Autism Spectrum Disorder, Self-Injurious Behavior
Conditions
Keywords
Apollo Neuro Device, Sensory Responsivity, Autonomic Regulation, Wearable Device, Vibrotactile Stimulation
Brief summary
This study will evaluate the feasibility and acceptability of the Apollo Neuro, a wearable vibrotactile sensory device, in autistic children who engage in self-injurious behavior (SIB). Participants will wear the device for at least 3 hours per day over a 30-35 day period with caregiver support. Outcomes will include adherence to device use, caregiver-reported feasibility and acceptability, and descriptive characterization of caregiver-reported self- injurious and repetitive behaviors during the study period. This preliminary, single-group study is not designed to evaluate efficacy and will inform the design of future controlled trials.
Detailed description
who engage in self-injurious behavior (SIB). Participants will wear the device for at least 3 hours per day over a 30-35 day period with caregiver support. Outcomes will include adherence to device use, caregiver-reported feasibility and acceptability, and descriptive characterization of caregiver-reported self-injurious and repetitive behaviors during the study period. This preliminary, single-group study is not designed to evaluate efficacy and will inform the design of future controlled trials.
Interventions
DEVICEApollo Neuro device
Child participants will wear the activated device for a minimum of three hours per day on at least 30 of 35 consecutive days, consistent with the study protocol. The device is worn externally (e.g., wrist, ankle, or waist) and delivers low intensity vibrations through intact skin.
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Feasibility, Quasi-experimental, within subject, pre- and post-test design
Eligibility
Sex/Gender
ALL
Age
6 Years to 179 Months
Healthy volunteers
No
Inclusion criteria
for child: * Diagnosis of autism spectrum disorder (ASD), as reported by caregiver * Presence of self-injurious behavior, as reported by caregiver * Demonstrates sensory over and/or under- responsivity * Aged 6 years to 14 years, 11 months (179 months) at the time of enrollment * Has a caregiver willing and able to provide consent and participate in study procedures
Exclusion criteria
for child: * Has medical condition that may increase risk with use of a wearable nibrotactile device, including: * implanted medical or neurological devices (e.g., pacemaker) * significant cardiac conditions or arrhythmias * history of syncope (fainting) * Known seizure disorder without physician clearance * Regular use of nibrotactile or autonomic- modulating wearable devices within the past 90 days * Any condition that, in the judgment of the investigator, would interfere with safe participation or interpretation of study procedures Inclusion Criteria for Caregiver: * Parent or legal guardian of the enrolled child participant * Able to provide informed consent in English * Able and willing to support device use according to study protocol and complete study-related data collection * Has access to a smartphone or compatible device capable of operating the Apollo Neuro application for the duration of study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to wearing the Apollo Neuro Wearable | 30-35 days | Caregiver-reported acceptability of the intervention, as measured by the Acceptability of Intervention Measure (AIM), a validated 4-item instrument assessing the perceived agreeableness, satisfaction, and usability of the intervention. Each item is rated on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). Responses will be summarized descriptively using mean scores and response distributions. |
| Acceptability of Intervention Measure (AIM) | 30-35 days | Caregiver-reported acceptability of the intervention, as measured by the Acceptability of Intervention Measure (AIM), a validated 4-item instrument assessing the perceived agreeableness, satisfaction, and usability of the intervention. Each item is rated on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). Responses will be summarized descriptively using mean scores and response distributions. |
| Feasibility of Intervention Measure (FIM) | 30-35 days | Caregiver-reported feasibility of the intervention, as measured by the Feasibility of Intervention Measure (FIM), a validated 4-item instrument assessing the extent to which the intervention can be successfully implemented within the home setting. Each item is rated on a 5-point Likert scale ranging from 1(Completely disagree) to 5 (Completely agree). Responses will be summarized descriptively using mean scores and response distributions. |
| The Repetitive Behavior Scale-Revised (RBS-R) | 30-35 days | Caregiver-reported behaviors, as measured by the Repetitive Behavior Scale-Revised (RBS-R), a validated 43-item questionnaire assessing the presence and severity of restricted and repetitive behaviors in individuals with autism spectrum disorder, including self-injurious behavior. The measure is completed by caregivers at baseline and post-intervention using a 4-point Likert scale. Scores will be summarized descriptively to characterize patterns over the study period. |
| Change in intensity of self-injurious behavior | 30-35 days | Changes in the intensity of self-injurious behavior associated with the use of the Apollo Neuro wearable device will be measured by caregiver-reported tracking daily ratings of peak self-injurious behavior intensity on a study designed form tracking the participant adherence. |
| Changes in caregiver-reported SIB intensity | 30-35 days | Daily caregiver-reported ratings of peak self-injurious behavior intensity, measured using a visual analog scale (VAS) recorded on a study-designed data collection form. Caregivers will provide ratings each day throughout the intervention period. Data will be summarized descriptively to characterize variability and patterns over time. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStacey Reynolds
Virginia Commonwealth University
CONTACTLaura Lee Robins
Outcome results
None listed