Digital Therapeutics for Behavior Problems

Last updated: September 17, 2025
Sponsor: University of Pittsburgh
Overall Status: Active - Recruiting

Phase

N/A

Condition

Oppositional Defiant Disorder (Odd)

Kleptomania

Treatment

SmilingMind App

Coach

UseIt! App

Clinical Study ID

NCT05647772
STUDY22030138
R01HD106930
  • Ages 5-8
  • All Genders

Study 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

Inclusion Criteria:

  • Males or females between the ages of 5-8 years

  • Above the 90th percentile for Oppositional Defiant Disorder (ODD) and/or conductdisorders (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

Exclusion Criteria:

  • A known preexisting behavioral or mental health diagnosis requiring alternativetreatment (bipolar disorder, major depression, pervasive developmental disorder)

  • Currently in treatment for childhood disruptive behavior

Study Design

Total Participants: 324
Treatment Group(s): 3
Primary Treatment: SmilingMind App
Phase:
Study Start date:
December 03, 2022
Estimated Completion Date:
April 30, 2027

Study Description

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. Aim 1 is to evaluate the effectiveness of the UseIt! mHealth system as both a standalone and coach-assisted intervention compared to a control app condition. Aim 2 is to assess target (parent management training/cognitive behavioral therapy skill acquisition and use) engagement and validation. Aim 3 is to evaluate the effectiveness of the components of the UseIt! mHealth system. The investigators plan to recruit an anticipated total of 324 families for the study. Families will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted), or Group 3 (control app condition). Parents will use the app for four months before the administration of the post-treatment assessment. Parents will be trained to use the UseIt! mHealth system over the phone. The coach for the Group 2 condition will be a bachelor's level paraprofessional with a degree in psychology or an allied discipline (e.g., social work) who will provide support to parents. The system is very user friendly and families can be trained in approximately 30 minutes. Assessments will take place at Baseline, Post (4 months from baseline), and 6-month follow-up. All assessments will be conducted online (Qualtrics survey links sent via email by research staff) and take approximately 1 hour to complete.

Connect with a study center

  • Bellefield Towers

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Bellefield Towers

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Active - Recruiting

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