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Behavioural Intervention
Assessing a Wearable Digital Therapy for Youth With ADHD
N/A
Waitlist Available
Research Sponsored by Revibe Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to post-intervention (4 weeks)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing three different wearable devices to see if they can help children with ADHD improve their focus and behavior at school. The children will wear these devices for a period of time, and their progress will be monitored by parents and teachers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to post-intervention (4 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to post-intervention (4 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
ADHD Rating Scale-5 (ADHD-RS-5), School Version: Inattention Subscale
Secondary study objectives
ADHD Rating Scale-5, Home Version: Inattention Subscale
ADHD Rating Scale-5, Home Version: Total score
ADHD Rating Scale-5, School Version: Total score
Other study objectives
ADHD Rating Scale-5, Home Version: Hyperactivity-Impulsivity Subscale
ADHD Rating Scale-5, School Version: Hyperactivity-Impulsivity Subscale
Academic Performance Rating Scale
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: FRx-001Active Control1 Intervention
FRx-001 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and scheduled assistive messaging.
Group II: FRx-003Active Control1 Intervention
FRx-003 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and may include periodic assistive messaging.
Group III: FRx-004Active Control1 Intervention
FRx-004 is a wearable digital intervention that displays periodic therapeutic assistive messaging.
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Who is running the clinical trial?
Revibe TechnologiesLead Sponsor