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Digital Therapeutics

Digital Therapy Apps for Childhood Behavior Problems

N/A
Recruiting
Led By Oliver Lindhiem, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-month follow-up (10 months after baseline).
Awards & highlights

Study Summary

This trial will test an app to help parents of children ages 5-8 with disruptive behaviors. Subjects will be randomly assigned to a standalone, coach-assisted, or control app group.

Who is the study for?
This trial is for children aged 5-8 who often show disruptive behaviors and live with a parent most of the time. The child must score high on a behavior scale, and their parent needs to have a smartphone with daily internet. Kids already in treatment or with certain mental health conditions can't join.Check my eligibility
What is being tested?
The study tests an mHealth system's effectiveness for managing childhood behavior problems using two apps: UseIt! App alone, UseIt! App with coach assistance, versus SmilingMind (control). Parents are randomly placed into one of these three groups.See study design
What are the potential side effects?
Since this trial involves digital apps and coaching rather than medication, traditional physical side effects aren't expected. However, there may be indirect effects like increased screen time or potential frustration if the app doesn't improve behaviors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-month follow-up (10 months after baseline).
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month follow-up (10 months after baseline). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Knowledge of Effective Parenting Test (KEPT)
Secondary outcome measures
Conduct Disorder Subscale of the Vanderbilt Assessment
Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment
Parenting Skill Use Diary (PSUD)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Group 2: App plus CoachExperimental Treatment2 Interventions
Standalone parenting app called UseIt! plus a coach.
Group II: Group 1: Standalone AppExperimental Treatment1 Intervention
Standalone parenting app called UseIt!
Group III: Group 3: Control AppActive Control1 Intervention
Control condition: mindfulness app called SmilingMind.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,720 Previous Clinical Trials
16,342,487 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,406 Total Patients Enrolled
Oliver Lindhiem, PhDPrincipal InvestigatorUniversity of Pittsburgh, Department of Psychiatry
2 Previous Clinical Trials
153 Total Patients Enrolled

Media Library

SmilingMind App (Digital Therapeutics) Clinical Trial Eligibility Overview. Trial Name: NCT05647772 — N/A
Disruptive Behaviors Research Study Groups: Group 1: Standalone App, Group 2: App plus Coach, Group 3: Control App
Disruptive Behaviors Clinical Trial 2023: SmilingMind App Highlights & Side Effects. Trial Name: NCT05647772 — N/A
SmilingMind App (Digital Therapeutics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05647772 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass individuals aged 50 and over?

"The age range for this trial is restricted to patients aged 5-8, as specified in the inclusion criteria."

Answered by AI

To what degree is this research study being populated with participants?

"Correct. According to the clinicaltrials.gov archive, this trial was launched on December 3rd 2022 and is still enrolling participants at present day. 324 individuals must be recruited from one medical facility for full participation in this study."

Answered by AI

Are there any vacancies open for participation in this clinical research?

"Affirmative. According to the information compiled on clinicaltrials.gov, this research is still recruiting participants and was first listed on December 3rd 2022 with a subsequent update taking place on the 8th of that month. A total of 324 patients must be found at one medical centre for inclusion in the trial."

Answered by AI

Do I meet the criteria to be accepted into this medical experiment?

"The trial is seeking to enrol 324 minors, aged 5 through 8 years old, who present with aberrant behavior. Essential requirements for admission include: biological sex (male or female), a score greater than the 90th percentile of ODD and/or CD on Vanderbilt Assessment Scale; residence with at least one adult guardian 80% of the time, consent from said parent/guardian, access to a smartphone device that can connect to the internet daily."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Digital Therapeutics for Behavior Problems
Oliver Lindhiem 2022. "Digital Therapeutics for Behavior Problems". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05647772.
~209 spots leftby Oct 2026
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