NCT06586788

Validation of Indiana's Early Evaluation Hub System

Validation of Indiana's Early Neurodevelopmental Evaluation Hub Program

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 14 Months – 48 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Autism

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Eyelink Portable Duo	Eye-tracking data will be collected using a commercially-available remote eye-tracking system (Eyelink Portable Duo). Eye movements and pupil diameter will be collected while participants view a series of developmentally appropriate pictures and movies. The eye-tracker consists of two cameras; one that monitors eye movements and a second scene camera that monitors head movements, which permits eye tracking to take place without any equipment touching the child. Children will be asked to sit in highchair or on a caregiver's lap and will face a computer monitor. After a sticker is applied to the child's forehead and brief eye-movement calibration completed, next visual stimuli (i.e., pictures and videos) will be presented on a laptop computer monitor that is placed at approximately 60-80cm from the child. The eye tracking portion of the visit will last approximately 15 minutes or until the child is no longer able to attend to pictures/videos.
DIAGNOSTIC_TEST	Integrated PCP Diagnosis and Eye-tracking Biomarker	A Classification and Regression Tree (CART) Analysis, based on recursive partitioning, was 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.

Timeline

• Start date: 2019-06-07
• Primary completion: 2022-09-23
• Completion: 2022-09-23
• First posted: 2024-09-19
• Last updated: 2024-10-31
• Results posted: 2024-10-31

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study