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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 12
Healthy Volunteers: f
View:

• DSM-5TR diagnosis of ADHD through prior medical or psychological evaluations at the time of admission to the program,

• ability to complete questionnaires and use an app in English,

• reported IQ of at least 80 in order to ensure that the participant has the cognitive skills needed to use the app, and

• parent/guardian available to consent and provide feedback in English.

Locations
United States
California
The Craig School
RECRUITING
Irvine
UCR Psychiatry at Grindstaff Community School
RECRUITING
Riverside
Contact Information
Primary
Jaime Smith
jaime.smith@medsch.ucr.edu
951-827-0741
Backup
Kimberley Lakes
kimberley.lakes@medsch.ucr.edu
951-827-2410
Time Frame
Start Date: 2025-02-22
Estimated Completion Date: 2027-09-29
Participants
Target number of participants: 60
Treatments
No_intervention: Treatment as Usual
Experimental: Digital Health Intervention Group
Sponsors
Leads: University of California, Riverside
Collaborators: University of California, Irvine, Chapman University

This content was sourced from clinicaltrials.gov