ASD Wearables Feasibility Study

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

Conditions

• Autism Spectrum Disorder
• Wearable Devices

Interventions

DEVICE

14-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 & Collaborators

• Rady Children's Hospital, San Diego

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Rady Pediatric Genomics & Systems Medicine Institute

  lead OTHER

Principal Investigators

• Aaron Besterman, M.D. · Rady Children's Institute for Genomic Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-15

Primary Completion

2025-12-18

Completion

2026-01-06

Countries

• United States

Study Locations