Clinical Trial

Digital Health Intervention for Children With ADHD

Recruiting
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-06-07; most recent amendment 2026-01-26.
Status change: Not Yet Recruiting → Recruiting 2025-04-10
Trial Details
NCT Number NCT06456372
Lead Sponsor University of California, Riverside
Collaborators: University of California, Irvine, Chapman University
Conditions ADHD
Enrollment 60 participants
Start Date 2025-02-22
Primary Completion 2027-09-29 (estimated)
Study Completion 2027-09-29 (estimated)
Updated on ClinicalTrials.gov 2026-01-28