ClinicalTrials.gg
CompletedNCT02121431TPASUpdated Apr 18, 2019

Child and Family Outcomes and Consumer Satisfaction for Online vs Staff-Delivered Parenting Intervention

An interventional study of Triple P--Positive Parenting Program in Childhood Disruptive Behavior Disorders, Oppositional Defiant Disorder and Conduct Disorder, sponsored by University of South Carolina. Completed at 2 sites in United States. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2019-04-18.

Sponsored by University of South Carolina · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
334
Allocation
Randomized
Ages
3 Years to 7 Years
Sex
All
01

Study 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.

Read the detailed description

High-prevalence mental health problems require innovative strategies to broaden reach of evidence-based services. Disruptive behavior problems (DBPs), or conduct problems, in young children represent a major public health challenge that is not only highly prevalent but also, left untreated, heighten risk for adverse mental health and developmental outcomes in adolescence and adulthood. Internet and online technology has considerable potential to help achieve such a goal. Building on parenting interventions that have demonstrated impact on childhood DBPs, this clinical trial compares an online-delivered intervention to a well-validated staff-delivered intervention, holding program content constant. Both interventions are based on the Triple P-Positive Parenting Program. The sample includes families with a 3-7 year old child who has a pronounced level of DBPs. The study makes use of a non-inferiority trial design to determine whether the online-delivered intervention yields as good outcomes as the well-established staff-delivered intervention with respect to childhood DBPs, parenting, and parent/family stress. The study also includes a value analysis comparing the two interventions, accounting for provider and participant expenses as well as pre-implementation and implementation phases. This study is intended to shed light on the impact and potential benefits of a viable online parenting intervention for childhood disruptive behavior problems, but the results from this study are also intended to help the mental health field to better understand more broadly the potential advantages and disadvantages of online interventions over traditionally delivered interventions, particularly in light of expense minimization/effectiveness analysis.

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Conditions studied

  • Childhood Disruptive Behavior Disorders
  • Oppositional Defiant Disorder
  • Conduct Disorder
  • Attention Deficit Hyperactivity Disorder
  • Parent-Child Interactions
03

In context

Oppositional Defiant Disorder

86 studies on the registry are indexed under Oppositional Defiant Disorder; 16 are open to participants now.

This study's enrollment of 334 is above the median of 102 across 76 interventional studies indexed under Oppositional Defiant Disorder.

Browse Oppositional Defiant Disorder studies →

Lead sponsor

University of South Carolina is the lead sponsor of 197 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • already in a family-based treatment
  • child has pervasive developmental disorder
  • parent under 20 years of age
  • parent has serious mental illness
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
334 participants (actual)

Study arms

  • Experimental
    Online-Delivered Parenting Intervention

    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

  • Active comparator
    Staff-Delivered Parenting Intervention

    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

  • BehavioralTriple P--Positive Parenting Program

    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.

06

What researchers measure

Primary outcomes

  1. childhood disruptive behavior problems

    parental report; independent observation; teacher report

    Time frame: up to 12 months

Secondary outcomes

  1. parenting behavior

    parental report; independent observation

    Time frame: baseline, 4 months (T2), 12 months (T3)

  2. parent and family stress

    parenting daily hassles; impact on family quality of life

    Time frame: baseline, 4 months (T2), 12 months (T3)

07

Study locations

2 sites
  • Oregon Research Institute
    Eugene, Oregon 97403, United States
  • Parenting & Family Research Center, University of South Carolina
    Columbia, South Carolina 29208, United States
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References and documents

Publications

  • 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. PubMed 35275084 ↗
  • 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. PubMed 33829499 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2014, a primary completion of Apr 2019 and a completion of Apr 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2014
First posted
Apr 23, 2014
Start
Apr 2014
Primary completionActual
Apr 1, 2019
CompletionActual
Apr 1, 2019
Last update
Apr 18, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02121431
Collaborators
Oregon Research Institute, University of Georgia, The University of Queensland
Responsible party
Ron Prinz, PhD (Carolina Distinguished Professor, University of South Carolina) — Principal investigator
First posted
Apr 23, 2014
Start date
Apr 2014
Primary completion
Apr 1, 2019
Completion
Apr 1, 2019
Last update
Apr 18, 2019

Study contacts

Ronald J Prinz, Ph.D.
principal investigator · University of South Carolina

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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