Digital Health Intervention for Children With ADHD

University of California (UC), Riverside

Status

Enrolling

Conditions

ADHD

Treatments

Behavioral: Digital Health Intervention Group

Study type

Interventional

Funder types

Other

Identifiers

NCT06456372

R21HS028871/R33HS028871

R21HS028871 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

8 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria