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Brain and eye tests could revolutionize autism research

NCT ID NCT05294705

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This completed study from Yale University enrolled 565 children aged 6-11, both with and without autism, to confirm whether certain brain wave and eye-tracking measures can serve as reliable biomarkers. The goal is to provide objective tools for future clinical trials to measure social function more accurately. No treatment was tested; the focus was on validating measurement methods.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide reliable tools for measuring social function in autism, making future clinical trials more efficient and accurate.
What could go wrong
This is an observational study, not a treatment trial. The measures may not prove sensitive enough for clinical use, and results may not apply to all age groups or autism severities.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

565 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

6 to 11 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: For All Subjects: 1. 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). 2. Written parental permission, and child assents when applicable, obtained prior to any study procedures. 3. IQ 60-150 (ASD) and 80-150 (TD) as assessed by the Differential Ability Scales - 2nd Edition. 4. Participant and parent/guardian must be English speaking. For ASD Participants (only): 1. 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. 2. 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. Exclusion Criteria: For All Subjects: 1. Known genetic or neurological syndrome with an established link to autism (in addition to ASD for ASD participants) 1. 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). 2. Specific cases will be discussed with the clinical team who will make a final determination, as needed. 2. History of epilepsy or seizure disorder a. 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. 3. 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. 4. Children who are taking neurological or psychiatric medications that are not stable on prescription or dose for 8 weeks prior to T1D1. a. 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. 5. History of significant prenatal/perinatal/birth injury as defined by birth \<36 weeks AND weight \<2000 grams (approximately 4.5.lbs). 6. History of neonatal brain damage. (e.g., with diagnosed hypoxic or ischemic event). 7. Any other factor that the investigator feels would make assessment or measurement performance invalid. 8. 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): 1. Known historical diagnosis of ASD or a sibling with ASD. 2. Criteria score in the ASD range on the ADOS/BOSA at T1 3. Active psychiatric disorder (depression, anxiety, ADHD, etc.) and/or any current treatment (medication or other treatment) for a psychiatric condition. 1. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02445, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Duke

    Durham, North Carolina, 27708, United States

  • Unviersity of Washington

    Seattle, Washington, 98105, United States

  • Yale Child Study Center

    New Haven, Connecticut, 06519, United States

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