An observational study in Autism Spectrum Disorder, sponsored by Schweitzer Engineering Laboratories. Recruiting at 4 sites in United States. Open to participants aged 24 Months to 60 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Schweitzer Engineering Laboratories · Observational
Among 772 studies in Autism Spectrum Disorder with a site in United States — 165 open to participants now, 204 under way, 9 of them phase 3. Autism Spectrum Disorder · United States.
Among the 772 studies in Autism Spectrum Disorder with a site in United States, this one is the 33rd largest by planned enrollment of the 113 observational ones that give a count, is one of 46 that started in 2026, is one of 113 observational ones, reaches primary completion later than 87 of the 202 other live ones, and was the 772nd registered.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
Browse Autism Spectrum Disorder studies →165 of the 772 studies in Autism Spectrum Disorder with a site in United States are open now. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Children's Hospital Medical Center, Cincinnati · Sites in United States
Bristol-Myers Squibb · Sites in United States, Australia, Canada and 1 more country
Bristol-Myers Squibb · Sites in United States, France, Germany and 7 more countries
Massachusetts General Hospital · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 349 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 294 (84%) stop at 75 or younger; 297 take children under 18; 92 take healthy volunteers.
This study: 24 Months to 60 Months · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
772 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 52 · Phase 2 117 · Phase 3 33 · Phase 4 16
First in 2004; this study’s year is marked. 46 started in 2026.
This study's planned enrollment of 330 is above the median of 102 across 320 observational studies indexed under Autism Spectrum Disorder.
Median enrollment 50 across the 658 interventional studies, 131 across the 113 observational. Of the 521 that completed or were terminated, 174 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
89 of 772 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Schweitzer Engineering Laboratories as lead sponsor.
Schweitzer Engineering Laboratories has 1 study filed under Autism Spectrum Disorder — fewer than ten, so there is no comparison to draw.
68 of the studies in Autism Spectrum Disorder with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06706674Phase 3Intra-Cellular Therapies, Inc.Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients | 2027-06-21 |
| NCT06690398Phase 3Intra-Cellular Therapies, Inc.Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients | 2027-06-21 |
| NCT07670000Natalia PoluektovaMental And Speech Developmental Delay Autism Spectrum-Type Behavioral Disorder | 2026-11 |
| NCT04242355Yale UniversityTranscranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder | 2026-12 |
| NCT06059352Loma Linda UniversitySleep and Central Auditory Processing Disorder in Autism Spectrum Disorder | 2026-12 |
Among the 772 studies in Autism Spectrum Disorder with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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 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).
Children and their parents/legal guardians in Washington and Idaho
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Participants with Autism Spectrum Disorder (ASD) within Arm A
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
Participants without Autism Spectrum Disorder (ASD) within Arm A
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
Participants with Autism Spectrum Disorder (ASD) within Arm B Precision Sub-study
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
Participants without Autism Spectrum Disorder (ASD) within Arm B Precision Sub-study
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
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.
Also known as: ADOS-2 - Toddler Module, ADOS-2 - Module 1, ADOS-2 - Module 2, ADOS-2 - Module 3
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.
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.
Time frame: From enrollment to the end of all testing visits will be 14-30 days
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.
Time frame: From enrollment to the end of all testing visits will be 14-30 days
Precision Study: Reliability and Reproducibility of the results of the APS Detect
Study participants selected for Arm B of this trial will be tested to evaluate how consistent the results are for the APS Detect. This part of the study will assess the percent of agreement between outcome measures obtained with the APS Detect over more than one administration of the pupil screening test administered by a different clinician for each test administration. A test of each individual pupil measurement that contributes to the APS Score will analyze the influence of those measurements on the final result obtained across study participants.
Time frame: From enrollment to the end of all testing visits will be 14-30 days
Plan to share: Yes — De-identified participant data that underlie results in a publication.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Six months after publication for a duration of three years.
Access criteria: Researchers affiliated with universities or research institutions may contact the study PI directly to request access. De-identified PLR data, study protocol, statistical/data analytic plan will be shared.
Started Oct 2026 (actual). Primary completion is estimated for Apr 2027, 5 months after the start.
Of 112 observational studies under Autism Spectrum Disorder, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 120. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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