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

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ClinicalTrials.gov Identifier: NCT02121431
Recruitment Status : Active, not recruiting
First Posted : April 23, 2014
Last Update Posted : June 21, 2018
Sponsor:
Collaborators:
Oregon Research Institute
University of Georgia
The University of Queensland
Information provided by (Responsible Party):
University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Childhood Disruptive Behavior Disorders Oppositional Defiant Disorder Conduct Disorder Attention Deficit Hyperactivity Disorder Parent-Child Interactions Behavioral: Triple P--Positive Parenting Program Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Online vs Staff Delivery: Child & Family Outcomes, Value Analysis, Satisfaction
Study Start Date : April 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
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
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.

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
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 Measures :
  1. childhood disruptive behavior problems [ Time Frame: up to 12 months ]
    parental report; independent observation; teacher report


Secondary Outcome Measures :
  1. parenting behavior [ Time Frame: baseline, 4 months (T2), 12 months (T3) ]
    parental report; independent observation

  2. parent and family stress [ Time Frame: baseline, 4 months (T2), 12 months (T3) ]
    parenting daily hassles; impact on family quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121431


Locations
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
United States, South Carolina
Parenting & Family Research Center, University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Oregon Research Institute
University of Georgia
The University of Queensland
Investigators
Principal Investigator: Ronald J Prinz, Ph.D. University of South Carolina

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT02121431     History of Changes
Other Study ID Numbers: R01MH097699 ( U.S. NIH Grant/Contract )
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Problem Behavior
Conduct Disorder
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes
Neurodevelopmental Disorders
Behavioral Symptoms