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Dynamic Quantification of Social-Visual Engagement in Autism Spectrum Disorder (ASD)

NCT05806216 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 929

Last updated 2025-09-15

No results posted yet for this study

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 31-96 months (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.

Conditions

Interventions

DEVICE

EarliPoint Diagnosis

Diagnosis by the EarliPoint System: Evaluation for Autism Spectrum Disorder

BEHAVIORAL

Clinically Certain Expert Clinician Diagnosis (CC-ECD)

Diagnosis by an expert clinician using gold standard developmental assessment tools.

Sponsors & Collaborators

  • EarliTec Diagnostics, Inc

    lead INDUSTRY

Principal Investigators

  • John Reviere · EarliTec Diagnostics, Inc

Eligibility

Min Age
31 Months
Max Age
84 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-23
Primary Completion
2025-03-27
Completion
2025-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05806216 on ClinicalTrials.gov