Using Apollo Neuro in Autistic Children With Self-Injurious Behavior

N/ANot Yet RecruitingNCT07648420

Virginia Commonwealth University18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Self-Injurious Behavior Autism Spectrum Disorder

Eligibility

Sex: ALLMin age: 6 YearsMax age: 179 Months

Medical Language ↔ Plain English

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 Exclusion Criteria for Caregiver: • Unable to provide informed consent in English

Outcomes

Primary Outcomes

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.

Time frame: 30-35 days

Acceptability of Intervention Measure (AIM)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 30-35 days

Using Apollo Neuro in Autistic Children With Self-Injurious Behavior

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts