The Autism Biomarkers Consortium for Clinical Trials: Confirmation Study

NCT05294705 | Completed DMC

• 2 other identifiers: 2000031989U19MH108206
• Study Type: observational
• Target: 565
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Keywords

Biomarkers

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  24 weeks

Secondary Outcomes (15)

• Aberrant Behavior Checklist (ABC)

  Baseline, 6 weeks and 24 weeks

• Autism Impact Measure (AIM)

  Baseline, 6 weeks and 24 weeks

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

  Baseline

• Child and Adolescent Symptom Inventory 5 (CASI-5)

  Baseline and 24 weeks

• PDD Behavior Inventory (PDD-BI)

  Baseline, 6 weeks and 24 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

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 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):
• \. Any known environmental circumstance that is likely to account for autism in the proband.
• For TD Participants (only):

Sponsors & Collaborators

• Yale University: lead
• Boston Children's Hospital: collaborator
• Duke University: 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, 06519, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02445, United States

Location

Duke

Durham, North Carolina, 27708, United States

Location

Unviersity of Washington

Seattle, Washington, 98105, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood (DNA) samples will be collected from ASD participants and their biological parents at any timepoint after consent during this study. 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. Study staff will share samples and study data via the NDAR and NIH/NIMH Data Repositories to create a community resource accessible for use by all qualified investigators.

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
• Target Duration: 24 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Child Study Center

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 24, 2022
• Study Start: April 11, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

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)