Schweitzer Engineering Laboratories
Autism spectrum disorder (ASD) is a developmental condition that can affect communication, social interaction, and behavior. Identifying ASD early helps children and families access support services sooner. Pupillometry is a way of measuring the nervous system and brain function by recording the pupil response to light. It is a non-invasive technology that may support screening practices by providing health care providers with an objective physical measure to bolster behavioral screening tools used to identify children with ASD . This study is evaluating how well the APS Detect™ handheld pupillometer works to help screen for ASD in children 2 to 4 years of age during routine pediatric healthcare visits. This investigational device measures the child's pupil response to light and uses these measurements to estimate the likelihood of ASD. Researchers will compare screening results using the APS Detect with the results of reference standard clinical assessments used to determine whether a child has autism. The study will assess how accurately the device identifies children with autism compared to children with typical development based on the Autism Pupil Screen (APS) score. The study will also evaluate whether the device provides the same results when used by different healthcare professionals. Information collected during this study will be used to evaluate device performance, safety, and suitability for use in pediatric healthcare settings and may support future review by the U.S. Food and Drug Administration (FDA).
This prospective, multicenter clinical study will test the safety and effectiveness of the APS Detect™ hand-held pupillometer for screening autism spectrum disorder (ASD) in children 2 to 4 years of age during routine pediatric healthcare visits. Participants will undergo APS Detect pupillary light reflect (PLR) testing and standardized clinical evaluations used to determine ASD diagnostic outcomes. Device performance will be evaluated by comparing scores for each participant obtained from the device to the diagnostic outcomes determined through reference standard clinical assessments used to…
Inclusion Criteria: Children between 24 months and 60 months of age Exclusion Criteria: Children with a prior diagnosis of ASD Children experiencing a seizure within the past 6 months prior to the first day of testing Children that have experienced head trauma Children that have hearing loss or vision loss corrected or uncorrected that impacts their daily life Children that had any known exposure to alcohol, drugs, prescription medications, or environmental toxins before or after birth
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.
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.
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.
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.
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.
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.
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.
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.
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.