Validation of Indiana's Early Evaluation Hub System

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.

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.

Sponsors & Collaborators

• Purdue University

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Indiana University

  lead OTHER

Principal Investigators

• Rebecca McNally-Keehn, PhD, HSPP · IU School of Medicine

• Brandon Keehn, PhD · Purdue University

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

14 Months

Max Age

48 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-07

Primary Completion

2022-09-23

Completion

2022-09-23

FDA Device

Yes

Countries

• United States

Study Locations