RECRUITING

Digital Therapeutics for Behavior Problems

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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).

Official Title

Reach and Scalability of Digital Therapeutics for Childhood Behavior Problems

Quick Facts

Study Start:2022-12-03
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05647772

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 8 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Males or females between the ages of 5-8 years
  2. * Above the 90th percentile for Oppositional Defiant Disorder (ODD) and/or conduct disorders (CD) on the Vanderbilt Assessment Scale
  3. * Residence with at least one parent/guardian at least 80% of the time
  4. * Parent/legal guardian consent for participation
  5. * Parent/guardian must have a smartphone device with daily internet access
  1. * A known preexisting behavioral or mental health diagnosis requiring alternative treatment (bipolar disorder, major depression, pervasive developmental disorder)
  2. * Currently in treatment for childhood disruptive behavior

Contacts and Locations

Study Contact

Abby Angus, BS
CONTACT
412-586-9181
angusar@upmc.edu

Principal Investigator

Oliver Lindhiem, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh, Department of Psychiatry

Study Locations (Sites)

Bellefield Towers
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-03
Study Completion Date2027-04

Study Record Updates

Study Start Date2022-12-03
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • Oppositional Defiant Disorder (ODD)
  • Conduct Disorder (CD)
  • Childhood Behavioral Disorders
  • Mobile Health

Additional Relevant MeSH Terms

  • Problem Behavior
  • Child Behavior