Treatment Monitoring in Autism Spectrum Disorder (ASD) in Toddlers

The goal of this clinical study is to learn about the utility and performance of the EarliPoint(™) Evaluation for Autism Spectrum Disorder to monitor changes in a child's verbal ability, non-verbal ability, and social disability over time in children ages 16-30 months with autism spectrum disorder and in those who are neurotypical.The main questions it aims to answer are:To estimate the change in each of the EarliPoint index scores in neurotypical children ages 16-30 months from baseline through 180 days as a function of the child's age.To estimate the change in each of the EarliPoint index scores in ASD/DD children ages 16-30 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 index scores to clinical reference assessments in ASD/DD children as a function of their age 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.

Inclusion Criteria:Subjects must meet all the following inclusion criteria to participate in this study.Male or female individuals between the ages of 16-26 months (chronological age) at the time of consent who have autism spectrum disorder and/or related developmental delays or those who are neurotypically developing.Normal or corrected-to-normal vision with visual acuity and oculomotor function sufficient to watch short videos.Hearing adequate to hear information presented in age-appropriate videos of social interactions.For individuals who have autism spectrum disorder and/or related developmental delays, the subject must be established in treatment (e.g., a treatment plan has been developed and child is undergoing treatment or will immediately begin treatment) and intends to remain in treatment continuously throughout the duration of the study.For individuals who are neurotypically developing, the parent, referring clinician and/or daycare center have indicated that the child is not suspected of, nor has he/she exhibited signs of, developmental delays. NOTE: If, at screening, the investigator suspects the TD subject of having a developmental delay (based on the results of the ASQ parent questionnaire and feedback from referring clinician and/or daycare center), the subject shall be screen failed. He/she should be referred for diagnosis and then may be re-screened for the study.Subject and parent (or legally authorized representative) are able and agree to attend each required study visit and complete the full battery of psychometric assessments and questionnaires (electronically or in-person where required).Subject's parent (or legally authorized representative) can understand information, instructions, and videos presented in the English language.Subject's parent (or legally authorized representative) can read and understand the Informed Consent Form (ICF).Subject's parent (or legally authorized representative) provides written informed consent allowing the child subject to participate in the study. NOTE: where able, the child subject should also provide assent.Exclusion Criteria:Subjects who meet any of the following exclusion criteria are not eligible to participate in this study:Severe hearing or visual impairment (e.g., congenital nystagmus, congenital cataracts, previous diagnosis of severe hearing deficits by otoacoustic emissions or auditory brainstem response), which in the opinion of the investigator, would limit the child from completing the EarliPoint eye-tracking procedure or clinical reference assessments. Corrective lenses are allowable up to a prescription of +/- 5.0.Subject has an uncontrolled seizure disorder.Subject is unable or unwilling to undergo DQSVE testing for up to 20 minutes per assessment (e.g., child has frequent tantrums and tantrums do not subside within 5 minutes).In the opinion of the investigator, the subject and/or parent (or legally authorized representative) are unable, unwilling, or unlikely to comply with all study required procedures and follow-up assessments or to complete the full battery of psychometric assessments (electronically or in-person where required).Subject is receiving or plans to receive any investigational drug or device for the duration of this study.In the opinion of the Investigator, subject is not a suitable candidate for participation in a research study (NOTE: reason must be specified).Typically developing children who have 1st degree relative (biological parent or biological sibling) with a diagnosis of autism and/or related developmental delay.