MedTrace Logo

Digital Health Intervention for Children With ADHD

NCT06456372 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of California, Irvine

    collaborator OTHER

  • Chapman University

    collaborator OTHER

  • University of California, Riverside

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-22
Primary Completion
2027-09-29
Completion
2027-09-29

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06456372 on ClinicalTrials.gov