- Awarded: 2019
- Award Type: Targeted: Novel Outcome Measures for ASD Clinical Trials
- Award #: 640723
Autism spectrum disorder (ASD) is characterized by impairments in social communication/interaction (SCI) and the presence of restricted/repetitive behaviors (RRB) and is often accompanied by language impairment. At present, subjective assessment tools are the only methods available for ASD identification and symptom tracking, including parent interview, clinician observation and ratings, and informant-completed questionnaires. These methods have significant limitations including: subjectivity, rater bias, the need for specialized training and ongoing reliability checks, in addition to requiring a substantial time investment for affected individuals and clinical staff. Thus, there is a great need for quantitative, objective measures to improve the identification of clinical symptomatology and track symptom change.
The current study involves a multisite, large sample, cross-sectional and longitudinal evaluation of quantitative, objective gaze-based indices using a screening test, called AutismEYES, that was first developed by Tom Frazier and colleagues1, 2. Three sites (University of Missouri, Stanford University and University of Virginia, led by Stephen Kanne, Antonio Hardan and Micah Mazurek, respectively) will collect remote eye-gaze and clinical data cross-sectionally from 300 children (ages 2-17 years) presenting for evaluation of ASD to test SCI deficits and RRB. A subset of the ASD-diagnosed children (approximately 100) will be longitudinally studied with follow-ups at 2- and 16-weeks post-baseline to evaluate test-retest reliability and sensitivity to change of gaze-based indices. Finally, using data from three funded, ongoing clinical trials (vasopressin, minocycline and cannabidiol studies in children/adults with ASD), the researchers will also explore the sensitivity of gaze indices to treatment-mediated improvements.
The proposed study is innovative and potentially has great significance by attempting to validate a remote eye-gaze-tracking tool as a measure for tracking ASD symptom severity (SCI and RRB) during longitudinal studies and clinical trials. There is a need for quantitative, objective measures that are cost effective, easy to collect, scalable, applicable across the spectrum, useful across wide age ranges, rapidly and repeatedly collected, and require minimal training. Gaze-based indices, if validated, satisfy these characteristics and, given the fact that they are already being transformed into scalable and easy-to-use systems, have great potential for rapid adoption in the next few years.