Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children
Public ClinicalTrials.gov record NCT05675371. 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, Longitudinal Study of Dynamic Quantification of Social-Visual Engagement (DQSVE) For Treatment Monitoring In Children With Autism Spectrum Disorder (ASD).
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 monitor changes in a child's verbal ability, non-verbal learning, and social disability over time in children ages 15-84 months with autism spectrum disorder or related developmental delays (DD) and in those who are typically developing. The main questions it aims to answer are: * To estimate the change in each of the EarliPoint index scores in typically developing children ages 15-84 months from baseline through 180 days as a function of the child's age. * To estimate the change in the EarliPoint verbal and non-verbal index scores in ASD/DD children ages 15-84 months from baseline through 180 days as a function of the child's age in: a) those who showed clinical improvement, and b) those who did not show clinical improvement. * To estimate the relationship of the EarliPoint verbal and non-verbal index scores to clinical reference assessments in ASD/DD children as a function of their age from baseline through 180 days. * To estimate the degree of change, if change occurs, month-to-month in the EarliPoint Social Disability Index score from baseline through 180 days. * To estimate the incidence of behavioral events (e.g., tantrums, etc.) which limit the subject from completing an eye-tracking session. * To estimate the incidence of adverse device effects associated with the use of the study device.
Study identification
- NCT ID
- NCT05675371
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 325 participants
Conditions and interventions
Conditions
Interventions
- Assessment by Expert Clinician During Behavioral Intervention (ABA or similar) Behavioral
- Assessment by the EarliPoint Assessment For Autism Spectrum Disorder Device
Behavioral · Device
Eligibility (public fields only)
- Age range
- 15 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
- Mar 31, 2023 (Actual)
- Primary completion
- Sep 8, 2025 (Actual)
- Completion
- Sep 8, 2025 (Actual)
- Last update posted
- Sep 15, 2025
2023 – 2025
United States locations
- U.S. sites
- 9
- U.S. states
- 6
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southwest Autism Research and Resource Center (SARRC) | Phoenix | Arizona | 85006 | — |
| Cortica - Glendale | Glendale | California | 91203 | — |
| Cortica - Marin | San Rafael | California | 94903 | — |
| Cortica - Torrance | Torrance | California | 90503 | — |
| Cortica - Weslake Village | Westlake Village | California | 91361 | — |
| Emory University/Marcus Autism Center | Atlanta | Georgia | 30329 | — |
| Munroe-Meyer Institute / University of Nebraska | Omaha | Nebraska | 68106 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| AJ Drexel Autism Institute, Drexel University | Philadelphia | Pennsylvania | 19104 | — |
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 NCT05675371, 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 15, 2025 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05675371 live on ClinicalTrials.gov.