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Active Not Recruiting
NCT05647772
Digital Therapeutics for Behavior Problems
Conditions: Problem Behavior, Child Behavior
Sex: All
Ages: 5 Years – 8 Years
Healthy volunteers: No
Phase: NA
Enrollment: 324
Sponsor: University of Pittsburgh
Location: Bellefield Towers Pittsburgh Pennsylvania
Summary
In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Parents of children (ages 5-8) with disruptive behaviors (N = 324 subjects) will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted app), or Group 3 (control app).
Eligibility Criteria
Inclusion Criteria:
* Males or females between the ages of 5-8 years
* Above the 90th percentile for Oppositional Defiant Disorder (ODD) and/or conduct disorders (CD) on the Vanderbilt Assessment Scale
* Residence with at least one parent/guardian at least 80% of the time
* Parent/legal guardian consent for participation
* Parent/guardian must have a smartphone device with daily internet access
Exclusion Criteria:
* A known preexisting behavioral or mental health diagnosis requiring alternative treatment (bipolar disorder, major depression, pervasive developmental disorder)
* Currently in treatment for childhood disruptive behavior
Source: ClinicalTrials.gov (NCT05647772). StuddyBuddy aggregates publicly available trial information.