Dynamic Quantification of Social-Visual Engagement in Autism Spectrum Disorder (ASD)
Public ClinicalTrials.gov record NCT05806216. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05806216
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 929 participants
Conditions and interventions
Conditions
Interventions
- EarliPoint Diagnosis Device
- Clinically Certain Expert Clinician Diagnosis (CC-ECD) Behavioral
Device · Behavioral
Eligibility (public fields only)
- Age range
- 31 Months to 84 Months
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 22, 2023
- Primary completion
- Mar 26, 2025
- Completion
- Aug 30, 2025
- Last update posted
- Sep 14, 2025
2023 – 2025
United States locations
- U.S. sites
- 9
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southwest Autism Research and Resource Center | Phoenix | Arizona | 85006 | — |
| Emory University - Marcus Autism Center | Altanta | Georgia | 30329 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01655 | — |
| ThompsonCenter for Autism & Neurodevelopment; University of Missouri | Columbia | Missouri | 65211 | — |
| Monroe-Meyer Institute for Genetics and Rehabilitation / University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Seattle Children's Hospital | Seattle | Washington | 98115 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05806216, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 14, 2025 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05806216 live on ClinicalTrials.gov.