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.
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 - 96 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.
Study Type
OBSERVATIONAL
Enrollment
929
Diagnosis by the EarliPoint System: Evaluation for Autism Spectrum Disorder
Diagnosis by an expert clinician using gold standard developmental assessment tools.
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
EarliPoint sensitivity
The sensitivity of the EarliPoint device relative to the Clinically Certain-Expert Clinician Diagnosis (CC-ECD), defined as the proportion of clinically positive subjects for whom both the EarliPoint and CC-ECD diagnoses are positive.
Time frame: at baseline
EarliPoint specificity
The specificity of the EarliPoint device relative to the CC-ECD, defined as the proportion of clinically negative subjects for whom the EarliPoint and CC-ECD procedure are negative.
Time frame: at baseline
EarliPoint Social Disability Index Score
The Correlation between the EarliPoint Social Disability Index score and the Autism Diagnostic Observation Schedule, second edition (ADOS-2) Overall Total Score.
Time frame: at baseline
EarliPoint Verbal Ability Index score
The correlation between the EarliPoint Verbal Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (Verbal Ability Cluster).
Time frame: at baseline
EarliPoint Receptive Language Ability Index Score
The correlation between the EarliPoint Receptive Language Ability Index Score and the Differential Ability Scales (Verbal Comprehension Sub-scale).
Time frame: at baseline
EarliPoint Expressive Language Ability Index score
The correlation between the EarliPoint Expressive Language Ability Index score and the clinical measures of expressive language ability as measured by the Differential Ability Scales (Naming Vocabulary Subscale).
Time frame: at baseline
EarliPoint Nonverbal Ability Index score
The correlation between the EarliPoint Nonverbal Ability Index score and the clinical measures of nonverbal abilities as measured by the Differential Abilities Scales (nonverbal ability cluster).
Time frame: at baseline
Adverse Device Effects
The occurrence of adverse device effects associated with the use of the EarliPoint device.
Time frame: at baseline
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