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

Primary Purpose

Childhood Disruptive Behavior Disorders, Oppositional Defiant Disorder, Conduct Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Triple P--Positive Parenting Program
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Disruptive Behavior Disorders

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

  • Oregon Research Institute
  • Parenting & Family Research Center, University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Online-Delivered Parenting Intervention

Staff-Delivered Parenting Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

childhood disruptive behavior problems
parental report; independent observation; teacher report

Secondary Outcome Measures

parenting behavior
parental report; independent observation
parent and family stress
parenting daily hassles; impact on family quality of life

Full Information

First Posted
April 21, 2014
Last Updated
April 16, 2019
Sponsor
University of South Carolina
Collaborators
Oregon Research Institute, University of Georgia, The University of Queensland
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1. Study Identification

Unique Protocol Identification Number
NCT02121431
Brief Title
Child and Family Outcomes and Consumer Satisfaction for Online vs Staff-Delivered Parenting Intervention
Acronym
TPAS
Official Title
Online vs Staff Delivery: Child & Family Outcomes, Value Analysis, Satisfaction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
Oregon Research Institute, University of Georgia, The University of Queensland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Disruptive Behavior Disorders, Oppositional Defiant Disorder, Conduct Disorder, Attention Deficit Hyperactivity Disorder, Parent-Child Interactions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online-Delivered Parenting Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Staff-Delivered Parenting Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Triple P--Positive Parenting Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
childhood disruptive behavior problems
Description
parental report; independent observation; teacher report
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
parenting behavior
Description
parental report; independent observation
Time Frame
baseline, 4 months (T2), 12 months (T3)
Title
parent and family stress
Description
parenting daily hassles; impact on family quality of life
Time Frame
baseline, 4 months (T2), 12 months (T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: already in a family-based treatment child has pervasive developmental disorder parent under 20 years of age parent has serious mental illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald J Prinz, Ph.D.
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Facility Name
Parenting & Family Research Center, University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35275084
Citation
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.
Results Reference
derived
PubMed Identifier
33829499
Citation
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.
Results Reference
derived

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

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