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2a - Model Development for Autism Spectrum Disorder (MEASURE-ASD2 Trial)
MEASURE-ASD2 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: 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. 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). 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). To determine the association between the EarliPoint Social Disability Index score and the Autism Diagnostic Observation Schedule, second edition (ADOS-II) Overall Total Score. 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). 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). To estimate the incidence of adverse device effects associated with the use of the EarliPoint device.
- Autism Spectrum Disorder
- Autism
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Outcome measures can provide a clearer picture of what you can expect from a treatment.MEASURE-ASD2 Trial Design
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