Dynamic Quantification of Social-Visual Engagement in Autism Spectrum Disorder (ASD)
Completed
Conditions studied: Autism Spectrum Disorder, Autism
In brief
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.
Key facts
- Study ID
- NCT05806216
- Run by
- EarliTec Diagnostics, Inc
- People needed
- 929
- Starts
- 2023-08-23
- Expected to finish
- 2025-08-31
- Last updated by the study team
- 2025-09-15
Who can join
Age: 3 and older, up to 7. Sex: any. Healthy volunteers: accepted.
Where it is running
- Southwest Autism Research and Resource Center — Phoenix, Arizona, United States
- Emory University - Marcus Autism Center — Altanta, Georgia, United States
- University of Iowa — Iowa City, Iowa, United States
- University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States
- ThompsonCenter for Autism & Neurodevelopment; University of Missouri — Columbia, Missouri, United States
- Monroe-Meyer Institute for Genetics and Rehabilitation / University of Nebraska Medical Center — Omaha, Nebraska, United States
- Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- Seattle Children's Hospital — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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