Actively Recruiting

Phase Not Applicable
Age: 5Years - 8Years
All Genders
NCT05647772

Digital Therapeutics for Behavior Problems

Led by University of Pittsburgh · Updated on 2025-09-23

324

Participants Needed

1

Research Sites

225 weeks

Total Duration

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Sponsors

U

University of Pittsburgh

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Digital Therapeutics for Behavior Problems

Who Can Participate

Age: 5Years - 8Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Bellefield Towers

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

A

Abby Angus, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

3

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