Autism Spectrum Disorder, Wearable Devices
Conditions
Keywords
autism spectrum disorder, adolescents, feasibility, wearable, device, form factor, tolerability, comparison
Brief summary
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
Detailed description
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
Interventions
DEVICE14-Day Device Monitoring
Adolescents will receive a wearable device, of the form factor device group (wristband, headband, adhesive patch, ring) they were sequentially assigned to at enrollment, to wear for a consecutive period of 14 days. Participants will be asked to go about their daily life normally with awareness of the wearable device requirements and limits specific to their assigned study arm. Researchers will remotely monitor the data collected by these wearable devices and intervene during this two-week trial if no data is being obtained.
Sponsors
Rady Pediatric Genomics & Systems Medicine Institute
Rady Children's Hospital, San Diego
University of California, San Diego
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants were assigned to one of four wearable device groups using a prespecified, non-random alternating assignment based on sequence of enrollment. Device assignment alternated across the four device types such that Participant 1 received Device 1, Participant 2 received Device 2, Participant 3 received Device 3, Participant 4 received Device 4, and the sequence repeated until 10 participants were assigned to each device group (N = 40 total).
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Wear Adherence (Data Completeness) | 2 weeks | A device-specific data completeness score will be calculated for each participant as a measure of adherence to the device wear protocol. Completeness is defined as the percentage of expected wear time during which valid device data were successfully recorded. Expected daily wear duration was defined as 24 hours for the wristband and adhesive patch, and 8 hours for the headband and finger ring. For devices with an 8-hour expected wear period, days with 8 or more hours of valid data were considered 100% complete. Completeness scores will be summarized by device type to compare adherence across wearable form factors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Wear Adherence (Complete Expected Periods) | 2 weeks | To account for differences in expected period of device wear (night-only vs continuous) Complete Expected Periods is effectively a discretized version of Completeness that segments time into Day and Night periods. Day Period: A 14-hour window from 08:00 to 22:00. Night Period: A 10-hour window from 22:00 to 08:00. A given period was considered "complete" if the number of minutes that contained valid data exceeded a common threshold for data inclusion. This corresponded to 600 minutes (10 hours) of data for the day period, and 360 minutes (6 hours) for the night period. For the headband and ring, only night periods were expected, so 6 hours of data over a 24-hour period (12pm-12pm) was considered "complete". |
| Device Comfort | 2 weeks | The Comfort Rating Scale (CRS; Knight et al., 2002) will be used to measure adolescent and caregiver perceptions of the comfortability of the assigned wearable device. Scores are aggregated to identify specific aspects of the device that may cause discomfort, facilitating targeted design improvements for wearable systems. |
| Device Usability | 2 weeks | The System Usability Scale (SUS; Brooke, 1996) will be used to measure adolescent and caregiver perceptions of the usability of each device and corresponding data capturing system. To calculate the SUS score, individual item scores are transformed and summed to produce a single value ranging from 0 to 100. This score represents a composite measure of the overall usability of the system being studied. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAaron Besterman, M.D.
Rady Children's Institute for Genomic Medicine
Outcome results
None listed