Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children

CompletedOBSERVATIONAL
Enrollment

325

Participants

Timeline

Start Date

March 31, 2023

Primary Completion Date

September 8, 2025

Study Completion Date

September 8, 2025

Conditions
Autism Spectrum DisorderAutismDevelopmental DelayAutism, Early InfantileAutism, Infantile
Interventions
BEHAVIORAL

Assessment by Expert Clinician During Behavioral Intervention (ABA or similar)

Assessment (e.g., responder vs. non-responder status) utilizing gold-standard clinical reference assessments performed by expert clinicians as the subject undergoes Applied Behavioral Analysis (ABA) or similar intervention for autism spectrum disorder and related developmental delays

DEVICE

Assessment by the EarliPoint Assessment For Autism Spectrum Disorder

Assessment by The EarliPoint™ Evaluation for Autism Spectrum Disorder (ASD), a medical device which employs Dynamic Quantification of Social-Visual Engagement (DQSVE) to aid clinicians in the diagnosis, assessment, and treatment monitoring of ASD related developmental delays, is a diagnostic tool which measures an individual's visual preferential attention to social information in the environment relative to normative age-specific benchmarks.

Trial Locations (9)

19104

AJ Drexel Autism Institute, Drexel University, Philadelphia

30329

Emory University/Marcus Autism Center, Atlanta

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

68106

Munroe-Meyer Institute / University of Nebraska, Omaha

85006

Southwest Autism Research and Resource Center (SARRC), Phoenix

90503

Cortica - Torrance, Torrance

91203

Cortica - Glendale, Glendale

91361

Cortica - Weslake Village, Westlake Village

94903

Cortica - Marin, San Rafael

Sponsors
All Listed Sponsors
lead

EarliTec Diagnostics, Inc

INDUSTRY