Dynamic Quantification of Social-Visual Engagement in Autism Spectrum Disorder (ASD) For Children Ages 31-84 Months — MEASURE-ASD2  

Autism Spectrum Disorder Clinical Trial

Official title: A Prospective, Multi-Center Study of Dynamic Quantification of Social-Visual Engagement (DQSVE) in Autism Spectrum Disorder (ASD): Diagnosis and Assessment For Children Ages 31 - 84 Months

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 diagnose and assess autism spectrum disorder (ASD) in children ages 31-84 month (2.5 - 7 years chronological age).

The main questions it aims to answer are:

1. To determine the sensitivity and specificity of the EarliPoint device (test) compared to Expert Clinician Diagnosis (ECD) using gold-standard clinical reference assessments in the target age-expanded population.

2. To determine the association between the EarliPoint Verbal Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (DAS-II).

3. To determine the association between the EarliPoint Nonverbal Ability Index score and the clinical measures of non-verbal abilities as measured by the Differential Ability Scales (DAS-II).

4. To determine the association between the EarliPoint Social Disability Index score and the Autism Diagnostic Observation Schedule, second edition (ADOS-II) Overall Total Score.

5. To determine the association between the EarliPoint Expressive Language Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (DAS-II).

6. To determine the association between the EarliPoint Receptive Language Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (DAS-II).

7. To estimate the incidence of adverse device effects associated with the use of the EarliPoint device.

Clinical Trial Description

This is a prospective, multi-center, double-blind, within-subject comparison study of Dynamic Quantification of Social-Visual Engagement (DQSVE) for diagnosis of ASD and/or related developmental delays (DD) in children ages 31 - 84 months (2.5 - 7 years chronological age). The study will enroll children suspected to have ASD (ASD-positive) and those who do not have ASD (ASD-negative). Eligible participants who sign the Informed Consent Form will be consecutively screened at each study site and enrolled in the appropriate subject group (either suspected ASD/DD or non-ASD).

The main questions it aims to answer are:

1. To determine the sensitivity and specificity of the EarliPoint device (test) compared to Expert Clinician Diagnosis (ECD) using gold-standard clinical reference assessments in the target age-expanded population.

2. To determine the association between the EarliPoint Verbal Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (DAS-II).

3. To determine the association between the EarliPoint Nonverbal Ability Index score and the clinical measures of non-verbal abilities as measured by the Differential Ability Scales (DAS-II).

4. To determine the association between the EarliPoint Social Disability Index score and the Autism Diagnostic Observation Schedule, second edition (ADOS-II) Overall Total Score.

5. To determine the association between the EarliPoint Expressive Language Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (DAS-II).

6. To determine the association between the EarliPoint Receptive Language Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (DAS-II).

7. To estimate the incidence of adverse device effects associated with the use of the EarliPoint device. ;

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

• NCT number: NCT05806216
• Study type: Observational
• Source: EarliTec Diagnostics, Inc
• Contact: CLN-1005-02 Study Manager
• Phone: 833-504-9937
• Email: clinicalaffairs@earlitecdx.com
• Status: Recruiting
• Start date: August 23, 2023
• Completion date: March 28, 2025