A Multi-site Comparison of Social Visual Engagement to Clinical Diagnosis for Autism Spectrum Disorder

CompletedOBSERVATIONAL
Enrollment

505

Participants

Timeline

Start Date

April 7, 2018

Primary Completion Date

May 31, 2019

Study Completion Date

May 31, 2019

Conditions
Autism Spectrum Disorder
Interventions
DEVICE

Marcus Autism Center Investigational Device

This trial will ascertain whether the binary results of autism or not-autism as determined by the Marcus Autism Center Investigational Device match expert clinical diagnostic opinion. The investigational device is designed to measure visual attention to social information in the environment relative to normative, age-specific benchmarks; these measurements assess presence (primary efficacy outcome) and severity (secondary outcomes) of autism spectrum disorder in 16- to 30-month-old children.

Trial Locations (6)

30329

Emory University, Atlanta

45229

Cincinnati Children's Hospital, Cincinnati

60612

Rush University Medical Center, Chicago

85006

Southwest Autism Research and Resource Center, Phoenix

94143

University of California San Francisco, San Francisco

98105

Seattle Children's Hospital, Seattle

Sponsors
All Listed Sponsors
lead

EarliTec Diagnostics, Inc

INDUSTRY