Assessing anxiety in adolescents with autism spectrum disorder (ADORA): developing a health equity protocol for non-invasive biomarkers

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INTRODUCTION: Identifying anxiety disorders in autistic youth can be challenging due to the unique presentation of anxiety symptoms in autistic youth and the difficulties youth may have reporting on their own anxiety symptoms. These challenges underscore the need for objective and reliable measures. Understanding whether autonomic activity is associated with the presence of anxiety may lead to its use as an objective anxiety assessment tool in individuals who may otherwise struggle to communicate their feelings of anxiety. Most published studies examining autonomic activity and anxiety in autistic individuals lack information regarding racial demographic information, and those that do are predominantly composed of White individuals. These findings highlight the critical need for future research that includes more diverse samples and uses consistent, ecologically valid methods to examine the relation between anxiety and autonomic activity in autistic populations. This study aims to recruit a large sample of racially diverse adolescents to evaluate whether atypical autonomic activity serves as a biomarker of anxiety in autistic and non-autistic youth. This manuscript outlines the recruitment strategies for this study protocol, providing a framework for understanding the interplay between physiological, psychological and contextual factors including self-identified race in anxiety among autistic and non-autistic adolescents. METHODS AND ANALYSIS: Autistic (n=80) and non-autistic (n=80) adolescents aged 11-14 years and their caregivers will be invited to participate in the current study. Autism diagnosis will be confirmed by gold-standard assessments. All participants will complete an in-person visit assessing their child's cognitive abilities and trait-level anxiety and mental health symptoms, learn how to wear a non-invasive heart rate band that will collect ECG and respiration data, complete a 5-minute in-lab baseline of autonomic activity and enroll in experience sampling. Next, participants will complete three 5-minute baselines of autonomic activity at home, followed by 5 days of wearing the heart rate band for 5 hours per day, overlapping with ecological momentary assessment of their mood. Primary outcome measures include trait-level parent and self-reports of anxiety, real-time self-reports of anxiety captured through ecological momentary assessment, and both baseline and in-the-moment heart rate variability. ETHICS AND DISSEMINATION: The study protocol has been approved by the University of Maryland's Institutional Review Board. Results will be disseminated through peer-reviewed publications and conferences. Deidentified data from participants who consent to have their data shared with other researchers will be uploaded to the National Data Archive Collection C5316.

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