Assessing a Wearable Digital Therapy for Youth With ADHD

NCT05710965 | Completed

• 1 other identifier: RV-003
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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).

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• ADHD Rating Scale-5, Home Version: Inattention Subscale

  Change from Baseline to Post-intervention (4 weeks)

• ADHD Rating Scale-5, School Version: Total score

  Change from Baseline to Post-intervention (4 weeks)

• ADHD Rating Scale-5, Home Version: Total score

  Change from Baseline to Post-intervention (4 weeks)

Other Outcomes (10)

• ADHD Rating Scale-5, School Version: Hyperactivity-Impulsivity Subscale

  Change from Baseline to Post-intervention (4 weeks)

• ADHD Rating Scale-5, Home Version: Hyperactivity-Impulsivity Subscale

  Change from Baseline to Post-intervention (4 weeks)

• Conners 4, Short Form: Parent

  Change from Baseline to Post-intervention (4 weeks)

Study Arms (3)

FRx-001

ACTIVE COMPARATOR

FRx-001 is a wearable digital intervention that provides therapeutic vibrations to the subjects wrist and scheduled assistive messaging.

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.

Device: FRx-003

FRx-004

ACTIVE COMPARATOR

FRx-004 is a wearable digital intervention that displays periodic therapeutic assistive messaging.

Device: FRx-004

Interventions

FRx-001 DEVICE

Wearable digital therapy

FRx-001

FRx-003 DEVICE

Wearable digital therapy

FRx-003

FRx-004 DEVICE

Wearable digital therapy

FRx-004

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Revibe Technologies: lead

Study Sites (1)

Revibe Technologies

Wake Forest, North Carolina, 27587, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 2, 2023
• Study Start: February 15, 2023
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

US (1)