Actively Recruiting

Phase Not Applicable
Age: 5Years - 8Years
All Genders
ID05647772

Reach and Scalability of Digital Therapeutics for Childhood Behavior Problems

Led by University of Pittsburgh · Updated on 2025-09-23

324

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

University of Pittsburgh

Lead Sponsor

E

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a mobile health (mHealth) system called UseIt! to help parents manage disruptive behavior in children aged 5 to 8 years. This study compares the effectiveness of the UseIt! app used alone, the app combined with coach support, and a control mindfulness app. The goal is to understand which approach best supports parents and achieves wide reach and scalability for managing behavior problems. Parents will be randomly assigned to one of three groups: using the standalone UseIt! app, using the UseIt! app with added coach assistance, or using the mindfulness control app called SmilingMind. Parents will use their assigned app for four months, receiving phone training on how to use the UseIt! system in about 30 minutes. The coach, for those in the coach-assisted group, is a paraprofessional who supports motivation and engagement but does not provide clinical therapy. Participants will complete assessments online at baseline, after four months of app use, and at a six-month follow-up. These assessments include surveys that take about an hour to complete and measure parenting knowledge and skill use, as well as child behavior symptoms. The primary outcome is measured by the Knowledge of Effective Parenting Test (KEPT) at both post-treatment and follow-up. Secondary outcomes include diaries of parenting skill use and behavior symptom scales. The study plans to enroll 324 families and will continue until April 2027.

CONDITIONS

Brief Title

Digital Therapeutics for Behavior Problems

Who Can Participate

Age: 5Years - 8Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (online)

Outpatient Treatment

Duration - 4 months

Participants use a parenting app alone or with coach support, or a control mindfulness app, to address childhood behavior problems.

Participants complete online assessments at baseline and post-treatment

Follow-up

Duration - 2 months after post-treatment

Participants complete a 6-month follow-up online assessment to evaluate lasting effects of the intervention.

1 follow-up online assessment

Trial Site Locations

Total: 1 location

1

Bellefield Towers

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

A

Abby Angus, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

3

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Published Research Related To This Trial

Novel Smartphone App and Supportive Accountability for the Treatment of Childhood Disruptive Behavior Problems: Protocol for a Randomized Controlled Trial.

Oliver Lindhiem, Claire S Tomlinson, David J Kolko...

https://pubmed.ncbi.nlm.nih.gov/40068698