Autism Biomarker Consortium for Clinical Trials (ABC-CT): Follow-up Study

NCT04841525 | Completed DMC

• 3 other identifiers: 1509016477_bU01FD006888U19MH108206
• Study Type: observational
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter longitudinal follow-up study to the main study of an a registered already (NCT# ). The Follow-up Study (T4) will assess the Main Study cohort for an additional longitudinal time point approximately 2-5 years after the initial study. Children participating in the Follow-up Study will be approximately 8-16 years old. The aims of the main study is to identify, develop and validate a set of measures that can be used as stratification biomarkers and/or sensitive and reliable objective measures of social impairment in autism spectrum disorders (ASD) that could serve as markers of long term clinical outcome.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

• 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.

  5 years

• 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.

  5 years

• VABS: Vineland Adaptive Behavior Scales- III Socialization

  Administered in person visit during T4D1 or 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.

  5 years

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), 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
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

200 children with an autism spectrum disorder between 6-11 years old, and 75 typically developing children

You may qualify if:

• For All Subjects:
• Males and Females Age 6 - 11 (\<11:5 at timepoint #1 unless all study procedures will be completed before the participant turns 12.0 and prior approval by the Principal Investigator is obtained).
• Written parental consent obtained prior to any study procedures.
• Participant and parent/guardian must be English speaking.
• For TD Participants:
• IQ 80-150 as assessed by the Differential Ability Scales (DAS)- 2nd Edition
• For ASD Participants:
• Diagnosis of ASD based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the Autism Diagnostic Observation Schedule (ADOS-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.
• IQ 60-150 as assessed by the Differential Ability Scales (DAS)- 2nd Edition

You may not qualify if:

• For All Subjects:
• Known genetic or neurological syndrome with established link to autism (in addition to ASD for ASD participants), but not events in which the link to ASD is less well known/established (e.g., 16p11.2 CNVs, CHD8 mutations, Trisomy 21, 22q deletion syndrome)
• History of epilepsy or seizure disorder (except for history of simple febrile seizures or if the child is seizure free (regardless of 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.
• History of significant prenatal/perinatal/birth injury (birth \<36 weeks AND weight \<2000 grams (approximately 4.5lbs)).
• History of neonatal brain damage. (e.g., with diagnoses hypoxic or ischemic event)
• Any other factor that the investigator feels would make assessment or measurement performance invalid.
• For ASD Participants:
• Any known environmental circumstances that is likely to account for the picture of autism in the proband (severe nutritional or psychological deprivation etc.)
• For TDs Participants:
• Known historical diagnosis of ASD or a sibling with ASD.
• 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 Child/Adolescent Symptom Inventory (CASI-5). Due to the measurements sensitivity, any score in the clinical range will be reviewed by research staff for determination of eligibility.

Sponsors & Collaborators

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

Study Sites (1)

Yale University Child Study Center

New Haven, Connecticut, 06512, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• James McPartland, PhD

  Yale University Child Study Center

  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: April 7, 2021
• First Posted: April 12, 2021
• Study Start: April 9, 2021
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)