ADHDNCT05710965
Assessing a Wearable Digital Therapy for Youth With ADHD
A study testing FRx-001, FRx-003 and FRx-004 in people with ADHD, run by Revibe Technologies at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- FRx-001, FRx-003 and FRx-004
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2023to 9 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Show all 23Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Revibe Technologies
Wake Forest, North Carolina, 27587
About this study
Official title: 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).
Read the 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.
- Conditions
- ADHD
- Being tested
- FRx-001, FRx-003, FRx-004
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRx-001Device
Wearable digital therapy
FRx-003Device
Wearable digital therapy
FRx-004Device
Wearable digital therapy
| Study group | Role | What they receive |
|---|---|---|
| FRx-001 | Active comparator | FRx-001 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and scheduled assistive messaging. Receives: Device: FRx-001 |
| FRx-003 | Active comparator | FRx-003 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and may include periodic assistive messaging. Receives: Device: FRx-003 |
| FRx-004 | Active comparator | FRx-004 is a wearable digital intervention that displays periodic therapeutic assistive messaging. Receives: Device: FRx-004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to Post-intervention (4 weeks)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline to Post-intervention (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start15 Feb 2023
- Primary completion9 Jun 2023
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revibe Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710965
- Sponsor's protocol ID
- RV-003
- Status last verified
- Jun 2023
- First submitted
- 11 Jan 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Intervention Study to Assess a Wearable Digital Therapy for Youth With ADHD
- ClinicalTrials.gov ID
- NCT05710965
- Acronym / sponsor ID
- RV-003
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Revibe TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FRx-001 | Active comparator | Device: FRx-001FRx-001 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and scheduled assistive messaging. |
| FRx-003 | Active comparator | Device: FRx-003FRx-003 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and may include periodic assistive messaging. |
| FRx-004 | Active comparator | Device: FRx-004FRx-004 is a wearable digital intervention that displays periodic therapeutic assistive messaging. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRx-001Wearable digital therapy | Device | FRx-001 |
| FRx-003Wearable digital therapy | Device | FRx-003 |
| FRx-004Wearable digital therapy | Device | FRx-004 |
Primary outcome
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.
3 secondary outcomes
ADHD Rating Scale-5, Home Version: Inattention Subscale
Time frame: 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)
ADHD Rating Scale-5, Home Version: Total score
Time frame: Change from Baseline to Post-intervention (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
Related trials for ADHD
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRx-001, FRx-003 and FRx-004 in people with ADHD, run by Revibe Technologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD Rating Scale-5 (ADHD-RS-5), School Version: Inattention Subscale (time frame: Change from Baseline to Post-intervention (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.