, 2010) [ Time Frame: T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2). ] [ Designated as safety issue: No ]
    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

  • Knowledge of Effective Parenting Scale (Winter, Morawska, & Sanders, 2011) [ Time Frame: T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2). ] [ Designated as safety issue: No ]
    Multiple-choice parenting knowledge quiz

  • Child and Adolescent Disruptive Behavior Inventory (Burns, Taylor, & Rusby, 2001) [ Time Frame: T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2). ] [ Designated as safety issue: No ]
    Parent-report questionnaire measuring children's oppositional behavior to adults, oppositional behavior to other children, hyperactivity, and conduct problems

  • 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). ] [ Designated as safety issue: No ]
    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.

  • Preschool Age Psychiatric Assessment (Egger & Angold, 2004) [ Time Frame: T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2). ] [ Designated as safety issue: No ]
    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.

  • National Institute of Mental Health Diagnostic Interview Schedule for Children Version IV (Shaffer, Fisher, Lucas, Dulcan & Schwab-Stone, 2000) [ Time Frame: T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2). ] [ Designated as safety issue: No ]
    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.

  • 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). ] [ Designated as safety issue: No ]
    pediatrician-reported questionnaire


Estimated Enrollment: 700
Study Start Date: May 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 500 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.

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02064452

Contacts
Contact: Carol W Metzler, PhD 541-484-2123 ext 2243 carolm@ori.org
Contact: Julie C Rusby, PhD 541-484-2123 ext 2253 juliecr@ori.org

Locations
United States, Oregon
Oregon Research Institute Not yet recruiting
Eugene, Oregon, United States, 97403
Contact: Jason Blair, BS    541-484-2123 ext 2288    jasonb@ori.org   
Contact: Susan Long, MS    541-484-2123 ext 2117    susanl@ori.org   
Principal Investigator: Carol W Metzler, PhD         
United States, Washington
Seattle Children's Research Institute Not yet recruiting
Seattle, Washington, United States, 98121
Contact: Erin McCormick    206-884-1843    erin.mccormick@seattlechildrens.org   
Principal Investigator: Frederick Rivara, MD         
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Carol W Metzler, PhD Oregon Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT02064452     History of Changes
Other Study ID Numbers: DA021307-06A1, 2R01DA021307-06A1
Study First Received: February 12, 2014
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Research Institute:
behavior problems
children
prevention
parenting
online
pediatric

Additional relevant MeSH terms:
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Attention Deficit Disorder with Hyperactivity
Conduct Disorder
Hyperkinesis
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014