NCT05675371

Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children

A Prospective, Multi-Center, Longitudinal Study of Dynamic Quantification of Social-Visual Engagement (DQSVE) For Treatment Monitoring In Children With Autism Spectrum Disorder (ASD).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 325 (actual)
• Sponsor: EarliTec Diagnostics, Inc · Industry
• Sex: All
• Age: 15 Months – 84 Months
• Healthy volunteers: Accepted

Summary

The goal of this clinical study is to learn about the utility and performance of the EarliPoint(™) System: Evaluation for Autism Spectrum Disorder to monitor changes in a child's verbal ability, non-verbal learning, and social disability over time in children ages 15-84 months with autism spectrum disorder or related developmental delays (DD) and in those who are typically developing. The main questions it aims to answer are: * To estimate the change in each of the EarliPoint index scores in typically developing children ages 15-84 months from baseline through 180 days as a function of the child's age. * To estimate the change in the EarliPoint verbal and non-verbal index scores in ASD/DD children ages 15-84 months from baseline through 180 days as a function of the child's age in: a) those who showed clinical improvement, and b) those who did not show clinical improvement. * To estimate the relationship of the EarliPoint verbal and non-verbal index scores to clinical reference assessments in ASD/DD children as a function of their age from baseline through 180 days. * To estimate the degree of change, if change occurs, month-to-month in the EarliPoint Social Disability Index score from baseline through 180 days. * To estimate the incidence of behavioral events (e.g., tantrums, etc.) which limit the subject from completing an eye-tracking session. * To estimate the incidence of adverse device effects associated with the use of the study device.

Detailed description

This study seeks to evaluate the utility and performance of the EarliPoint(™) System: Evaluation for Autism Spectrum Disorder in monitoring changes in a child's verbal ability, non-verbal learning, and social disability over time in children ages 15-84 months with autism spectrum disorder and in those who are typically developing. The main questions it aims to answer are: * To estimate the change in each of the EarliPoint index scores in typically developing children ages 15-84 months from baseline through 180 days as a function of the child's age. * To estimate the change in the EarliPoint verbal and non-verbal index scores in ASD/DD children ages 15-84 months from baseline through 180 days as a function of the child's age in: a) those who showed clinical improvement, and b) those who did not show clinical improvement. * To estimate the relationship of the EarliPoint verbal and non-verbal index scores to clinical reference assessments in ASD/DD children as a function of their age from baseline through 180 days. * To estimate the degree of change, if change occurs, month-to-month in the EarliPoint Social Disability Index score from baseline through 180 days. * To estimate the incidence of behavioral events (e.g., tantrums, etc.) which limit the subject from completing an eye-tracking session. * To estimate the incidence of adverse device effects associated with the use of the study device.

Conditions

• Autism Spectrum Disorder
• Autism
• Developmental Delay
• Autism, Early Infantile
• Autism, Infantile

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-31
• Primary completion: 2025-09-08
• Completion: 2025-09-08
• First posted: 2023-01-09
• Last updated: 2025-09-15

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study