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Completed

NCT Number: NCT02121431

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

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.

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Key information

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Research Institute, Eugene, Oregon, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triple P--Positive Parenting Program

Behavioral

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 outcomes

  1. childhood disruptive behavior problems

    Time frame: up to 12 months

    parental report; independent observation; teacher report

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • Oregon Research Institute
  • The University of Queensland
  • University of Georgia

Registry information

Official study title

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

Acronym: TPAS

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2014
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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