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NCT07648420

Using Apollo Neuro in Autistic Children With Self-Injurious Behavior

Not Yet Recruiting
NAAges 6+Interventional
Virginia Commonwealth University
~18 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Apollo Neuro device

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adherence to wearing the Apollo Neuro Wearable
Measured over 30-35 days
+5 more outcomes measured

Conditions

Self-Injurious Behavior
Autism Spectrum Disorder

Explore related trials

Autism Spectrum DisorderSelf-injurious behavior

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Stacey Reynolds · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

Who to contact

Laura Lee Robins
[email protected]
(757) 285-3486
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Eligibility criteria

Inclusion

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
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

Exclusion

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

What this trial measures

  • Adherence to wearing the Apollo Neuro Wearable30-35 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 behavior30-35 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 intensity30-35 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.