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).

Inclusion Criteria:Youth ParticipantsParent-reported diagnosis of ADHDMust be between the ages of 8 and 12 years of ageMust live in the United StatesMust be able to understand English wellMust 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 trialMust be willing to wear the device to school on their wrist Monday to Friday for a period of four-weeksParent-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 ParticipantsMust be 18 years of age or olderMust be willing to invite the child's teacher to participateMust live in the United StatesMust read and understand English wellMust have a mobile device that can be used to download and install the software application and sync to the deviceMust 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 deviceTeacher ParticipantsMust be 18 years of age or olderMust live in the United StatesMust have known the student for at least four weeksMust read and understand English wellMust be providing in person classroom learning to the youth during the study periodExclusion Criteria:Youth ParticipantsMotor 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 schooledDiagnosed (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 hasHas ever participated in a research study conducted by Revibe Technologies or has a sibling who hasHas 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