Recruiting

Digital Health Intervention

Sponsor:

UCLA

Code:

NCT06456372

Conditions

ADHD

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

Interventions

Digital Health Intervention Group

Study Details

Brief 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

Study ID

NCT06456372

Start date

Feb 22, 2025

Status verified date

Jan, 2026

Completion date

Sep 29, 2027

Anticipated

Primary completion date

Sep 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. DSM-5TR diagnosis of ADHD through prior medical or psychological evaluations at the time of admission to the program,
2. ability to complete questionnaires and use an app in English,
3. reported IQ of at least 80 in order to ensure that the participant has the cognitive skills needed to use the app, and
4. parent/guardian available to consent and provide feedback in English.

Exclusion Criteria:

  • Failure to meet any of the inclusion criteria

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Treatment as Usual

experimental: Digital Health Intervention Group

Interventions

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.

Primary outcome measure

  • Child Self-Regulation - BASC-3 SRP, PRS, TRS [ Time Frame: 1 Year ]
  • ADHD Symptoms - BASC-3 SRP, PRS, TRS [ Time Frame: 1 Year ]
  • ADHD Symptoms - Brown EF/A [ Time Frame: 1 Year ]
  • ADHD Symptoms - SWAN [ Time Frame: 1 Year ]
  • Parent Self-Regulation - BASC-3 PRQ [ Time Frame: 1 Year ]
  • Engagement in Care - PAM Child [ Time Frame: 1 Year ]
  • Engagement in Care - PAM Parent [ Time Frame: 1 Year ]
  • Perceptions of Shared-Decision Making and Treatment Collaborations - Child & Parent [ Time Frame: 1 Year ]
  • Perceptions of Shared-Decision Making and Treatment Collaborations - Provider/Educator [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Jaime Smith

951-827-0741jaime.smith@medsch.ucr.edu

Kimberley Lakes

951-827-2410kimberley.lakes@medsch.ucr.edu

Locations

The Craig School

Recruiting

Irvine, California, United States, 92612

Contacts

Nancy Herrera, PhD

nancy.herrera@medsch.ucr.edu

Principal Investigator:

Sabrina Schuck, PhD

UCR Psychiatry at Grindstaff Community School

Recruiting

Riverside, California, United States, 92503

Contacts

Nancy Herrera, PhD

nancy.herrera@medsch.ucr.edu

Principal Investigator:

Kimberley Lakes, PhD

More Information

Sponsor

University of California, Riverside

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Riverside on 2026-01-28.