Skip to main content
OpenTrials
Completed

NCT Number: NCT06586788

Validation of Indiana's Early Evaluation Hub System

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Disease Mental Disorders Neurodevelopmental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

14 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Health Network, Anderson, Indiana, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eyelink Portable Duo

Diagnostic Test

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.

Integrated PCP Diagnosis and Eye-tracking Biomarker

Diagnostic Test

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Purdue University

Registry information

Official study title

Validation of Indiana's Early Neurodevelopmental Evaluation Hub Program

Acronym: EAER21

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.