NCT06456372

Digital Health Intervention for Children With ADHD

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of California, Riverside · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ADHD

Interventions

Type	Name	Description
BEHAVIORAL	Digital Health Intervention Group	Our digital health intervention (DHI) uses Patient-Centered Digital Healthcare Technologies (PC-DHT) to promote co-regulation (child/parent), capture patient data, support efficient healthcare delivery, enhance patient engagement, and facilitate shared decision-making, thereby improving access to timely and targeted mental health intervention for children at great risk for poor outcomes. This system will integrate treatment across multiple points of care and will enable health care providers and caregivers to share reliable and targeted information that will facilitate collaborative decision-making (e.g., making decisions about changing or titrating medications/dosages or shifting behavioral therapy and educational intervention targets) and improve patient experiences and outcomes.

Timeline

• Start date: 2025-02-22
• Primary completion: 2027-09-29
• Completion: 2027-09-29
• First posted: 2024-06-13
• Last updated: 2026-01-28

Locations

2 sites across 1 country: United States