Autism Spectrum DisorderNCT06413316
ABC-CT Pre-School Feasibility Study
An observational study of Autism Spectrum Disorder, run by Yale University at 5 sites in United States.
Trial summary
This is a multicenter study that aims to determine whether the EEG and ET experiments studied in the ABC-CT Phase 1 and ABC-CT Confirmation studies can be successfully used with 3-5-year-old children and to determine the viability of these measures as potential biomarkers in 3-5-year-old children with ASD. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Jul 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: aged 3-5, with IQ ranging from 60-150, recruited from 5 clinical implementation sites in the US.
Who may be able to join
- For All Subjects:
- Children (regardless of biological sex) Age 3 - 5. Participants must be able to complete the study before turning 6.
- Written parental permission will be obtained prior to any study procedures. Child verbal assent will be obtained.
- IQ 60-150 (ASD) and 80-150 (TD) as assessed by the Differential Ability Scales - 2nd Edition or developmental level via Mullen Scales of Early Learning Composite (ELC).
- Participant and parent/guardian must be English speaking.
- For ASD Participants (only):
- Diagnosis of ASD based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the BOSA or Autism Diagnostic Observation Schedule (ADOS-2) and short form (ADI-R) scored age appropriately. Diagnostic evaluations will be completed by research staff and supervised by a licensed psychologist.
- If parents are biological, a minimum of the child and one parent will be required to consent to the blood draw procedure. It is preferred that the child and both biological parents participate in the blood draw procedure. The inability to obtain blood samples will not be exclusionary.
Who cannot join
- For All Subjects:
- Known genetic or neurological syndrome with an established link to autism (in addition to ASD for ASD participants)
- This does not include events in which the link to ASD is less well known/established (e.g., 16p11.2 CNVs, CHD8 mutations, Trisomy 21, 22q deletion syndrome, Dup 15q Syndrome).
- Specific cases will be discussed with the clinical team who will make a final determination, as needed.
- History of epilepsy or seizure disorder
- This does not include history of simple febrile seizures or if the child is seizure free (regardless of the seizure type) for the past year.
Show all 19Show fewer
- Motor or sensory impairment that would interfere with the valid completion of study measures including significant hearing or vision impairment not correctable by a hearing aid or glasses/contact lenses. Children who wear bifocal or progressive lenses are not eligible.
- Children who are taking neurological or psychiatric medications that are not stable on prescription or dose for 8 weeks prior to D1.
- Medication is not exclusionary. Children taking neurological or psychiatric medications, including anti epileptics and psychopharmacological agents, must be stable on the medication and dose for 8 weeks prior to D1.
- History of significant prenatal/perinatal/birth injury as defined by birth <36 weeks AND weight <2000 grams (approximately 4.5.lbs).
- History of neonatal brain damage. (e.g., with diagnosed hypoxic or ischemic event).
- Any other factor that the investigator feels would make assessment or measurement performance invalid.
- For ASD Participants (only):
- 1. Any known environmental circumstances that is likely to account for the picture of autism in the proband (severe nutritional or psychological deprivation etc.)
- For TD Participants (only):
- Known historical diagnosis of ASD or a sibling with ASD.
- Criteria score in the ASD range on the BOSA/ADOS
- Active psychiatric disorder (depression, anxiety, ADHD, etc.) and/or any current treatment (medication or other treatment) for a psychiatric condition.
- Participants will be screened using the (ECI-5 or CSI-4). Due to the instrument's high sensitivity and potential for false positives, any score in the clinical range will be reviewed by research staff for determination of eligibility.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Boston Children's Hospital
Boston, Massachusetts, 02445
Duke University
Durham, North Carolina, 27708
Children's Hospital Los Angeles
Los Angeles, California, 90027
Yale Child Study Center
New Haven, Connecticut, 06510
University of Washington
Seattle, Washington, 98195
About this study
Official title: Autism Biomarkers Consortium for Clinical Trials (ABC-CT) Pre-School Feasibility Study
This is a multicenter study that aims to determine whether the EEG and ET experiments studied in the ABC-CT Phase 1 and ABC-CT Confirmation studies can be successfully used with 3-5-year-old children and to determine the viability of these measures as potential biomarkers in 3-5-year-old children with ASD. Blood (DNA) samples will be collected from participants with ASD and biological parents for future genomic analyses, and raw, processed, and analyzed data will be shared to create a community resource accessible for use by all qualified investigators. These objectives are designed to advance the long term objective of developing promising biomarkers via the FDA Biomarker Qualification Program. This feasibility study aims to enroll 25 ASD and 25 TD eligible participants who are 3-5 years old.
Read the detailed description
The ABC-CT Pre-School Feasibility Study will collect data in a cohort of participants to determine feasibility of the measures used in the ABC-CT Phase 1 study and ABC-CT Confirmation study in 3-5 year old participants. We will be able to examine distributional and psychometric properties of the measures in this group and obtain preliminary estimates of group differences and associations with clinical measures. In addition, we aim to determine the viability of EEG and ET measures as potential biomarkers in 3-5-year-old children with ASD. Viability will be evaluated in terms of (a) valid data acquisition, including adequate levels of participant compliance, (b) reliability of data collection across sites, (c) construct validity in relation to social function, and (d) distributional/psychometric properties.
Primary Objectives:
- To evaluate the feasibility of collecting EEG and ET assessments used in the Phase 1 and Confirmation studies in 3-5 year old.
- To determine the viability of adapted EEG and ET measures as potential biomarkers in 3-5-year-old children with ASD and TD. To further evaluate the psychometric properties of the ET and EEG biomarkers in the 3-5 year old population.
Secondary Objectives:
- To collect blood samples from all ASD subjects and their biological parents for future genomic analyses and to share raw, processed, and analyzed data via the National Database for Autism Research (NDAR) and National Institute of Health / National Institute of Mental Health (NIH/NIMH) Data Repositories to create a community resource accessible for use by all qualified investigators.
- To compare estimates of key distributional parameters across the original, confirmation and feasibility samples to determine whether the markers profiles are sufficiently compatible to use in studies combining pre-school and school-aged children.
The Preschool Feasibility sample will be evenly divided (25 ASD, 25 TD), aged 3-5, with IQ ranging from 60-150, recruited from 5 clinical implementation sites in the US.
Endpoints:
To collect and analyze a new cohort of participants to evaluate the feasibility of ET and EEG acquisition in 3-5 year olds. We will also evaluate ET and EEG measures for potential utility as biomarkers in clinical trials. Primary endpoints include evaluation of (1) Acquisition, (2) Construct Validity, (3) Discriminant Validity.
Primary Biomarker Outcome Variables.
- N170 Latency to Upright Human Faces: The N170 Latency to Upright Human Faces (N170 latency) is a scalp recorded EEG event-related potential (ERP) component elicited by perception of the upright human face. Recorded over the posterior-temporal right hemisphere, the latency (or speed) of the peak of the N170 ERP component occurs at approximately 200 msec in children aged 3 to 5 years of age.
- Oculomotor Index of Gaze to Human Faces (OMI): Onscreen gaze position data, reflected in percentage of foveation (angling of the eyes to focus on a particular object) to human faces (Face%) relative to total valid foveation time across three assays.
- Conditions
- Autism Spectrum Disorder
- Keywords
- Biomarker
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder | During Screening Visits, Diagnosis of ASD will be based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the BOSA or Autism Diagnostic Observation Schedule (ADOS-2) and short form (ADI-R) scored age appropriately. Diagnostic evaluations will be completed by research staff and supervised by a licensed psychologist. | |
| Typical Development | Typically Developing (TD) participants from each site will be roughly matched by age and sex to the ASD group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
N170 Latency to Upright Human Faces
The N170 Latency to Upright Human Faces (N170 latency) is a scalp recorded EEG event-related potential (ERP) component elicited by perception of the upright human face. Recorded over the posterior-temporal right hemisphere, the latency (or speed) of the peak of the N170 ERP component occurs at approximately 200 msec in children aged 6 to 11 years of age and will be later in 3 to 5 year old children.
Measured: Baseline
N170 Latency to Upright Human Faces
The N170 Latency to Upright Human Faces (N170 latency) is a scalp recorded EEG event-related potential (ERP) component elicited by perception of the upright human face. Recorded over the posterior-temporal right hemisphere, the latency (or speed) of the peak of the N170 ERP component occurs at approximately 200 msec in children aged 6 to 11 years of age and will be later in 3 to 5 year old children.
Measured: 1 Month
Oculomotor Index of Gaze to Human Faces (OMI)
Onscreen gaze position data, reflected in percentage of foveation (angling of the eyes to focus on a particular object) to human faces (Face%) relative to total valid foveation time across three assays.
Measured: Baseline
Oculomotor Index of Gaze to Human Faces (OMI)
Onscreen gaze position data, reflected in percentage of foveation (angling of the eyes to focus on a particular object) to human faces (Face%) relative to total valid foveation time across three assays.
Measured: 1 Month
Secondary outcomes (18)
Aberrant Behavior Checklist (ABC)
The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors of children and adults with neurodevelopmetnal disorder at home, in residential facilities, ICFs/MR, and work training centers. It is also useful for classifying problem behaviors of children and adolescents with neurodevelopmetnal disorder in educational settings, residential and community-based facilities, and developmental centers
Measured: Baseline
Autism Impact Measure (AIM)
The Autism Impact Measure (AIM) uses a 2-week recall period with items rated on two corresponding 5-point scales (frequency and impact)
Measured: Baseline
Behavior Assessment System for Children -3 (BASC-3)
The Behavior Assessment System for Children, Third Edition (BASC-3) offers several different forms designed to aid in collecting information regarding at-risk adaptive behavioral and/or emotional problems.
Measured: Baseline
PDD Behavior Inventory (PDD-BI)
The PDD-BI is an assessment tool for children on the autism spectrum. PDDBI profiles can provide guidance to clinicians regarding the child's problems as perceived by the informants, how a particular child compares to most children their age with ASD, and the skills and abilities of the child.
Measured: Baseline
Social Responsiveness Scale 2 (SRS-2)
The Social Responsiveness Scale 2 (SRS-2) is completed in just 15 to 20 minutes and identifies social impairment associated with autism spectrum disorders (ASDs) and quantifies its severity.
Measured: Baseline
Cognitive Assessment
Differential Ability Scales - Second Edition; DAS-II (Elliott C, 2007): The DAS-II is a clinical instrument designed to assess cognitive ability include variables such as verbal cluster, spatial cluster, nonverbal cluster, special nonverbal composite
Measured: Baseline
Resting State EEG
Resting State EEG (Eyes Open) provides a reference for the event-related EEG measures and a baseline biomarker of EEG spectral power across frequencies, neurofunctional connectivity and coherence, and hemispheric asymmetry and will always be done prior to the other EEG paradigms. Participants will be presented with non-social, abstract moving videos in random order.
Measured: Baseline
Faces Processing EEG
Faces processing is a foundation for social perception and attention and serves as a promising and robust biomarker of social impairment in ASD and a potential index of subgroup differences. As the primary non-resting paradigm, the FACES task will always
Measured: Baseline
Kaufman Assessment Battery for Children (K-ABC Face Recognition)
The Kaufman Assessment Battery for Children (KABC) is a clinical instrument (psychological diagnostic test) for assessing cognitive development. Its construction incorporates several recent developments in both psychological theory and statistical methodology.
Measured: Baseline
Emotional Competence Inventory (ECI)
The Emotional Competence Inventory 2.0 (ECI) measures 18 competencies organized into four clusters: Self-Awareness, Self-Management, Social Awareness, and Relationship Management. The Emotional Competence Inventory takes approximately 30-45 minutes to complete.
Measured: Baseline
Mullen Scales of Early Learning
Mullen Scales of Early Learning is a developmentally integrated system that assesses language, motor, and perceptual abilities, measures cognitive ability and motor development quickly and reliability.
Measured: Baseline
VABS: Vineland Adaptive Behavior Scales- III Socialization
Administered in person visit or via parent phone interview. The Socialization score is based on 3 subdomains of Interpersonal Relationships, Play \& Leisure, Coping Scales. The V-Scaled scores, which are specifically designed to measure change over time, are only available for the subdomains. The primary norm-referenced scores for the subdomains are v-scale scores, which have a mean of 15 and standard deviation (SD) of 3. The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives.
Measured: Baseline
Eye-tracking (ET) Static Social Scenes Task
ET Paradigms will be administered in counterbalanced blocks, one on each day of each screening or study visits. Both blocks will include all the tasks but in different orders. The length of individual paradigms ranges from 1 to 8.5 mins. Color images depicting 12 different female faces with direct gaze and the same faces with averted gaze will be presented. Twelve different exemplars from each of five categories (alarm clocks, mobile phones, birds, cars, and shoes) will be used as distracters. Twelve different slides will each contain six images (one face and five distracters, one from each category) placed at an equal distance from the center of the screen. Each slide contains a different set of six images, each image being shown only once in the experiment. This measure examines scanning patterns towards arrays of objects, synthetic stimuli, and faces as well as towards more complex naturalistic (static) scenes. This task examines complex scene processing and attentional selection.
Measured: Baseline
Eye-tracking (ET) Pupillary Light Reflex Task
ET Paradigms will be administered in counterbalanced blocks, one on each day of each screening or study visits. Both blocks will include all the tasks but in different orders. The length of individual paradigms ranges from 1 to 8.5 mins.
Pupillary Light Reflex (PLR) Task is measured following a stimuli that consist of a central fixation point on a black background that flashes white for 133 milliseconds. The constriction of the pupil in response to a bright flash indexes function of the parasympathetic nervous system.
Measured: Baseline
Eye-tracking (ET) Social Interactive Task
ET Paradigms will be administered in counterbalanced blocks, one on each day of each screening or study visits. Both blocks will include all the tasks but in different orders. The length of individual paradigms ranges from 1 to 8.5 mins.
Interactive Social Task (IST) is taps similar constructs as the activity monitoring task in a more naturalistic, dynamic, and complex context. Following a central fixation, children will be presented with interactive social trails in which two children engage in a natural interactive play session.
Measured: Baseline
Eye-Tracking (ET) Activity Monitoring Task
ET Paradigms will be administered in counterbalanced blocks, one on each day of each screening or study visits. Both blocks will include all the tasks but in different orders. The length of individual paradigms ranges from 1 to 8.5 mins.
Activity Monitoring Task is measured following central fixation. Children will be presented with multiple activity monitoring trails depicting two actresses engaging in a controlled joint activity such as assembling a puzzle.
Measured: Baseline
Visual Evoked Potentials (VEPs) EEG
Visual Evoked Potentials (VEPs) index low-level visual processing and reflect the functional integrity of the visual pathway. VEPs reflect excitatory (glutamatergic) and inhibitory (GABAergic) activity and may index subgroups of ASD with low-level visual impairments. VEPs also serve as a control for assessment of higher-order activity in social visual paradigms. Subjects will be presented with black and white checkerboards that reverse phase at a defined interval. The order of the VEP and Biomotion paradigms will be counterbalanced.
Measured: Baseline
Child Symptom Inventory-4 (CSI-4)
(CSI-4) is a behavior rating scale for evaluating the symptoms of DSM-IV and DSM-5 emotional and behavioral disorders among children between 5 and 12 years old who are attending elementary school (kindergarten thru 6th grade). There are both parent- and teacher-completed versions. The CSI-4: Parent Checklist contains 97 items for over a dozen emotional and behavioral disorders, and the CSI-4: Teacher Checklist contains 77 items. The CSI-4 can be scored to derive symptom count cutoff scores (diagnostic model) or symptom severity scores (T scores based on a dimensional model). Scoring is quick and easy with user-friendly score sheets.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start2 Jul 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Boston Children's Hospital, Children's Hospital Los Angeles, University of Washington, Food and Drug Administration (FDA), University of Alabama at Birmingham, University of California, Los Angeles, Seattle Children's Hospital, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- James McPartland, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413316
- Sponsor's protocol ID
- 2000036974
- Other IDs
- 2U19MH108206-05
- Status last verified
- Jun 2025
- First submitted
- 8 May 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be uploaded to the National Institute of Mental Health Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Biomarkers Consortium for Clinical Trials (ABC-CT) Pre-School Feasibility Study
- ClinicalTrials.gov ID
- NCT06413316
- Acronym / sponsor ID
- 2000036974
- Conditions
- Autism Spectrum Disorder
- Keywords
- Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Duke University, Boston Children's Hospital, Children's Hospital Los Angeles, University of Washington, Food and Drug Administration (FDA), University of Alabama at Birmingham, University of California, Los Angeles, Seattle Children's Hospital, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 14 May 2024 (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.
This is a multicenter study that aims to determine whether the EEG and ET experiments studied in the ABC-CT Phase 1 and ABC-CT Confirmation studies can be successfully used with 3-5-year-old children and to determine the viability of these measures as potential biomarkers in 3-5-year-old children with ASD. Blood (DNA) samples will be collected from participants with ASD and biological parents for future genomic analyses, and raw, processed, and analyzed data will be shared to create a community resource accessible for use by all qualified investigators. These objectives are designed to advance the long term objective of developing promising biomarkers via the FDA Biomarker Qualification Program. This feasibility study aims to enroll 25 ASD and 25 TD eligible participants who are 3-5 years old.
Detailed description
The ABC-CT Pre-School Feasibility Study will collect data in a cohort of participants to determine feasibility of the measures used in the ABC-CT Phase 1 study and ABC-CT Confirmation study in 3-5 year old participants. We will be able to examine distributional and psychometric properties of the measures in this group and obtain preliminary estimates of group differences and associations with clinical measures. In addition, we aim to determine the viability of EEG and ET measures as potential biomarkers in 3-5-year-old children with ASD. Viability will be evaluated in terms of (a) valid data acquisition, including adequate levels of participant compliance, (b) reliability of data collection across sites, (c) construct validity in relation to social function, and (d) distributional/psychometric properties.
Primary Objectives:
- To evaluate the feasibility of collecting EEG and ET assessments used in the Phase 1 and Confirmation studies in 3-5 year old.
- To determine the viability of adapted EEG and ET measures as potential biomarkers in 3-5-year-old children with ASD and TD. To further evaluate the psychometric properties of the ET and EEG biomarkers in the 3-5 year old population.
Secondary Objectives:
- To collect blood samples from all ASD subjects and their biological parents for future genomic analyses and to share raw, processed, and analyzed data via the National Database for Autism Research (NDAR) and National Institute of Health / National Institute of Mental Health (NIH/NIMH) Data Repositories to create a community resource accessible for use by all qualified investigators.
- To compare estimates of key distributional parameters across the original, confirmation and feasibility samples to determine whether the markers profiles are sufficiently compatible to use in studies combining pre-school and school-aged children.
The Preschool Feasibility sample will be evenly divided (25 ASD, 25 TD), aged 3-5, with IQ ranging from 60-150, recruited from 5 clinical implementation sites in the US.
Endpoints:
To collect and analyze a new cohort of participants to evaluate the feasibility of ET and EEG acquisition in 3-5 year olds. We will also evaluate ET and EEG measures for potential utility as biomarkers in clinical trials. Primary endpoints include evaluation of (1) Acquisition, (2) Construct Validity, (3) Discriminant Validity.
Primary Biomarker Outcome Variables.
- N170 Latency to Upright Human Faces: The N170 Latency to Upright Human Faces (N170 latency) is a scalp recorded EEG event-related potential (ERP) component elicited by perception of the upright human face. Recorded over the posterior-temporal right hemisphere, the latency (or speed) of the peak of the N170 ERP component occurs at approximately 200 msec in children aged 3 to 5 years of age.
- Oculomotor Index of Gaze to Human Faces (OMI): Onscreen gaze position data, reflected in percentage of foveation (angling of the eyes to focus on a particular object) to human faces (Face%) relative to total valid foveation time across three assays.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder | – | –During Screening Visits, Diagnosis of ASD will be based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the BOSA or Autism Diagnostic Observation Schedule (ADOS-2) and short form (ADI-R) scored age appropriately. Diagnostic evaluations will be completed by research staff and supervised by a licensed psychologist. |
| Typical Development | – | –Typically Developing (TD) participants from each site will be roughly matched by age and sex to the ASD group. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- aged 3-5, with IQ ranging from 60-150, recruited from 5 clinical implementation sites in the US.
Key inclusion criteria (8 listed)
- Children (regardless of biological sex) Age 3 - 5. Participants must be able to complete the study before turning 6.
- Written parental permission will be obtained prior to any study procedures. Child verbal assent will be obtained.
- IQ 60-150 (ASD) and 80-150 (TD) as assessed by the Differential Ability Scales - 2nd Edition or developmental level via Mullen Scales of Early Learning Composite (ELC).
- Participant and parent/guardian must be English speaking.
- Diagnosis of ASD based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the BOSA or Autism Diagnostic Observation Schedule (ADOS-2) and short form (ADI-R) scored age appropriately. Diagnostic evaluations will be completed by research staff and supervised by a licensed psychologist.
Key exclusion criteria (19 listed)
- Known genetic or neurological syndrome with an established link to autism (in addition to ASD for ASD participants)
- History of epilepsy or seizure disorder
- Motor or sensory impairment that would interfere with the valid completion of study measures including significant hearing or vision impairment not correctable by a hearing aid or glasses/contact lenses. Children who wear bifocal or progressive lenses are not eligible.
- Children who are taking neurological or psychiatric medications that are not stable on prescription or dose for 8 weeks prior to D1.
- History of significant prenatal/perinatal/birth injury as defined by birth <36 weeks AND weight <2000 grams (approximately 4.5.lbs).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
N170 Latency to Upright Human Faces
Time frame: Baseline
The N170 Latency to Upright Human Faces (N170 latency) is a scalp recorded EEG event-related potential (ERP) component elicited by perception of the upright human face. Recorded over the posterior-temporal right hemisphere, the latency (or speed) of the peak of the N170 ERP component occurs at approximately 200 msec in children aged 6 to 11 years of age and will be later in 3 to 5 year old children.
N170 Latency to Upright Human Faces
Time frame: 1 Month
The N170 Latency to Upright Human Faces (N170 latency) is a scalp recorded EEG event-related potential (ERP) component elicited by perception of the upright human face. Recorded over the posterior-temporal right hemisphere, the latency (or speed) of the peak of the N170 ERP component occurs at approximately 200 msec in children aged 6 to 11 years of age and will be later in 3 to 5 year old children.
Oculomotor Index of Gaze to Human Faces (OMI)
Time frame: Baseline
Onscreen gaze position data, reflected in percentage of foveation (angling of the eyes to focus on a particular object) to human faces (Face%) relative to total valid foveation time across three assays.
Oculomotor Index of Gaze to Human Faces (OMI)
Time frame: 1 Month
Onscreen gaze position data, reflected in percentage of foveation (angling of the eyes to focus on a particular object) to human faces (Face%) relative to total valid foveation time across three assays.
18 secondary outcomes
Aberrant Behavior Checklist (ABC)
Time frame: Baseline
Autism Impact Measure (AIM)
Time frame: Baseline
Behavior Assessment System for Children -3 (BASC-3)
Time frame: Baseline
PDD Behavior Inventory (PDD-BI)
Time frame: Baseline
Social Responsiveness Scale 2 (SRS-2)
Time frame: Baseline
Cognitive Assessment
Time frame: Baseline
Resting State EEG
Time frame: Baseline
Faces Processing EEG
Time frame: Baseline
Kaufman Assessment Battery for Children (K-ABC Face Recognition)
Time frame: Baseline
Emotional Competence Inventory (ECI)
Time frame: Baseline
Mullen Scales of Early Learning
Time frame: Baseline
VABS: Vineland Adaptive Behavior Scales- III Socialization
Time frame: Baseline
Eye-tracking (ET) Static Social Scenes Task
Time frame: Baseline
Eye-tracking (ET) Pupillary Light Reflex Task
Time frame: Baseline
Eye-tracking (ET) Social Interactive Task
Time frame: Baseline
Eye-Tracking (ET) Activity Monitoring Task
Time frame: Baseline
Visual Evoked Potentials (VEPs) EEG
Time frame: Baseline
Child Symptom Inventory-4 (CSI-4)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: Yes. IPD will be uploaded to the National Institute of Mental Health Data Archive.
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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. This study is not recruiting at the moment.
James McPartland, PhD principal investigator
Yale University
5 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 Yale University at 5 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 8 inclusion and 19 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: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N170 Latency to Upright Human Faces (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2025.