Assessing a Wearable Digital Therapy for Youth With ADHD

Not Applicable

Completed

• Conditions: ADHD
• Interventions: Device: FRx-001; Device: FRx-003; Device: FRx-004

• Registration Number: NCT05710965
• Lead Sponsor: Revibe Technologies

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-02-02
• Study Start: 2023-02-15
• Status Verified: 2023-06
• Primary Completion: 2023-06-09
• Study Completion: 2023-06-09
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FRx-001	FRx-001	FRx-001 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and scheduled assistive messaging.
FRx-003	FRx-003	FRx-003 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and may include periodic assistive messaging.
FRx-004	FRx-004	FRx-004 is a wearable digital intervention that displays periodic therapeutic assistive messaging.

Primary Outcome Measures

Name	Time	Method
ADHD Rating Scale-5 (ADHD-RS-5), School Version: Inattention Subscale	Change from Baseline to Post-intervention (4 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
ADHD Rating Scale-5, Home Version: Total score	Change from Baseline to Post-intervention (4 weeks)	Sum of the parent rated Inattentive and Hyperactivity-Impulsivity Subscale scores. Scores range from 0-54, higher scores indicate greater symptom severity.
ADHD Rating Scale-5, School Version: Total score	Change from Baseline to Post-intervention (4 weeks)	Sum of the teacher rated Inattentive and Hyperactivity-Impulsivity Subscale scores. Scores range from 0-54, higher scores indicate greater symptom severity.
ADHD Rating Scale-5, Home Version: Inattention Subscale	Change from Baseline to Post-intervention (4 weeks)	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.

Trial Locations

Locations (1)

Revibe Technologies; 🇺🇸 Wake Forest, North Carolina, United States