Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children

Active, not recruiting

• Conditions: Autism Spectrum Disorder; Autism; Developmental Delay; Autism, Early Infantile; Autism, Infantile

• Registration Number: NCT05675371
• Lead Sponsor: EarliTec Diagnostics, Inc

Brief 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.

Study Timeline

• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2023-01-06
• Study First Posted: 2023-01-09
• Study Start: 2023-03-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in EarliPoint Index Scores in typically developing children	180 days	To estimate the change in each of the EarliPoint index scores in typically developing children ages 16-30 months form baseline through 180 days as a function of the child's age.
Change in EarliPoint Index Scores in ASD/DD children	180 days	To estimate the change in the EarliPoint verbal and nonverbal index scores in ASD/DD children ages 16-30 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.

Secondary Outcome Measures

Name	Time	Method
Incidence of behavioral events which limit completion of an eye-tracking session.	180 days	To estimate the incidence of behavioral events (e.g., tantrums, inability to calibrate device to child, etc.) which limit the subject from completing an eye-tracking session.
Relationship of the EarliPoint index scores to clinical reference assessments	180 days	To estimate the relationship of the EarliPoint verbal and nonverbal index scores to the Mullen Scales of Early Learning scores in ASD/DD children as a function of their age from baseline though 180-days.
Incidence of adverse device effects associated with use of the study device	180 days	To estimate the incidence of adverse device effects associated with the use of the study device.

Trial Locations

Locations (9)

Southwest Autism Research and Resource Center (SARRC); 🇺🇸 Phoenix, Arizona, United States

Cortica - Glendale; 🇺🇸 Glendale, California, United States

Cortica - Marin; 🇺🇸 San Rafael, California, United States

Cortica - Torrance; 🇺🇸 Torrance, California, United States

Cortica - Weslake Village; 🇺🇸 Westlake Village, California, United States

Emory University/Marcus Autism Center; 🇺🇸 Atlanta, Georgia, United States

Munroe-Meyer Institute / University of Nebraska; 🇺🇸 Omaha, Nebraska, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

AJ Drexel Autism Institute, Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States