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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apollo Neuro device | Experimental | Wearing of activated Apollo Neuro device for at least three hours/day for 30 of 35 consecutive days by Autistic children with SIB and sensory over and/or under responsivity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apollo Neuro device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to wearing the Apollo Neuro Wearable | 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. | 30-35 days |
| Acceptability of Intervention Measure (AIM) | 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. | 30-35 days |
| Feasibility of Intervention Measure (FIM) | 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. | 30-35 days |
| The Repetitive Behavior Scale-Revised (RBS-R) | 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. |
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Inclusion Criteria for child:
Exclusion Criteria for child:
Has medical condition that may increase risk with use of a wearable nibrotactile device, including:
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:
Exclusion Criteria for Caregiver:
• Unable to provide informed consent in English
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Lee Robins | Contact | (757) 285-3486 | robinslp@vcu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stacey Reynolds | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth Uniersity | Richmond | Virginia | 23298 | United States |
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| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
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Feasibility, Quasi-experimental, within subject, pre- and post-test design
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| 30-35 days |
| Change in intensity of self-injurious behavior | 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. | 30-35 days |
| Changes in caregiver-reported SIB intensity | 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. | 30-35 days |
| D001523 | Mental Disorders |