RecruitingNot ApplicableNCT05647772

Digital Therapeutics for Behavior Problems

Reach and Scalability of Digital Therapeutics for Childhood Behavior Problems

Sponsor

University of Pittsburgh

Enrollment

324 participants

Start Date

Dec 3, 2022

Study Type

INTERVENTIONAL

Conditions

Child Behavior Problem Behavior

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

Min Age: 5 YearsMax Age: 8 Years

Inclusion Criteria5

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 Criteria2

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

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Interventions

BEHAVIORALUseIt! App

The UseIt! app is a parenting app with evidence-based parent management content. The app runs on both Android and iOS devices. It includes a digital library of parent management skills, a trouble-shooting guide, a behavior diary, a point counter, and a skills-alarm.

BEHAVIORALCoach

The coach is be a bachelor's level paraprofessional with a degree in psychology or an allied discipline (e.g., social work) who provides support to parents. The coach will provide motivation and accountability but will not provide therapeutic/clinical support. The primary goal of the coach is to increase participant engagement with the UseIt! mHealth system.

BEHAVIORALSmilingMind App

The control app is a mindfulness app called SmilingMind. It is available for both Android and iOS devices.