Assessing a Wearable Digital Therapy for Youth With ADHD

Study Overview
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Brief Summary
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The purpose of this study is to evaluate and compare three different investigational wearable digital interventions to determine if they are helpful for improving symptoms and functioning in children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

Detailed Description
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The study is a randomized controlled trial of three investigational wearable digital therapies. An online screening questionnaire will evaluate eligibility for the study. Parents and teachers will complete baseline measures, after which the child will wear the assigned device to school Monday-Friday for a four-week period. Parents and teachers will complete the measures again at the end of the four-week intervention period. Compliance with wearing the device will be monitored remotely.

Official Title
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A Randomized Controlled Intervention Study to Assess a Wearable Digital Therapy for Youth With ADHD

Conditions
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ADHD

Intervention / Treatment
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* Device: FRx-001
* Device: FRx-003
* Device: FRx-004


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Youth Participants Parent-reported diagnosis of ADHD Must be between the ages of 8 and 12 years of age Must live in the United States Must be able to understand English well Must be able to read English well (reading at grade level independently or with adult assistance) Must be attending in-class (as opposed to hybrid or virtual) school during the period of the trial Must be willing to wear the device to school on their wrist Monday to Friday for a period of four-weeks Parent-rated ADHD-RS-5 Total score of ≥ 28* The ADHD-RS-5 score will be determined based on the ratings provided in the parent baseline questionnaire. Any youth with a parent-rated Total score <28 will be allowed to remain in the study but will not be included in the per protocol analyses. Parent Participants Must be 18 years of age or older Must be willing to invite the child's teacher to participate Must live in the United States Must read and understand English well Must have a mobile device that can be used to download and install the software application and sync to the device Must be willing to have their child wear the device to school Monday to Friday for a period of four weeks and sync and charge the device Teacher Participants Must be 18 years of age or older Must live in the United States Must have known the student for at least four weeks Must read and understand English well Must be providing in person classroom learning to the youth during the study period Exclusion Criteria: Youth Participants Motor condition (e.g., physical deformity of the hands/arms; prostheses) that prevents tapping the device if prompted or unable to feel vibrations from the device on their wrist (should there be any), as reported by the parent. Home schooled Diagnosed (parent-reported) Autism Spectrum Disorder, Intellectual Disability, Pervasive Developmental Disorder, Schizophrenia Spectrum Disorder. Not undergoing pharmacological treatment for ADHD (currently or in the past 30 days) Has ever worn or used Revibe Connect prior to the study or has a sibling who has Has ever participated in a research study conducted by Revibe Technologies or has a sibling who has Has a sibling participating in the study. Only one child per family is eligible to participate. Allergy to latex (parent-reported) Parent and Teacher Participants • No exclusion criteria other than not meeting the inclusion criteria

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FRx-001<br>FRx-001 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and scheduled assistive messaging. | Device: FRx-001<br>* Wearable digital therapy<br>|
| Active Comparator: FRx-003<br>FRx-003 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and may include periodic assistive messaging. | Device: FRx-003<br>* Wearable digital therapy<br>|
| Active Comparator: FRx-004<br>FRx-004 is a wearable digital intervention that displays periodic therapeutic assistive messaging. | Device: FRx-004<br>* Wearable digital therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD Rating Scale-5 (ADHD-RS-5), School Version: Inattention Subscale | Nine teacher rated items aligned with Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) Inattentive symptoms, scored on a 4-point Likert scale from never or rarely to very often. Scores range from 0-27, higher scores indicate greater symptom severity. | Change from Baseline to Post-intervention (4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD Rating Scale-5, Home Version: Inattention Subscale | Nine parent rated items aligned with DSM-5 Inattentive symptoms, scored on a 4-point Likert scale from never or rarely to very often. Scores range from 0-27, higher scores indicate greater symptom severity. | Change from Baseline to Post-intervention (4 weeks) | 
| ADHD Rating Scale-5, School Version: Total score | Sum of the teacher rated Inattentive and Hyperactivity-Impulsivity Subscale scores. Scores range from 0-54, higher scores indicate greater symptom severity. | Change from Baseline to Post-intervention (4 weeks) | 
| ADHD Rating Scale-5, Home Version: Total score | Sum of the parent rated Inattentive and Hyperactivity-Impulsivity Subscale scores. Scores range from 0-54, higher scores indicate greater symptom severity. | Change from Baseline to Post-intervention (4 weeks) |