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

Attention Deficit Hyperactivity Disorder Clinical Trial

— TPAS  

Official title:

Online vs Staff Delivery: Child & Family Outcomes, Value Analysis, Satisfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121431
• Other study ID #: Pro00024933
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: April 1, 2019

Study information

• Verified date: April 2019
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Childhood Disruptive Behavior Disorders
• Conduct Disorder
• Disease
• Mental Disorders
• Oppositional Defiant Disorder
• Parent-Child Interactions
• Problem Behavior

Intervention

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.

Locations

Country	Name	City	State
United States	Parenting & Family Research Center, University of South Carolina	Columbia	South Carolina
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
University of South Carolina	Oregon Research Institute, The University of Queensland, University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	childhood disruptive behavior problems	parental report; independent observation; teacher report	up to 12 months
Secondary	parenting behavior	parental report; independent observation	baseline, 4 months (T2), 12 months (T3)
Secondary	parent and family stress	parenting daily hassles; impact on family quality of life	baseline, 4 months (T2), 12 months (T3)