Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children — MEASURE-ASD1  

Autism Spectrum Disorder Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autism, Early Infantile
• Autism, Infantile
• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Delay

• NCT number: NCT05675371
• Study type: Observational
• Source: EarliTec Diagnostics, Inc
• Contact: CLN-1005 Clinical Study Manager
• Phone: 833-504-9937
• Email: clinicalaffairs@earlitecdx.com
• Status: Recruiting
• Start date: March 31, 2023
• Completion date: September 30, 2024