Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 21, 2025
Date Accepted: Jun 6, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
A dual in-person and remote assessment approach to developing digital endpoints relevant to autism and co-occurring conditions: protocol for a multi-site observational study
ABSTRACT
Background:
Research priorities for autistic people include developing effective interventions for the numerous challenges affecting their daily living, e.g., mental health problems, sleep difficulties, and social wellbeing. However, clinical research progress is limited by a lack of validated objective measures that represent target outcomes for improvement. Digital technologies, including wearable devices and smartphone applications, provide opportunities to develop novel measures that may reflect everyday experience and complement key clinical assessments. However, little is known about the acceptability and feasibility of implementing digital data collection in this population.
Objective:
Our objective is to develop novel digital endpoints relevant to key target outcomes, for clinical research, including social communication, sleep, and mental health, using both in-person and remote (i.e., at home) procedures. In particular, this protocol aims to implement and evaluate the usability, acceptability, adherence and feasibility of such procedures, as well as explore the properties of certain resulting measures.
Methods:
Eligible autistic and non-autistic participants in the AIMS Longitudinal European Autism Project (LEAP) were invited to participate in a digitally augmented in-person Autism Diagnostic Observation Schedule-2 (ADOS-2) and a 28-day remote measurement (RM) protocol involving wearing a Fitbit device, downloading a passive smartphone data collection app, and using two active reporting apps.
Results:
The first LEAP study participants were enrolled in September 2021 (in-person component) and March 2022 (RM component). To date, 190 participants have taken part in the digitally augmented ADOS-2 component, and 86 participants have been enrolled for the remote measurement protocol. Recruitment is now complete with some RM data collection ongoing until August 2025. Preliminary data analysis, including exploration of acceptability and feasibility metrics, pipeline development for ADOS-2 speech analysis and RM sleep measures, and framework development for coding qualitative data, has started. Results are expected to be submitted for publication from February 2025.
Conclusions:
This study lays important groundwork in understanding the acceptability and feasibility of in-person and remotely implemented digital measurement procedures to capture meaningful outcomes in domains important to improving everyday life for autistic people.
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