NCT05647772

Digital Therapeutics for Behavior Problems

Reach and Scalability of Digital Therapeutics for Childhood Behavior Problems

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Problem Behavior
• Child Behavior

Interventions

Type	Name	Description
BEHAVIORAL	UseIt! 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.
BEHAVIORAL	Coach	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.
BEHAVIORAL	SmilingMind App	The control app is a mindfulness app called SmilingMind. It is available for both Android and iOS devices.

Timeline

• Start date: 2022-12-03
• Primary completion: 2026-10-01
• Completion: 2027-04-01
• First posted: 2022-12-12
• Last updated: 2025-09-23

Locations

1 site across 1 country: United States