Validation of Indiana's Early Evaluation Hub System

NACompletedINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

June 7, 2019

Primary Completion Date

September 23, 2022

Study Completion Date

September 23, 2022

Conditions
Autism
Interventions
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.

Trial Locations (7)

46011

Community Health Network, Anderson

46202

Riley Hospital for Children, Indianapolis

46580

Lutheran Health Physicians Pediatric Healthcare, Warsaw

46617

Primary Care Partners of South Bend, South Bend

47006

Margaret Mary Health Pediatrics, Batesville

47304

Meridian Health Pediatrics, Muncie

47630

Deaconess Riley Children's Specialty Center, Newburgh

All Listed Sponsors
collaborator

Purdue University

OTHER

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Indiana University

OTHER

NCT06586788 - Validation of Indiana's Early Evaluation Hub System | Biotech Hunter | Biotech Hunter