Speaker

Warren Jones, PhD
Director of Research, Marcus Autism Center
Children’s Healthcare of Atlanta
Norman Nien Distinguished Chair in Autism
Associate Professor, Dept. of Pediatrics
Emory University School of Medicine

Slides

Keywords

Autism Spectrum Disorder, Biomarkers, Social Visual Engagement

Key Points

• Autism affects 1 in every 36, impacting more than 9.1 million individuals and their families in the U.S. When we think about conditions that affect young children and their families, autism is one of the most common.

• Parents in the U.S. spend an average of 2-3 years between the time when they first begin to worry and the time when they finally receive a diagnosis. There are not enough expert clinicians or expert centers to meet public need. Disadvantaged families wait even longer.

• Clinicians need more measures that are objective, quantitative, dimensional and fine-grained, performance-based, standardized, efficient and community-viable, able to capture core features of social disability, and mechanistically relevant.

• Social visual engagement measures how children look at and learn from their surrounding social environment. Children look at and acquire information from what they are looking at. Researchers use eye tracking data to measure social visual engagement, which reflects early-emerging differences in autism spectrum disorder (ASD).

• In 3 studies, researchers tested the performance of eye-tracking-based assays of social visual engagement in 16-30-month-old children to accurately assess presence of ASD and accurately assess severity of ASD.

• The Discovery study included 719 participants, and the Replication study included 370 participants aged 16-30 months old. The initial Discovery study and first Replication study showed high sensitivity and specificity when comparing eye-tracking-based measures of social visual engagement with expert clinician diagnosis in children approximately 16-30 months old.

• With the results from the initial studies, the trial team embarked on a multi-site clinical trial at 6 sites across the U.S. 475 participants completed eye-tracking measurement of social visual engagement, expert clinical diagnosis, and a rating of expert diagnostic certainty.

• The study resulted in 335 participants with a reference standard certain diagnosis for ASD and 140 with a reference standard uncertain diagnosis for ASD. The children seen in the study who did not have autism did have other developmental diagnoses, which highlights the challenge of diagnosing children with developmental delays.

• Study results show a high sensitivity and specificity when comparing eye-tracking-based measures of social visual engagement with expert clinician diagnosis in children as young as 16-30 months old. Results also show a strong correlation with standardized assessments given by experienced clinicians

Learn More

Read more in JAMA.

Discussion Themes

-Is there an eventual hope that a tool like this could be used without a referral to a specialty center? Absolutely. We started at a point to try to develop a tool with gold standard outcomes, and we are going on to test screening studies in other age groups. Our hope is to extend and develop clinical tools that could be easier to use.

–What did you learn that informed the development of tools that would be more generalizable? This work has been conducted in conversation with FDA for many years, successfully moving something that was lab-based to increasingly more real-world. We are working toward making this more usable by general clinicians, asking what they need and want to make it more useful. For the screening studies, we looked at the SMART study framework for clinical trials to get to who is most likely to need a diagnostic evaluation.

Tags

#pctGR, @Collaboratory1