RECRUITING

Digital Health Intervention for Children With ADHD

Conditions

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

To conduct an RCT to evaluate the efficacy of the system, we will recruit 60 children (ages 8-12) with ADHD who will be randomized to either immediate (n=30) or delayed (n=30) treatment (i.e., a wait-list control group). Among those randomized to immediate treatment, half will be assigned to DHI (delivered via a smartwatch and smartphone application) and half will be assigned to an active control treatment as usual (TAU) group who will receive the smartwatch with no assigned activities, applications, or interventions on the devices. The intervention period will last 16 weeks; after a participant has been in the delayed treatment group for 16 weeks and has completed the post-waiting period assessment, he or she will be assigned to either the intervention or active control group. Thus, 30 participants will complete the intervention and 30 will complete the active control, with half of the total sample also completing a wait-list period.

Official Title

Digital Health Intervention for Children With ADHD: Improving Mental Health Intervention, Patient Experiences, and Outcomes

Quick Facts

Study Start:2025-02-22
Study Completion:2027-09-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06456372

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:8 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. DSM-5TR diagnosis of ADHD through prior medical or psychological evaluations at the time of admission to the program,
  2. 2. ability to complete questionnaires and use an app in English,
  3. 3. reported IQ of at least 80 in order to ensure that the participant has the cognitive skills needed to use the app, and
  4. 4. parent/guardian available to consent and provide feedback in English.
  1. * Failure to meet any of the inclusion criteria

Contacts and Locations

Study Contact

Jaime Smith
CONTACT
951-827-0741
jaime.smith@medsch.ucr.edu
Kimberley Lakes
CONTACT
951-827-2410
kimberley.lakes@medsch.ucr.edu

Study Locations (Sites)

The Craig School
Irvine, California, 92612
United States
UCR Psychiatry at Grindstaff Community School
Riverside, California, 92503
United States

Collaborators and Investigators

Sponsor: University of California, Riverside

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 Date2025-02-22
Study Completion Date2027-09-29

Study Record Updates

Study Start Date2025-02-22
Study Completion Date2027-09-29

Terms related to this study

Additional Relevant MeSH Terms

  • ADHD