ASD Wearables Feasibility Study

Feasibility of Wearable Devices as a Source of Data to Support HealthAI in Autism Spectrum Disorder Populations

The goal of this clinical study is to evaluate and compare the feasibility of wearable device use among pediatric participants with autism spectrum disorder (ASD) across four different wearable device form factors: a wristband, headband, adhesive patch, and finger ring. Rather than investigating health or clinical outcomes associated with wearable device use, the study focuses on comparative assessment of device types to determine which forms are most acceptable and practical for this population.

The study explores factors that may influence feasibility, including comfort, wearability, sustained use, and participant and caregiver engagement. The main questions the study aims to answer are:

• Were adolescents with ASD able to tolerate wearing the assigned device for the full two-week study period?
• Did adolescents with ASD and their caregivers consider the wearable device to be comfortable and usable?
• Were there any unanticipated factors that affected the feasibility of wearable device use among youth with ASD?

Researchers will compare data collected across device groups to determine (1) which form factor performed most effectively in real-world settings, and (2) which design characteristics are most important to consider when developing or selecting wearable devices intended for safe, acceptable, and sustained use in adolescent ASD populations.

Adolescent participants and their caregivers will:

• Be asked to complete four research visits (two in-person and two virtual video visits)
• Complete multiple questionnaires (caregivers), assessments (adolescents) and two semi-structured interviews
• Wear the assigned wearable device, as instructed, for a two-week trial: either a headband, wristband, adhesive patch, or finger ring

Wearable devices are increasingly used to support clinical research and caregiver decision-making; however, individuals with autism spectrum disorder (ASD) may experience unique challenges related to wearable device use. Sensory sensitivities and responses to physical stimuli may affect the tolerability, comfort, and sustained use of wearable technologies in this population. As a result, understanding how adolescents with ASD interact with and perceive different wearable device designs is an important step in selecting and developing devices suitable for real-world use.

This clinical study is a comparative evaluation of wearable device use across four different device form factors-a wristband, headband, adhesive patch, and finger ring-under real-world conditions in adolescents with ASD. The study examines feasibility-related factors, including device tolerability, comfort, usability, and wearability over a two-week study period. Participants are assigned to a single device type, and data are collected to assess their experiences using the assigned wearable during daily activities.

Rather than focusing on physiological mechanisms or evaluating clinical or health outcomes, this study is designed to generate comparative information on how different wearable device designs are experienced by pediatric participants with ASD. Findings from this study are intended to inform future research, development, and selection of wearable technologies that are acceptable, practical, and suitable for use in adolescent ASD populations.

Event Overview:

Study Visit #1: Day 1 (90 min)

• Virtual e-consent for adolescent and caregiver assent and consent
• Virtual semi-structured interview #1
• Device assignment

Study Visit #2: Day 2 (60 minutes)

• In person participant assessment
• NIH toolbox V2 Cognitive & Emotional Assessment Batteries
• In person caregiver assessments:
• Short Sensory Profile-2 (SSP-2)
• Social Responsiveness Scale (SRS-2)
• Child Behavior Checklist (CBCL)
• Medical history questionnaire
• Receive allocated device assignment
• Priming: Social Story - Participants will be introduced to their wearable device via a social story to prepare them to better understand and manage their involvement in the study.
• 1st $25 compensation installment

Days 3-16

• Adolescent will wear the wearable device for 2 weeks
• During the two weeks, usage will be tracked by a researcher who may contact participants to intervene if no data are being collected

Study Visit #3: Day 17

• Virtual semi-structured interview #2
• Caregiver assessments
• System Usability Scale (SUS)
• Comfort Rating Scale (CRS)

Study Visit #4: Day 18

• Return device to study
• 2nd $25 compensation installment

Inclusion Criteria:

• Provision of signed and dated informed consent and assent forms
• Stated willingness to comply with all study procedures
• Stated availability for the duration of the study
• Parent provided diagnosis of autism spectrum disorder confirmed via formalized assessment

Exclusion Criteria:

• Presence of acute psychiatric symptoms, such as:

  1. Suicidal ideation (SI)
  2. Homicidal ideation (HI) During the prescreening call, the researcher will ask the prospective adolescent participant, "Do you have thoughts of harming yourself or others?" and if yes, the researcher will contact the PI and contact 911 depending on acuity of situation.