Digital Therapeutics for Behavior Problems

University of Pittsburgh

Status: Enrolling

Conditions: Child Behavior; Problem Behavior

Treatments: Behavioral: UseIt! App; Behavioral: Coach; Behavioral: SmilingMind App

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05647772

STUDY22030138

R01HD106930 (U.S. NIH Grant/Contract)

Details and patient eligibility

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).

Full 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.

Enrollment: 324 estimated patients

Sex: All

Ages: 5 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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324 participants in 3 patient groups

Group 1: Standalone App

Experimental group

Description:

Standalone parenting app called UseIt!

Treatment:

Behavioral: UseIt! App

Group 2: App plus Coach

Experimental group

Description:

Standalone parenting app called UseIt! plus a coach.

Treatment:

Behavioral: Coach

Behavioral: UseIt! App

Group 3: Control App

Active Comparator group

Description:

Control condition: mindfulness app called SmilingMind.

Treatment:

Behavioral: SmilingMind App