Arms
Arm A - Autism Spectrum Disorder (ASD)
Participants with Autism Spectrum Disorder (ASD) within Arm A
Arm A - Typical Development (TD) - Not ASD
Participants without Autism Spectrum Disorder (ASD) within Arm A
Arm B - Autism Spectrum Disorder (ASD)
Participants with Autism Spectrum Disorder (ASD) within Arm B Precision Sub-study
Arm B - Typical Development (TD) - Not ASD
Participants without Autism Spectrum Disorder (ASD) within Arm B Precision Sub-study
Interventions
Autism Pupil Screen (APS) Detect PLR Assessment #1
The APS Detect™ is an investigational handheld pupillometer that measures pupillary light reflex (PLR) responses using a brief, noninvasive assessment. Measurements obtained by the device are used to generate an Autism Pupil Screening (APS) score that is intended to help identify children who may be at risk for autism spectrum disorder (ASD) during routine pediatric healthcare visits. The APS Detect is investigational and has not been cleared by the U.S. Food and Drug Administration (FDA) for clinical use.
Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT/R-F)
A validated parent- or caregiver-completed screening tool used to identify children who may be at risk for autism spectrum disorder (ASD). The questionnaire is designed for children between 16 and 30 months of age and consists of an initial screening questionnaire followed by a structured follow-up interview for children with positive screening results. The M-CHAT-R/F is intended to identify children who may benefit from further developmental and diagnostic evaluation for ASD.
Social Responsiveness Scale, Second Edition (SRS-2)
A standardized questionnaire used to measure the presence and severity of social communication difficulties and restricted or repetitive behaviors associated with autism spectrum disorder (ASD). The SRS-2 is completed by a parent, caregiver, teacher, or other knowledgeable respondent and provides quantitative scores that help assess social functioning and identify characteristics associated with ASD across a range of ages. It is intended to support the screening and evaluation of individuals who may have ASD and to monitor changes in social responsiveness over time.
Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
A standardized, play-based assessment administered by a trained clinician to evaluate social communication, social interaction, play, and restricted or repetitive behaviors associated with autism spectrum disorder (ASD). The ADOS-2 consists of age- and language-specific assessment modules and is widely used as part of a comprehensive diagnostic evaluation to support the identification and classification of ASD.
Mullen Scales of Early Learning (MSEL)
A standardized developmental assessment administered by a trained examiner to evaluate cognitive and developmental functioning in young children from birth through 68 months of age. The assessment measures visual reception, fine motor skills, receptive language, and expressive language and provides information about a child's developmental abilities relative to age-based expectations.
Adaptive Behavior Assessment System, Third Edition (ABAS-3)
A standardized assessment completed by a parent, caregiver, teacher, or other knowledgeable respondent to evaluate adaptive functioning in everyday life. The ABAS-3 measures skills across conceptual, social, and practical domains, including communication, self-care, social interaction, community use, and functional academics. Results provide an assessment of an individual's ability to perform age-appropriate daily activities and support the evaluation of developmental, intellectual, and behavioral functioning.
Autism Pupil Screen (APS) Detect PLR Assessment #2
The APS Detect™ is an investigational handheld pupillometer that measures pupillary light reflex (PLR) responses using a brief, noninvasive assessment. Measurements obtained by the device are used to generate an Autism Pupil Screening (APS) score that is intended to help identify children who may be at risk for autism spectrum disorder (ASD) during routine pediatric healthcare visits. The APS Detect is investigational and has not been cleared or approved by the U.S. Food and Drug Administration (FDA) for clinical use.
This intervention will be used for the second assessment with the APS Detect™ in Arm B, the precision sub-study to evaluate the reliability and reproducibility of the Autism Pupil Screening (APS) Detect™ investigational device.
Autism Pupil Screen (APS) Detect Assessment #3
The APS Detect™ is an investigational handheld pupillometer that measures pupillary light reflex (PLR) responses using a brief, noninvasive assessment. Measurements obtained by the device are used to generate an Autism Pupil Screening (APS) score that is intended to help identify children who may be at risk for autism spectrum disorder (ASD) during routine pediatric healthcare visits. The APS Detect is investigational and has not been cleared or approved by the U.S. Food and Drug Administration (FDA) for clinical use.
This intervention will be used for the third assessment with the APS Detect™ in Arm B, the precision sub-study to evaluate the reliability and reproducibility of the Autism Pupil Screening (APS) Detect™ investigational device.
Well-child check
A routine pediatric healthcare visit that includes assessment of growth, development, general health, and age-appropriate preventive care. The visit may include a physical examination, developmental surveillance, review of medical history, and discussion of health concerns with the child's parent or caregiver following the American Academy of Pediatrics (AAP) Bright Futures guidelines.