NCT02064452

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

2.8 years

First QC Date

February 12, 2014

Last Update Submit

April 17, 2019

Conditions

Keywords

behavior problemschildrenpreventionparentingonlinepediatric

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline at T2 and T3 on Parenting and Family Adjustment Scale (Sanders & Morawska, 2010)

    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 Outcomes (7)

  • Child Adjustment and Parent Efficacy Scale (Morawska & Sanders, 2010)

    T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).

  • Knowledge of Effective Parenting Scale (Winter, Morawska, & Sanders, 2011)

    T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).

  • Child and Adolescent Disruptive Behavior Inventory (Burns, Taylor, & Rusby, 2001)

    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)

    T1 (Baseline), T2 (16 weeks after T1), T3 (1 year after T2).

  • Preschool Age Psychiatric Assessment (Egger & Angold, 2004)

    T1 (Baseline), T3 (1 year after T2).

  • +2 more secondary outcomes

Study Arms (2)

Triple P Online System

EXPERIMENTAL

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

Enhanced Usual Community Care-Waitlist

PLACEBO COMPARATOR

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

Interventions

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.

Triple P Online System

Enhanced Usual Community Care-Waitlist

Enhanced Usual Community Care-Waitlist

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Seattle Children's Research Institute

Seattle, Washington, 98121, United States

Location

MeSH Terms

Conditions

Oppositional Defiant DisorderConduct DisorderAttention Deficit Disorder with HyperactivityMental Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Study Officials

  • Carol W Metzler, PhD

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 17, 2014

Study Start

May 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2019

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations