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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FRx-001 | Active Comparator | FRx-001 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and scheduled assistive messaging. |
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| 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. |
|
| FRx-004 | Active Comparator | FRx-004 is a wearable digital intervention that displays periodic therapeutic assistive messaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FRx-001 | Device | Wearable digital therapy |
| |
| FRx-003 |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| ADHD Rating Scale-5, School Version: Hyperactivity-Impulsivity Subscale | 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 |
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*
Parent Participants
Teacher Participants
Exclusion Criteria:
Youth Participants
Parent and Teacher Participants
• No exclusion criteria other than not meeting the inclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Revibe Technologies | Wake Forest | North Carolina | 27587 | United States |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Device |
Wearable digital therapy |
|
| FRx-004 | Device | Wearable digital therapy |
|
| 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) |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) |