Clinical trial NCT05710965: Assessing a Wearable Digital Therapy for Youth With ADHD
Official title: A Randomized Controlled Intervention Study to Assess a Wearable Digital Therapy for Youth With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: Revibe Technologies
Sponsor class: INDUSTRY
First posted: 2023-02-02
Enrollment: 97
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: ADHD Rating Scale-5 (ADHD-RS-5), School Version: Inattention Subscale
timeFrame: Change from Baseline to Post-intervention (4 weeks)
Secondary outcomes:
measure: ADHD Rating Scale-5, Home Version: Inattention Subscale
timeFrame: Change from Baseline to Post-intervention (4 weeks)
measure: ADHD Rating Scale-5, School Version: Total score
timeFrame: Change from Baseline to Post-intervention (4 weeks)
measure: ADHD Rating Scale-5, Home Version: Total score
timeFrame: Change from Baseline to Post-intervention (4 weeks)
Other outcomes:
measure: ADHD Rating Scale-5, School Version: Hyperactivity-Impulsivity Subscale
timeFrame: Change from Baseline to Post-intervention (4 weeks)
measure: ADHD Rating Scale-5, Home Version: Hyperactivity-Impulsivity Subscale
timeFrame: Change from Baseline to Post-intervention (4 weeks)
measure: Conners 4, Short Form: Parent
timeFrame: Change from Baseline to Post-intervention (4 weeks)
measure: Conners 4, Short Form: Teacher
timeFrame: Change from Baseline to Post-intervention (4 weeks)
measure: Comprehensive Executive Function Inventory: Parent
timeFrame: Change from Baseline to Post-intervention (4 weeks)
measure: Comprehensive Executive Function Inventory: Teacher
timeFrame: Change from Baseline to Post-intervention (4 weeks)
measure: Impairment Rating Scale - Parent
timeFrame: Change from Baseline to Post-intervention (4 weeks)
measure: Impairment Rating Scale - Teacher
timeFrame: Change from Baseline to Post-intervention (4 weeks)
measure: Weiss Functional Impairment Rating Scale - Parent Form
timeFrame: Change from Baseline to Post-intervention (4 weeks)
measure: Academic Performance Rating Scale
timeFrame: Change from Baseline to Post-intervention (4 weeks)
Locations:
city: Wake Forest
country: United States
facility: Revibe Technologies
state: North Carolina
Study officials:
References: