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Completed

NCT Number: NCT05710965

Assessing 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).

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Revibe Technologies

Wake Forest, North Carolina, 27587, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FRx-001

Device

Wearable digital therapy

FRx-003

Device

Wearable digital therapy

FRx-004

Device

Wearable digital therapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Revibe Technologies

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2023
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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