ABC-CT Pre-School Feasibility Study

Completed

Conditions studied: Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT06413316

Run by

Yale University

People needed

50

Starts

2024-07-02

Expected to finish

2025-06-30

Last updated by the study team

2025-07-02

Who can join

Age: 3 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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.
• 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.
• 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 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):
• 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.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Yale Child Study Center — New Haven, Connecticut, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Duke University — Durham, North Carolina, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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