Digital Health Intervention for Children With ADHD

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Riverside
Study ID
NCT06456372
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Digital Health Intervention Group — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Feb 22, 2025
Status verified
Jan 2026
Primary completion
Sep 29, 2027
Completion
Sep 29, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Treatment as Usual
  • Experimental: Digital Health Intervention Group

Primary Outcome Measure

Child Self-Regulation - BASC-3 SRP, PRS, TRS [ Time Frame: 1 Year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Craig SchoolIrvineCalifornia92612
Nancy Herrera, PhD
[email protected]
Sabrina Schuck, PhD (PRINCIPAL_INVESTIGATOR)
UCR Psychiatry at Grindstaff Community SchoolRiversideCalifornia92503
Nancy Herrera, PhD
[email protected]
Kimberley Lakes, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

By condition
ADHD
By specialty
PsychiatryMental healthBehavioral health
By research site
The Craig School· Irvine, CAUCR Psychiatry at Grindstaff Community School· Riverside, CA

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