Autism Spectrum DisorderABC-CT CSNCT05294705

The Autism Biomarkers Consortium for Clinical Trials: Confirmation Study

An observational study of Autism Spectrum Disorder, run by Yale University at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 6 to 11 years
Conditions the study is for: Autism Spectrum Disorder
How many people: 565 participants
Where: 5 sitesUnited States
Study dates: 11 Apr 2022to 31 Aug 2025
How long will I take part?: 24 Weeks
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 6 to 11 years
All sexes
Child

Study population: 200 children with an autism spectrum disorder (ASD) between 6-11 years old, and 200 typically developing children between 6-11 years old

Who may be able to join

For All Subjects:
Males and Females Age 6 - 11 (less than 11 years and 6 months old at T1D1 unless all study procedures will be completed before the participant turns 12.0 and prior approval by the Principal Investigator is obtained).
Written parental permission, and child assents when applicable, obtained prior to any study procedures.
IQ 60-150 (ASD) and 80-150 (TD) as assessed by the Differential Ability Scales - 2nd Edition.
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 Autism Diagnostic Observation Schedule (ADOS-2) or BOSA and the Autism Diagnostic Interview-Revised, short form (ADI-R). 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 20Show 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 T1D1.
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 T1D1.
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.
Participation in the original ABC-CT study.
For ASD Participants (only):
1. Any known environmental circumstance that is likely to account for autism in the proband.
For TD Participants (only):
Known historical diagnosis of ASD or a sibling with ASD.
Criteria score in the ASD range on the ADOS/BOSA at T1
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 Child/Adolescent Symptom Inventory (CASI- 5). 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.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Boston Children's Hospital
Boston, Massachusetts, 02445
Duke
Durham, North Carolina, 27708
Children's Hospital Los Angeles
Los Angeles, California, 90027
Yale Child Study Center
New Haven, Connecticut, 06519
Unviersity of Washington
Seattle, Washington, 98105

Other trials in United States

About this study

Official title: The Autism Biomarkers Consortium for Clinical Trials

This is a multicenter longitudinal study that aims to validate a set of measures that were previously identified as promising candidate biomarkers and/or sensitive and reliable objective measures of social function in ASD for potential use in clinical trials. The confirmation study will repeat the data collection and analysis protocols from the original ABC-CT study. This confirmation study will recruit 200 ASD and 200 TD comparison participants who are 6-11 years old, matching the overall sample size but providing a larger normative reference sample and greater statistical power for group comparisons.

Read the detailed description

The goal of this consortium is to establish tools that can be used as biomarkers and/or sensitive and reliable objective assays of social function in autism spectrum disorder (ASD) clinical trials. Specifically, we aim to accelerate the development of effective treatments for social function in ASD by validating (a) outcome measures that will be sensitive and reliable assessments of response to treatment and (b) biomarkers in the domains of electroencephalography (EEG), eye-tracking (ET) and behavioral measures of social function to reduce heterogeneity of samples via stratification. The consortium will conduct a naturalistic, longitudinal study of school-aged (6-11 years) children with ASD and typical development (TD) with IQ ranging from 60-150 (ASD) and 80-150 (TD). Children will be assessed across three time points (T1: Baseline, T2: 6 weeks, T3: 24 weeks) using clinician and caregiver assessments along with a battery of conceptually related EEG and ET tasks and independent ratings of clinical status.

Conditions: Autism Spectrum Disorder
Keywords: Biomarkers
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 groups in NCT05294705
Study group	Role	What they receive
Autism Spectrum Disorder		During Screening Visits, the Autism Diagnostic Observational Schedule (ADOS) will be administered to confirm diagnosis. Criteria for group inclusion is: diagnosis of Autism Spectrum Disorder based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the Autism Diagnostic Observation Schedule (ADOS-G), Brief Observation of Symptoms of Autism (BOSA), Childhood Autism Rating Scale-2(CARS-2) and the Autism Diagnostic Interview-Revised, short form (ADI-R). 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.
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: 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
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.
Measured: 6 weeks
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: 6 weeks
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: 6 weeks
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.
Measured: 24 weeks
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: 24 weeks
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: 24 weeks

Secondary outcomes (15)

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, 6 weeks and 24 weeks
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, 6 weeks and 24 weeks
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
Child and Adolescent Symptom Inventory 5 (CASI-5)
The Child \& Adolescent Symptom Inventory-5 (CASI-5) is a behavior rating scale for DSM-5-defined emotional and behavioral disorders in youths between 5 and 18 years old.
Measured: Baseline and 24 weeks
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, 6 weeks and 24 weeks
Social Responsiveness Scale 2 (SRS-2)
Baseline and 24 weeks
Measured: 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.
Cognitive Assessment
Baseline and 24 weeks
Measured: 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 and
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, 6 weeks and 24 weeks
Faces Processing EEG
Baseline, 6 weeks and 24 weeks
Measured: 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
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, 6 weeks and 24 weeks
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, 6 weeks and 24 weeks
Eye-tracking (ET) Interactive Social Task (IST)
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, 6 weeks and 24 weeks
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, 6 weeks and 24 weeks
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, 6 weeks and 24 weeks
NEPSY-II
NEPSY-II - Memory for Faces Subtest (administered to all ages): The NEPSY-II Memory for Faces subtest entails viewing a series of faces and having the child identify the sex of each face. The child is then shown three faces at a time and required to identify the previously seen face.
Measured: Baseline, 6 weeks and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Apr 202231 Aug 2025

First posted24 Mar 2022
Study start11 Apr 2022
Primary completion31 Aug 2025
Study completion31 Aug 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: 565 participants (actual)
Target duration: 24 Weeks

IDs, dates and publications

ClinicalTrials.gov ID: NCT05294705
Sponsor's protocol ID: 2000031989
Other IDs: U19MH108206
Acronym: ABC-CT CS
Status last verified: Sep 2025
First submitted: 11 Mar 2022
Last updated: 18 Sep 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 Archeive.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Autism Biomarkers Consortium for Clinical Trials
ClinicalTrials.gov ID: NCT05294705
Acronym / sponsor ID: ABC-CT CS / 2000031989
Conditions: Autism Spectrum Disorder
Keywords: Biomarkers
Study type: Observational
Recruitment status: Completed
Enrolment: 565 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Boston Children's Hospital, Duke University, 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: 11 Apr 2022 (actual)
Primary completion: 31 Aug 2025 (actual)
Study completion: 31 Aug 2025 (actual)
First posted: 24 Mar 2022 (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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Target follow-up: 24 Weeks
Number of arms: 2

Arm	Type	Receives
Autism Spectrum Disorder	–	–During Screening Visits, the Autism Diagnostic Observational Schedule (ADOS) will be administered to confirm diagnosis. Criteria for group inclusion is: diagnosis of Autism Spectrum Disorder based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the Autism Diagnostic Observation Schedule (ADOS-G), Brief Observation of Symptoms of Autism (BOSA), Childhood Autism Rating Scale-2(CARS-2) and the Autism Diagnostic Interview-Revised, short form (ADI-R). 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: 6 to 11 years
Sex: All
Age groups: Child
Study population: 200 children with an autism spectrum disorder (ASD) between 6-11 years old, and 200 typically developing children between 6-11 years old

Key inclusion criteria (8 listed)

Males and Females Age 6 - 11 (less than 11 years and 6 months old at T1D1 unless all study procedures will be completed before the participant turns 12.0 and prior approval by the Principal Investigator is obtained).
Written parental permission, and child assents when applicable, obtained prior to any study procedures.
IQ 60-150 (ASD) and 80-150 (TD) as assessed by the Differential Ability Scales - 2nd Edition.
Participant and parent/guardian must be English speaking.
Diagnosis of ASD based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the Autism Diagnostic Observation Schedule (ADOS-2) or BOSA and the Autism Diagnostic Interview-Revised, short form (ADI-R). Diagnostic evaluations will be completed by research staff and supervised by a licensed psychologist.

Key exclusion criteria (20 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 T1D1.
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.
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.
VABS: Vineland Adaptive Behavior Scales- III Socialization
Time frame: Baseline
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.
N170 Latency to Upright Human Faces
Time frame: 6 weeks
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.
Oculomotor Index of Gaze to Human Faces (OMI)
Time frame: 6 weeks
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.
VABS: Vineland Adaptive Behavior Scales- III Socialization
Time frame: 6 weeks
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.
N170 Latency to Upright Human Faces
Time frame: 24 weeks
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.
Oculomotor Index of Gaze to Human Faces (OMI)
Time frame: 24 weeks
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.
VABS: Vineland Adaptive Behavior Scales- III Socialization
Time frame: 24 weeks
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.

15 secondary outcomes

Aberrant Behavior Checklist (ABC)
Time frame: Baseline, 6 weeks and 24 weeks
Autism Impact Measure (AIM)
Time frame: Baseline, 6 weeks and 24 weeks
Behavior Assessment System for Children -3 (BASC-3)
Time frame: Baseline
Child and Adolescent Symptom Inventory 5 (CASI-5)
Time frame: Baseline and 24 weeks
PDD Behavior Inventory (PDD-BI)
Time frame: Baseline, 6 weeks and 24 weeks
Social Responsiveness Scale 2 (SRS-2)
Time frame: 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.
Cognitive Assessment
Time frame: 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 and
Resting State EEG
Time frame: Baseline, 6 weeks and 24 weeks
Faces Processing EEG
Time frame: 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
Visual Evoked Potentials (VEPs) EEG
Time frame: Baseline, 6 weeks and 24 weeks
Eye-Tracking (ET) Activity Monitoring Task
Time frame: Baseline, 6 weeks and 24 weeks
Eye-tracking (ET) Interactive Social Task (IST)
Time frame: Baseline, 6 weeks and 24 weeks
Eye-tracking (ET) Pupillary Light Reflex Task
Time frame: Baseline, 6 weeks and 24 weeks
Eye-tracking (ET) Static Social Scenes Task
Time frame: Baseline, 6 weeks and 24 weeks
NEPSY-II
Time frame: Baseline, 6 weeks and 24 weeks

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 18 Sep 2025.
Individual participant dataSharing planned: Yes. IPD will be uploaded to the National Institute of Mental Health Data Archeive.

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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 20 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 18 Sep 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 9 primary outcomes in all. 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 NCT05294705.

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 18 Sep 2025.