Mobile health intervention for children with behavior problems
Reach and Scalability of Digital Therapeutics for Childhood Behavior Problems
NA · University of Pittsburgh · NCT05647772
This study is testing a mobile app to see if it can help children aged 5-8 with behavior problems, with some families getting extra support from a coach.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 5 Years to 8 Years |
| Sex | All |
| Sponsor | University of Pittsburgh (other) |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05647772 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of a mobile health (mHealth) system designed to address disruptive behaviors in children aged 5-8. Families will be randomly assigned to one of three groups: a standalone app, a coach-assisted app, or a control app. The study will assess the engagement and effectiveness of the mHealth system over a four-month period, with follow-up assessments conducted online. The intervention includes training for parents to use the app and support from a paraprofessional coach for those in the coach-assisted group.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-8 who exhibit significant oppositional defiant or conduct disorder behaviors.
Not a fit: Patients with preexisting behavioral or mental health diagnoses requiring alternative treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide an accessible and effective tool for parents to manage their children's disruptive behaviors.
How similar studies have performed: Other studies have shown promise in using mobile health interventions for behavioral issues, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pittsburgh, Pennsylvania
- Bellefield Towers — Pittsburgh, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Oliver Lindhiem, PhD — University of Pittsburgh, Department of Psychiatry
- Study coordinator: Abby Angus, BS
- Email: angusar@upmc.edu
- Phone: 412-586-9181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Problem Behavior, Child Behavior, Oppositional Defiant Disorder, Conduct Disorder, Childhood Behavioral Disorders, Mobile Health