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.
Age range
31 Months – 84 Months
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
EarliPoint sensitivity
Timeframe: at baseline
EarliPoint specificity
Timeframe: at baseline