Assessing a Wearable Digital Therapy for Youth With ADHD

June 12, 2023 updated by: Revibe Technologies

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Wake Forest, North Carolina, United States, 27587
        • Revibe Technologies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: FRx-001
FRx-001 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and scheduled assistive messaging.
Device: FRx-001
Wearable digital therapy
Active Comparator: FRx-003
FRx-003 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and may include periodic assistive messaging.
Device: FRx-003
Wearable digital therapy
Active Comparator: FRx-004
FRx-004 is a wearable digital intervention that displays periodic therapeutic assistive messaging.
Device: FRx-004
Wearable digital therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ADHD Rating Scale-5 (ADHD-RS-5), School Version: Inattention Subscale
Time Frame: 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.
Change from Baseline to Post-intervention (4 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ADHD Rating Scale-5, Home Version: Inattention Subscale
Time Frame: 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.
Change from Baseline to Post-intervention (4 weeks)
ADHD Rating Scale-5, School Version: Total score
Time Frame: 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.
Change from Baseline to Post-intervention (4 weeks)
ADHD Rating Scale-5, Home Version: Total score
Time Frame: 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.
Change from Baseline to Post-intervention (4 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ADHD Rating Scale-5, School Version: Hyperactivity-Impulsivity Subscale
Time Frame: Change from Baseline to Post-intervention (4 weeks)
Nine teacher rated items aligned with DSM-5 Hyperactivity-Impulsivity symptoms, scored on a 4-point Likert scale. Scores range from 0-27, higher scores indicate greater symptom severity.
Change from Baseline to Post-intervention (4 weeks)
ADHD Rating Scale-5, Home Version: Hyperactivity-Impulsivity Subscale
Time Frame: Change from Baseline to Post-intervention (4 weeks)
Nine parent rated items aligned with DSM-5 Hyperactivity-Impulsivity symptoms, scored on a 4-point Likert scale. Scores range from 0-27, higher scores indicate greater symptom severity.
Change from Baseline to Post-intervention (4 weeks)
Conners 4, Short Form: Parent
Time Frame: Change from Baseline to Post-intervention (4 weeks)
Parent completed ratings of ADHD symptoms and functioning. Items are rated on a 4-point Likert scale. Subscale raw scores are converted to T-scores with a mean of 50 and standard deviation of 10. Higher scores indicate greater symptom severity or impairment.
Change from Baseline to Post-intervention (4 weeks)
Conners 4, Short Form: Teacher
Time Frame: Change from Baseline to Post-intervention (4 weeks)
Teacher completed ratings of ADHD symptoms and functioning. Items are rated on a 4-point Likert scale. Subscale raw scores are converted to T-scores with a mean of 50 and standard deviation of 10. Higher scores indicate greater symptom severity or impairment.
Change from Baseline to Post-intervention (4 weeks)
Comprehensive Executive Function Inventory: Parent
Time Frame: Change from Baseline to Post-intervention (4 weeks)
Parent completed ratings of a child's executive function. Consists of 9 domains and a total score. Items are rated on a 6-point Likert scale. Subscale raw scores are converted to standard scores with a mean of 100 and standard deviation of 15. Higher scores are indicative of better functioning.
Change from Baseline to Post-intervention (4 weeks)
Comprehensive Executive Function Inventory: Teacher
Time Frame: Change from Baseline to Post-intervention (4 weeks)
Teacher completed ratings of a child's executive function. Consists of 9 domains and a total score. Items are rated on a 6-point Likert scale. Subscale raw scores are converted to standard scores with a mean of 100 and standard deviation of 15. Higher scores are indicative of better functioning.
Change from Baseline to Post-intervention (4 weeks)
Impairment Rating Scale - Parent
Time Frame: Change from Baseline to Post-intervention (4 weeks)
Parent completed ratings of impairment in youth with ADHD. Parent version includes 8 items. The 8th represents overall impairment. Ratings are made on a 7-point Likert scale from "no problem/definitely does not need treatment or special services" to "extreme problem/definitely needs treatment or special services". Higher scores indicate more severe problems.
Change from Baseline to Post-intervention (4 weeks)
Impairment Rating Scale - Teacher
Time Frame: Change from Baseline to Post-intervention (4 weeks)
Teacher completed ratings of impairment in youth with ADHD. Teacher version includes 7 items. The 7th represents overall impairment. Ratings are made on a 7-point Likert scale from "no problem/definitely does not need treatment or special services" to "extreme problem/definitely needs treatment or special services". Higher scores indicate more severe problems.
Change from Baseline to Post-intervention (4 weeks)
Weiss Functional Impairment Rating Scale - Parent Form
Time Frame: Change from Baseline to Post-intervention (4 weeks)
Parent completed ratings of child's overall functioning across six domains including a total score. Items are rated on a 4-point Likert scale ranging from "not at all or never" to "very much or very often", as well as a "not applicable" option. Higher scores are associated with impairment.
Change from Baseline to Post-intervention (4 weeks)
Academic Performance Rating Scale
Time Frame: Change from Baseline to Post-intervention (4 weeks)
A 19-items scale developed to reflect teachers' perceptions of children'ts academic performance and abilities in classroom settings. Items are rated on a 5-point Likert scale, and scores are summed for each of the factor scores: Academic Success, Impulse Control, and Academic Productivity. A total score is also calculated for overall academic performance. Higher scores are representative of stronger classroom functioning.
Change from Baseline to Post-intervention (4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Revibe Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 9, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RV-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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