NCT05647772 Digital Therapeutics for Behavior Problems
| NCT ID | NCT05647772 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Problem Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 324 participants |
| Start Date | 2022-12-03 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 324 participants in total. It began in 2022-12-03 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Oliver Lindhiem, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh, Department of Psychiatry
Frequently Asked Questions
Who can join the NCT05647772 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 8 Years, studying Problem Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05647772 currently recruiting?
Yes, NCT05647772 is actively recruiting participants. Contact the research team at angusar@upmc.edu for enrollment information.
Where is the NCT05647772 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT05647772 clinical trial?
NCT05647772 is sponsored by University of Pittsburgh. The principal investigator is Oliver Lindhiem, PhD at University of Pittsburgh, Department of Psychiatry. The trial plans to enroll 324 participants.