Brain and eye tests could revolutionize autism research
NCT ID NCT05294705
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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565 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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Aug 2025
- Lead sponsor
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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
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6 to 11 years
- Sex
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Anyone
Show the full entry requirements Hide 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
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Boston Children's Hospital
Boston, Massachusetts, 02445, United States
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Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
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Duke
Durham, North Carolina, 27708, United States
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Unviersity of Washington
Seattle, Washington, 98105, United States
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Yale Child Study Center
New Haven, Connecticut, 06519, United States
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