A Dual In-Person and Remote Assessment Approach to Developing Digital End Points Relevant to Autism and Co-Occurring Conditions: Protocol for a Multisite Observational Study.

Background: Research priorities for autistic people include developing effective interventions for the numerous challenges affecting their daily living, for example, mental health problems, sleep difficulties, and social well-being. 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 apps, 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: The primary objective of this study is to evaluate the usability, acceptability, adherence, and feasibility of a dual in-person and remote (ie, at-home) protocol. Secondarily, we aim to explore the properties of certain resulting data with a view to developing novel digital end points for key target outcomes, including social communication, sleep, and mental health.

Methods: Eligible autistic and nonautistic in the AIMS Longitudinal European Autism Project 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 2 active reporting apps.

Results: The first AIMS Longitudinal European Autism Project 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 RM protocol. Recruitment is now complete with some RM data collection ongoing until August 2025. Data analysis has commenced, including qualitative framework analysis of feedback interview data coproduced with autism community members, exploration of acceptability and feasibility metrics, pipeline development for ADOS-2 speech analysis, and RM sleep measures.

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.

International registered report identifier (irrid): DERR1-10.2196/71145.