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Digital Therapeutics for Behavior Problems

NCT05647772 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2025-09-23

No results posted yet for this 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).

Conditions

  • Problem Behavior
  • Child Behavior

Interventions

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.

Sponsors & Collaborators

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

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Oliver Lindhiem, PhD · University of Pittsburgh, Department of Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-03
Primary Completion
2026-10-31
Completion
2027-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05647772 on ClinicalTrials.gov