ABC-CT Pre-School Feasibility Study

NCT06413316 | Completed DMC

• 2 other identifiers: 20000369742U19MH108206-05
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Autism Spectrum Disorder

Keywords

Biomarker

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  1 Month

Secondary Outcomes (18)

• Aberrant Behavior Checklist (ABC)

  Baseline

• Autism Impact Measure (AIM)

  Baseline

• Behavior Assessment System for Children -3 (BASC-3)

  Baseline

• PDD Behavior Inventory (PDD-BI)

  Baseline

• Social Responsiveness Scale 2 (SRS-2)

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

aged 3-5, with IQ ranging from 60-150, recruited from 5 clinical implementation sites in the US.

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.

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.
• 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.

Sponsors & Collaborators

• Yale University: lead
• Duke University: collaborator
• Boston Children's Hospital: collaborator
• Children's Hospital Los Angeles: collaborator
• University of Washington: collaborator
• Food and Drug Administration (FDA): collaborator
• University of Alabama at Birmingham: collaborator
• University of California, Los Angeles: collaborator
• Seattle Children's Hospital: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (5)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Yale Child Study Center

New Haven, Connecticut, 06510, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02445, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biological samples (blood) will be obtained for DNA analysis from both ASD participants and their biological parents after consent. All biospecimens will be collected and shipped as defined by the Biospecimen Standard Operating Procedure. Briefly, blood samples can be collected by an appropriately trained research staff member, traveling phlebotomist, or at a clinic. A parent and a trained laboratory member may help alleviate any anxiety the child might have, including by the use of numbing cream or cooling spray as standard practice. Participants with ASD and their biological parent(s) will each have up to 30 mL of blood drawn. Blood draws for this study will be conducted in accordance with NIH guidelines.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• James McPartland, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 14, 2024
• Study Start: July 2, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data is uploaded every 6 months throughout the study.
• Access Criteria: Per NDA access requirements.

Locations

US (5)