Dynamic Quantification of Social-Visual Engagement in Autism Spectrum Disorder (ASD)
- Conditions
- Autism Spectrum DisorderAutism
- Interventions
- Device: EarliPoint DiagnosisBehavioral: Clinically Certain Expert Clinician Diagnosis (CC-ECD)
- Registration Number
- NCT05806216
- Lead Sponsor
- EarliTec Diagnostics, Inc
- 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:
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 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 790
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 2a - Model Development Clinically Certain Expert Clinician Diagnosis (CC-ECD) Enrollment for the purposes of training the EarliPoint system data models in children ages 31-84 months suspected of autism spectrum disorder or related developmental delays or those who are typically developing. 2a - Model Development EarliPoint Diagnosis Enrollment for the purposes of training the EarliPoint system data models in children ages 31-84 months suspected of autism spectrum disorder or related developmental delays or those who are typically developing. 2b - Model Testing EarliPoint Diagnosis Enrollment for the purposes of testing/validating the EarliPoint system data models in children ages 31-84 months suspected of autism spectrum disorder or related developmental delays or those who are typically developing. 2b - Model Testing Clinically Certain Expert Clinician Diagnosis (CC-ECD) Enrollment for the purposes of testing/validating the EarliPoint system data models in children ages 31-84 months suspected of autism spectrum disorder or related developmental delays or those who are typically developing.
- Primary Outcome Measures
Name Time Method EarliPoint sensitivity 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 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 Outcome Measures
Name Time Method EarliPoint Verbal Ability Index score at baseline 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).
Adverse Device Effects at baseline The occurrence of adverse device effects associated with the use of the EarliPoint device.
EarliPoint Social Disability Index Score at baseline The Correlation between the EarliPoint Social Disability Index score and the Autism Diagnostic Observation Schedule, second edition (ADOS-2) Overall Total Score.
EarliPoint Receptive Language Ability Index Score at baseline The correlation between the EarliPoint Receptive Language Ability Index Score and the Differential Ability Scales (Verbal Comprehension Sub-scale).
EarliPoint Expressive Language Ability Index score at baseline 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).
EarliPoint Nonverbal Ability Index score at baseline 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).
Trial Locations
- Locations (9)
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