A Prospective, Multi-Center Study of Dynamic Quantification of Social-Visual Engagement (DQSVE) in Autism Spectrum Disorder (ASD): Diagnosis and Assessment For Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- EarliTec Diagnostics, Inc
- Enrollment
- 929
- Locations
- 9
- Primary Endpoint
- EarliPoint sensitivity
Study Overview
Brief 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:
- 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.
Detailed Description
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:
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 31 Months to 84 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
EarliPoint sensitivity
Time Frame: at baseline
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.
EarliPoint specificity
Time Frame: at baseline
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.
Secondary Outcomes
- EarliPoint Verbal Ability Index score(at baseline)
- Adverse Device Effects(at baseline)
- EarliPoint Social Disability Index Score(at baseline)
- EarliPoint Receptive Language Ability Index Score(at baseline)
- EarliPoint Expressive Language Ability Index score(at baseline)
- EarliPoint Nonverbal Ability Index score(at baseline)