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

Sponsor

University of South Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT02121431

Collaborator

Oregon Research Institute (Other), University of Georgia (Other), The University of Queensland (Other)

334

Enrollment

Locations

Arms

Duration (Months)

167

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

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.

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	N/A

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 Design

Study Type:

Interventional

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 :

Apr 1, 2014

Actual Primary Completion Date :

Apr 1, 2019

Actual Study Completion Date :

Apr 1, 2019

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

childhood disruptive behavior problems [up to 12 months]
parental report; independent observation; teacher report

Secondary Outcome Measures

parenting behavior [baseline, 4 months (T2), 12 months (T3)]
parental report; independent observation
parent and family stress [baseline, 4 months (T2), 12 months (T3)]
parenting daily hassles; impact on family quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 7 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Research Institute	Eugene	Oregon	United States	97403
2	Parenting & Family Research Center, University of South Carolina	Columbia	South Carolina	United States	29208