NCT02121431

Brief Summary

This trial addresses a serious and all-too-frequent public health problem, namely early-onset disruptive behavior problems in young children. The focus is on testing an online treatment program which empowers parents to help their children to improve their mental health and behavioral functioning. At the conclusion of the study, the investigators will know whether the online-delivered program works as well as an established staff-delivered program, with respect to child disruptive behavior problems, parenting, parent/family stress, consumer satisfaction, and value analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

5 years

First QC Date

April 21, 2014

Last Update Submit

April 16, 2019

Conditions

Childhood Disruptive Behavior DisordersOppositional Defiant DisorderConduct DisorderAttention Deficit Hyperactivity DisorderParent-Child Interactions

Outcome Measures

Primary Outcomes (1)

  • childhood disruptive behavior problems

    parental report; independent observation; teacher report

    up to 12 months

Secondary Outcomes (2)

  • parenting behavior

    baseline, 4 months (T2), 12 months (T3)

  • parent and family stress

    baseline, 4 months (T2), 12 months (T3)

Study Arms (2)

Online-Delivered Parenting Intervention

EXPERIMENTAL

The Online-Delivered Parenting Intervention, which is based on the Triple P--Positive Parenting Program system of interventions, is an interactive website designed to engage and activate the participant through sequenced, personalized, interactive, and video-based content. The intervention emphasizes a self-regulatory process, parent specification of goals, practical and straightforward parenting strategies, modeling, and action activation.

Behavioral: Triple P--Positive Parenting Program

Staff-Delivered Parenting Intervention

ACTIVE COMPARATOR

The Staff-Delivered Parenting Intervention is based on the Triple P--Positive Parenting Program system and involves 10 face-to-face sessions with each family. This intervention is the well-established Level 4 Standard Triple P program.

Behavioral: Triple P--Positive Parenting Program

Interventions

Triple P--Positive Parenting ProgramBEHAVIORAL

The Triple P--Positive Parenting Program (Triple P), which has an extensive evidence base, is grounded in a common set of core principles of positive parenting and draws on a broad menu of parenting strategies. A key provision of Triple P is that parents are the decision-makers about program goals and selection/implementation of specific parenting strategies consistent with their preferences and values.

Online-Delivered Parenting InterventionStaff-Delivered Parenting Intervention

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • clinically elevated level of child disruptive behavior problems
  • parent resides with the child and has primary custody
  • parent has access to internet via computer, e-tablet, or smartphone

You may not qualify if:

  • already in a family-based treatment
  • child has pervasive developmental disorder
  • parent under 20 years of age
  • parent has serious mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Parenting & Family Research Center, University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (2)

  • Ingels JB, Corso PS, Prinz RJ, Metzler CW, Sanders MR. Online-Delivered Over Staff-Delivered Parenting Intervention for Young Children With Disruptive Behavior Problems: Cost-Minimization Analysis. JMIR Pediatr Parent. 2022 Mar 11;5(1):e30795. doi: 10.2196/30795.

    PMID: 35275084DERIVED

  • Prinz RJ, Metzler CW, Sanders MR, Rusby JC, Cai C. Online-delivered parenting intervention for young children with disruptive behavior problems: a noninferiority trial focused on child and parent outcomes. J Child Psychol Psychiatry. 2022 Feb;63(2):199-209. doi: 10.1111/jcpp.13426. Epub 2021 Apr 8.

    PMID: 33829499DERIVED

MeSH Terms

Conditions

Oppositional Defiant DisorderConduct DisorderAttention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Ronald J Prinz, Ph.D.

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Carolina Distinguished Professor

Study Record Dates

First Submitted

April 21, 2014

First Posted

April 23, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

US(2)