Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05806216
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2023-03-16
Brief Title:
Dynamic Quantification of Social-Visual Engagement in Autism Spectrum Disorder ASD For Children Ages 31-84 Months
Sponsor:
EarliTec Diagnostics Inc
Organization:
EarliTec Diagnostics Inc
Study Overview
Official Title:
A Prospective Multi-Center Study of Dynamic Quantification of Social-Visual Engagement DQSVE in Autism Spectrum Disorder ASD Diagnosis and Assessment For Children Ages 31 - 84 Months
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEASURE-ASD2
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 31-84 month 25 - 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
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
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 andor related developmental delays DD in children ages 31 - 84 months 25 - 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 ASDDD 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None