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Behavioural Intervention

FRx-001 for Attention Deficit Hyperactivity Disorder (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

Study Summary

This trial looks at how digital devices can help kids with ADHD manage symptoms and improve their functioning.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to post-intervention (4 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to post-intervention (4 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ADHD Rating Scale-5 (ADHD-RS-5), School Version: Inattention Subscale
Secondary outcome measures
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 outcome measures
ADHD Rating Scale-5, Home Version: Hyperactivity-Impulsivity Subscale
ADHD Rating Scale-5, School Version: Hyperactivity-Impulsivity Subscale
Academic Performance Rating Scale
+7 more

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.

Find a Location

Who is running the clinical trial?

Revibe TechnologiesLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study recruiting individuals aged 35 and younger?

"This medical trial is looking for children that are between 8 and 12 years old."

Answered by AI

Are there still places available to join this research endeavor?

"According to the clinicaltrials.gov listing, this medical study is actively collecting participants at present. The research was first submitted on February 15th 2023 and its details were revised most recently that same day."

Answered by AI

What is the total enrollment number for this investigation?

"Correct. Data published on clinicaltrials.gov confirms that this medical study, which was posted initially on February 15th 2023 is actively enrolling participants. 150 patients are needed from 1 research centre."

Answered by AI

Is participation in this clinical experiment open to the public?

"This clinical trial is targeting 150 minors aged 8-12 who have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). All participants must be located in the United States, able to understand and read English at grade level either independently or with adult assistance. Additionally, all youth participating are required to wear a device on their wrist for four weeks during school hours from Monday through Friday. The eligibility criteria includes an ADHD Rating Scale version 5 total score of 28 or greater as determined by parent ratings on the baseline questionnaire; however, those scoring below this threshold may participate but will not included in per protocol analyses."

Answered by AI
~45 spots leftby Apr 2025