Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456372
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-20
Brief Title:
Digital Health Intervention for Children With ADHD
Sponsor:
University of California Riverside
Organization:
University of California Riverside
Study Overview
Official Title:
Digital Health Intervention for Children With ADHD Improving Mental Health Intervention Patient Experiences and Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n30 or delayed n30 treatment ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None