Autism Spectrum DisorderAPS001NCT07903675
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
An observational study of Autism Spectrum Disorder, run by Schweitzer Engineering Laboratories at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Autism Pupil Screen (APS) Detect PLR Assessment #1, Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT/R-F) and Social Responsiveness Scale, Second Edition (SRS-2)
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 330 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Oct 2026to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children and their parents/legal guardians in Washington and Idaho
Who may be able to join
- Children between 24 months and 60 months of age
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
SEL Health Clinic - Lewiston
Lewiston, Idaho, 83501
Keith Gautreaux, (509)338-3800, keith_gautreaux@selinc.com
Teresa Blackner, BS, RN, (509)338-3800, teresa_blackner@selinc.com
- Recruiting
Palouse Pediatrics
Moscow, Idaho, 83843
Kathryn Hryniewicz, MD, (208)882-2247, kathryn.hryniewicz@pullmanregional.org
Tracy Manderville, RN, (208)882-2247, tracy.manderville@pullmanregional.org
- Recruiting
Palouse Pediatrics
Pullman, Washington, 99163
Kathryn Hryniewicz, MD, (509)332-2605, kathryn.hryniewicz@pullmanregional.org
Tracy Manderville, RN, (509)332-2605, tracy.manderville@pullmanregional.org
- Recruiting
SEL Health Clinic - Pullman
Pullman, Washington, 99163
Keith Gautreaux, MD, (509)338-3800, keith_gautreaux@selinc.com
Teresa Blackner, RN, (509)338-3800, teresa_blackner@selinc.com
About this study
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.
Read more
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).
Read the detailed description
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 diagnose ASD.
The primary objective of the study is to evaluate the diagnostic performance of the APS Detect for identifying children with ASD compared with children with typical development. Performance measures include sensitivity, specificity, positive predictive value, and negative predictive value, relative to the reference standard diagnosis.
An embedded precision sub-study will evaluate the reliability and reproducibility of APS scores obtained using the APS Detect. In this sub-study, a subset of participants will undergo multiple APS assessments performed by different clinicians to assess inter-operator consistency and measurement reproducibility.
Data collected during the study will be used to evaluate the performance of the APS Detect in its intended use environment and population and may support future regulatory submissions to the U.S. Food and Drug Administration (FDA).
- Conditions
- Autism Spectrum Disorder
- Being tested
- Autism Pupil Screen (APS) Detect PLR Assessment #1, Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT/R-F), Social Responsiveness Scale, Second Edition (SRS-2), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), Mullen Scales of Early Learning (MSEL)
- Keywords
- Autism Screening, Pupil Screening Autism, Early Identification, Medical Device, APS Detect
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autism Pupil Screen (APS) Detect PLR Assessment #1Device
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)Other
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)Other
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)Diagnostic test
Also called ADOS-2 - Toddler Module, ADOS-2 - Module 1, ADOS-2 - Module 2, ADOS-2 - Module 3
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)Other
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)Other
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 #2Device
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 #3Device
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 checkProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Autism Spectrum Disorder (ASD) | Participants with Autism Spectrum Disorder (ASD) within Arm A Receives: Device: Autism Pupil Screen (APS) Detect PLR Assessment #1; Other: Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT/R-F); Other: Social Responsiveness Scale, Second Edition (SRS-2); Diagnostic Test: Autism Diagnostic Observation Schedule, Second Edition (ADOS-2); Other: Mullen Scales of Early Learning (MSEL); Other: Adaptive Behavior Assessment System, Third Edition (ABAS-3); Procedure: Well-child check | |
| Arm A - Typical Development (TD) - Not ASD | Participants without Autism Spectrum Disorder (ASD) within Arm A Receives: Device: Autism Pupil Screen (APS) Detect PLR Assessment #1; Other: Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT/R-F); Other: Social Responsiveness Scale, Second Edition (SRS-2); Diagnostic Test: Autism Diagnostic Observation Schedule, Second Edition (ADOS-2); Other: Mullen Scales of Early Learning (MSEL); Other: Adaptive Behavior Assessment System, Third Edition (ABAS-3); Procedure: Well-child check | |
| Arm B - Autism Spectrum Disorder (ASD) | Participants with Autism Spectrum Disorder (ASD) within Arm B Precision Sub-study Receives: Device: Autism Pupil Screen (APS) Detect PLR Assessment #1; Other: Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT/R-F); Other: Social Responsiveness Scale, Second Edition (SRS-2); Diagnostic Test: Autism Diagnostic Observation Schedule, Second Edition (ADOS-2); Other: Mullen Scales of Early Learning (MSEL); Other: Adaptive Behavior Assessment System, Third Edition (ABAS-3); Device: Autism Pupil Screen (APS) Detect PLR Assessment #2; Device: Autism Pupil Screen (APS) Detect Assessment #3; Procedure: Well-child check | |
| Arm B - Typical Development (TD) - Not ASD | Participants without Autism Spectrum Disorder (ASD) within Arm B Precision Sub-study Receives: Device: Autism Pupil Screen (APS) Detect PLR Assessment #1; Other: Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT/R-F); Other: Social Responsiveness Scale, Second Edition (SRS-2); Diagnostic Test: Autism Diagnostic Observation Schedule, Second Edition (ADOS-2); Other: Mullen Scales of Early Learning (MSEL); Other: Adaptive Behavior Assessment System, Third Edition (ABAS-3); Device: Autism Pupil Screen (APS) Detect PLR Assessment #2; Device: Autism Pupil Screen (APS) Detect Assessment #3; Procedure: Well-child check |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of the APS Score to classify ASD diagnostic outcome
This study will test the effectiveness of the APS Detect device results to accurately identify an atypical PLR score for children meeting the criteria for ASD. The study will also test the effectiveness of the APS Detect device results to accurately identify a typical PLR score for children who do not have ASD and have been identified as typically developing.
Measured: From enrollment to the end of all testing visits will be 14-30 days
Secondary outcomes (1)
Positive Predictive Values and Negative Predictive Values
These measures will assess the ability of the APS Detect score to predict the diagnostic outcome taking into consideration the prevalence of ASD, using prevalence rates reported by the Autism and Developmental Disabilities Monitoring Network. This measure will be taken at the end of the study for all child study participants enrolled. This helps determine how likely the device is to detect ASD in routine screening when compared to the general population.
Measured: From enrollment to the end of all testing visits will be 14-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start23 Oct 2026
- Primary completion16 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schweitzer Engineering Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Palouse Pediatrics, Pullman Regional Hospital, Washington State University, SEL Health Clinic
- Responsible party
- Sponsor
- Investigators
- Georgina Lynch, PhD, Principal investigator, Schweitzer Engineering Laboratories, Inc. Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903675
- Sponsor's protocol ID
- 26-0339
- Acronym
- APS001
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified participant data that underlie results in a publication.
Publications
Nystrom P, Gredeback G, Bolte S, Falck-Ytter T; EASE team. Hypersensitive pupillary light reflex in infants at risk for autism. Mol Autism. 2015 Mar 3;6:10. doi: 10.1186/s13229-015-0011-6. eCollection 2015.
PubMed 25750705Guthrie W, Wallis K, Bennett A, Brooks E, Dudley J, Gerdes M, Pandey J, Levy SE, Schultz RT, Miller JS. Accuracy of Autism Screening in a Large Pediatric Network. Pediatrics. 2019 Oct;144(4):e20183963. doi: 10.1542/peds.2018-3963.
PubMed 31562252Lynch GTF, James SM, VanDam M. Pupillary Response and Phenotype in ASD: Latency to Constriction Discriminates ASD from Typically Developing Adolescents. Autism Res. 2018 Feb;11(2):364-375. doi: 10.1002/aur.1888. Epub 2017 Oct 31.
PubMed 29087041Daluwatte C, Miles JH, Sun J, Yao G. Association between pupillary light reflex and sensory behaviors in children with autism spectrum disorders. Res Dev Disabil. 2015 Feb;37:209-15. doi: 10.1016/j.ridd.2014.11.019. Epub 2014 Dec 17.
PubMed 25528080Dinalankara DMR, Miles JH, Nicole Takahashi T, Yao G. Atypical pupillary light reflex in 2-6-year-old children with autism spectrum disorders. Autism Res. 2017 May;10(5):829-838. doi: 10.1002/aur.1745. Epub 2017 Feb 11.
PubMed 28188684Nystrom P, Gliga T, Nilsson Jobs E, Gredeback G, Charman T, Johnson MH, Bolte S, Falck-Ytter T. Enhanced pupillary light reflex in infancy is associated with autism diagnosis in toddlerhood. Nat Commun. 2018 May 7;9(1):1678. doi: 10.1038/s41467-018-03985-4.
PubMed 29735992Lynch G. Using Pupillometry to Assess the Atypical Pupillary Light Reflex and LC-NE System in ASD. Behav Sci (Basel). 2018 Nov 21;8(11):108. doi: 10.3390/bs8110108.
PubMed 30469373
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
- ClinicalTrials.gov ID
- NCT07903675
- Acronym / sponsor ID
- APS001 / 26-0339
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Screening, Pupil Screening Autism, Early Identification, Medical Device, APS Detect
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Schweitzer Engineering LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Palouse Pediatrics, Pullman Regional Hospital, Washington State University, SEL Health Clinic
- Study start
- 23 Oct 2026 (actual)
- Primary completion
- 16 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 diagnose ASD.
The primary objective of the study is to evaluate the diagnostic performance of the APS Detect for identifying children with ASD compared with children with typical development. Performance measures include sensitivity, specificity, positive predictive value, and negative predictive value, relative to the reference standard diagnosis.
An embedded precision sub-study will evaluate the reliability and reproducibility of APS scores obtained using the APS Detect. In this sub-study, a subset of participants will undergo multiple APS assessments performed by different clinicians to assess inter-operator consistency and measurement reproducibility.
Data collected during the study will be used to evaluate the performance of the APS Detect in its intended use environment and population and may support future regulatory submissions to the U.S. Food and Drug Administration (FDA).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A - Autism Spectrum Disorder (ASD) | – | Device: Autism Pupil Screen (APS) Detect PLR Assessment #1, Other: Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT/R-F), Other: Social Responsiveness Scale, Second Edition (SRS-2), Diagnostic Test: Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), Other: Mullen Scales of Early Learning (MSEL), Other: Adaptive Behavior Assessment System, Third Edition (ABAS-3), Procedure: Well-child checkParticipants with Autism Spectrum Disorder (ASD) within Arm A |
| Arm A - Typical Development (TD) - Not ASD | – | Device: Autism Pupil Screen (APS) Detect PLR Assessment #1, Other: Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT/R-F), Other: Social Responsiveness Scale, Second Edition (SRS-2), Diagnostic Test: Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), Other: Mullen Scales of Early Learning (MSEL), Other: Adaptive Behavior Assessment System, Third Edition (ABAS-3), Procedure: Well-child checkParticipants without Autism Spectrum Disorder (ASD) within Arm A |
| Arm B - Autism Spectrum Disorder (ASD) | – | Device: Autism Pupil Screen (APS) Detect PLR Assessment #1, Other: Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT/R-F), Other: Social Responsiveness Scale, Second Edition (SRS-2), Diagnostic Test: Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), Other: Mullen Scales of Early Learning (MSEL), Other: Adaptive Behavior Assessment System, Third Edition (ABAS-3), Device: Autism Pupil Screen (APS) Detect PLR Assessment #2, Device: Autism Pupil Screen (APS) Detect Assessment #3, Procedure: Well-child checkParticipants with Autism Spectrum Disorder (ASD) within Arm B Precision Sub-study |
| Arm B - Typical Development (TD) - Not ASD | – | Device: Autism Pupil Screen (APS) Detect PLR Assessment #1, Other: Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT/R-F), Other: Social Responsiveness Scale, Second Edition (SRS-2), Diagnostic Test: Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), Other: Mullen Scales of Early Learning (MSEL), Other: Adaptive Behavior Assessment System, Third Edition (ABAS-3), Device: Autism Pupil Screen (APS) Detect PLR Assessment #2, Device: Autism Pupil Screen (APS) Detect Assessment #3, Procedure: Well-child checkParticipants without Autism Spectrum Disorder (ASD) within Arm B Precision Sub-study |
Who may qualify
- Ages
- 24 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children and their parents/legal guardians in Washington and Idaho
Key inclusion criteria (1 listed)
- Children between 24 months and 60 months of age
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autism Pupil Screen (APS) Detect PLR Assessment #1The 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. | Device | Arm A - Autism Spectrum Disorder (ASD), Arm A - Typical Development (TD) - Not ASD, Arm B - Autism Spectrum Disorder (ASD), Arm B - Typical Development (TD) - Not ASD |
| 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. | Other | Arm A - Autism Spectrum Disorder (ASD), Arm A - Typical Development (TD) - Not ASD, Arm B - Autism Spectrum Disorder (ASD), Arm B - Typical Development (TD) - Not 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. | Other | Arm A - Autism Spectrum Disorder (ASD), Arm A - Typical Development (TD) - Not ASD, Arm B - Autism Spectrum Disorder (ASD), Arm B - Typical Development (TD) - Not ASD |
| Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)Also: ADOS-2 - Toddler Module, ADOS-2 - Module 1, ADOS-2 - Module 2, ADOS-2 - Module 3A 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. | Diagnostic test | Arm A - Autism Spectrum Disorder (ASD), Arm A - Typical Development (TD) - Not ASD, Arm B - Autism Spectrum Disorder (ASD), Arm B - Typical Development (TD) - Not 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. | Other | Arm A - Autism Spectrum Disorder (ASD), Arm A - Typical Development (TD) - Not ASD, Arm B - Autism Spectrum Disorder (ASD), Arm B - Typical Development (TD) - Not ASD |
| 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. | Other | Arm A - Autism Spectrum Disorder (ASD), Arm A - Typical Development (TD) - Not ASD, Arm B - Autism Spectrum Disorder (ASD), Arm B - Typical Development (TD) - Not ASD |
| Autism Pupil Screen (APS) Detect PLR Assessment #2The 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. | Device | Arm B - Autism Spectrum Disorder (ASD), Arm B - Typical Development (TD) - Not ASD |
| Autism Pupil Screen (APS) Detect Assessment #3The 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. | Device | Arm B - Autism Spectrum Disorder (ASD), Arm B - Typical Development (TD) - Not ASD |
| Well-child checkA 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. | Procedure or surgery | Arm A - Autism Spectrum Disorder (ASD), Arm A - Typical Development (TD) - Not ASD, Arm B - Autism Spectrum Disorder (ASD), Arm B - Typical Development (TD) - Not ASD |
Primary outcome
Sensitivity and Specificity of the APS Score to classify ASD diagnostic outcome
Time frame: From enrollment to the end of all testing visits will be 14-30 days
This study will test the effectiveness of the APS Detect device results to accurately identify an atypical PLR score for children meeting the criteria for ASD. The study will also test the effectiveness of the APS Detect device results to accurately identify a typical PLR score for children who do not have ASD and have been identified as typically developing.
1 secondary outcome
Positive Predictive Values and Negative Predictive Values
Time frame: From enrollment to the end of all testing visits will be 14-30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 25750705Nystrom P, Gredeback G, Bolte S, Falck-Ytter T; EASE team. Hypersensitive pupillary light reflex in infants at risk for autism. Mol Autism. 2015 Mar 3;6:10. doi: 10.1186/s13229-015-0011-6. eCollection 2015.
- Background: PubMed 31562252Guthrie W, Wallis K, Bennett A, Brooks E, Dudley J, Gerdes M, Pandey J, Levy SE, Schultz RT, Miller JS. Accuracy of Autism Screening in a Large Pediatric Network. Pediatrics. 2019 Oct;144(4):e20183963. doi: 10.1542/peds.2018-3963.
- Background: PubMed 29087041Lynch GTF, James SM, VanDam M. Pupillary Response and Phenotype in ASD: Latency to Constriction Discriminates ASD from Typically Developing Adolescents. Autism Res. 2018 Feb;11(2):364-375. doi: 10.1002/aur.1888. Epub 2017 Oct 31.
- Background: PubMed 25528080Daluwatte C, Miles JH, Sun J, Yao G. Association between pupillary light reflex and sensory behaviors in children with autism spectrum disorders. Res Dev Disabil. 2015 Feb;37:209-15. doi: 10.1016/j.ridd.2014.11.019. Epub 2014 Dec 17.
- Background: PubMed 28188684Dinalankara DMR, Miles JH, Nicole Takahashi T, Yao G. Atypical pupillary light reflex in 2-6-year-old children with autism spectrum disorders. Autism Res. 2017 May;10(5):829-838. doi: 10.1002/aur.1745. Epub 2017 Feb 11.
- Background: PubMed 29735992Nystrom P, Gliga T, Nilsson Jobs E, Gredeback G, Charman T, Johnson MH, Bolte S, Falck-Ytter T. Enhanced pupillary light reflex in infancy is associated with autism diagnosis in toddlerhood. Nat Commun. 2018 May 7;9(1):1678. doi: 10.1038/s41467-018-03985-4.
- Background: PubMed 30469373Lynch G. Using Pupillometry to Assess the Atypical Pupillary Light Reflex and LC-NE System in ASD. Behav Sci (Basel). 2018 Nov 21;8(11):108. doi: 10.3390/bs8110108.
- Individual participant dataSharing planned: Yes. De-identified participant data that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Georgina Lynch, PhD principal investigator
Schweitzer Engineering Laboratories, Inc. Washington State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Schweitzer Engineering Laboratories at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgina Lynch, PhD (509-334-8800, clinicaltrials@selinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of the APS Score to classify ASD diagnostic outcome (time frame: From enrollment to the end of all testing visits will be 14-30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07903675, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.