Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children
Completed
Conditions studied: Autism Spectrum Disorder, Autism, Developmental Delay, Autism, Early Infantile, Autism, Infantile
In brief
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.
Key facts
- Study ID
- NCT05675371
- Run by
- EarliTec Diagnostics, Inc
- People needed
- 325
- Starts
- 2023-03-31
- Expected to finish
- 2025-09-08
- Last updated by the study team
- 2025-09-15
Who can join
Age: 1 and older, up to 7. Sex: any. Healthy volunteers: accepted.
Where it is running
- Southwest Autism Research and Resource Center (SARRC) — Phoenix, Arizona, United States
- Cortica - Glendale — Glendale, California, United States
- Cortica - Marin — San Rafael, California, United States
- Cortica - Torrance — Torrance, California, United States
- Cortica - Weslake Village — Westlake Village, California, United States
- Emory University/Marcus Autism Center — Atlanta, Georgia, United States
- Munroe-Meyer Institute / University of Nebraska — Omaha, Nebraska, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- AJ Drexel Autism Institute, Drexel University — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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