Validation of Indiana's Early Neurodevelopmental Evaluation Hub Program
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Autism
- Sponsor
- Indiana University
- Enrollment
- 154
- Locations
- 7
- Primary Endpoint
- Agreement Between Composite Eye-tracking Biomarker and Expert Autism-specialist
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The investigators' objective is to test an innovative method of autism diagnosis that integrates clinical evaluation and assessment of biobehavioral markers in a large high-risk community-referral sample of children in the primary care setting.
Detailed Description
Determine whether eye-tracking biomarkers can reliably differentiate young children with and without autism in a community referred sample. The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism in young children. Differences in metrics between children with and without autism will be compared to validate potential eye-tracking biomarkers. Determine whether a combination of clinical (i.e., EE Hub PCP measures) and eye-tracking biomarkers can be used to accurately predict autism diagnostic outcome in a sample of young children evaluated for autism in the primary care setting.
Investigators
Rebecca McNally Keehn
Assistant Professor of Pediatrics
Indiana University
Eligibility Criteria
Inclusion Criteria
- •Young children ages 14-48 months seen at an EE hub and referred for a comprehensive autism evaluation.
- •Children must have English-speaking caregivers. Children must have a legal guardian that is able to provide consent.
Exclusion Criteria
- •Child is younger than 14 months or older than 48 months. Child's caregiver(s) is/are not English-speaking.
Outcomes
Primary Outcomes
Agreement Between Composite Eye-tracking Biomarker and Expert Autism-specialist
Time Frame: Day 1
Sensitivity and specificity of a composite eye-tracking (i.e., index) test, which was a consolidated measure based on significant eye-tracking indices, compared to reference standard expert clinical autism diagnosis.
Agreement Between Integrated PCP, Eye-tracking Biomarker Score and Expert Autism-specialist
Time Frame: Day 1
Classification and Regression Tree (CART) analysis, based on recursive partitioning, is used to determine which combination of variables (EE Hub PCP diagnosis, diagnostic certainty, composite biomarker, and biomarker frequency \[sum of all individual biomarkers (0-6) that exceeded the 95% specificity threshold for each child\]) best predicted reference standard autism diagnosis.