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

April 4, 2023 updated by: Yale University

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.

Study Overview

Status

Completed

Conditions

Detailed Description

All participants who were initially eligible for the main study will be eligible and invited to return regardless of their participation at T2/T3 or current medication/psychiatric status using an intent-to-treat model. The follow-up study will conduct one additional timepoint with participants who enrolled in the main study.

In the Follow-up Study of the Main Study ABC-CT cohort, the investigators will re-administer the biomarker and clinical batteries 2-5 years after original study enrollment. This will allow the investigators to:

  1. Assess long-term stability of the markers, extending the analyses of reliability and consistency from the first phase of the consortium.
  2. Perform a more robust assessment of sensitivity to change, taking advantage of a longer developmental window in which participants are expected to exhibit greater clinical progression.
  3. Evaluate the longitudinal predictive value of the biomarkers by examining the association of their baseline values with later measures of social function.

Study Type

Observational

Enrollment (Actual)

265

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • New Haven, Connecticut, United States, 06512
        • Yale University Child Study Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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
  • If parents are biological, a minimum of the child and one parent (if accompanying the child at study visits) will be required to participate in the blood draw procedure. It is preferred that the child and both biological parents participate in the blood draw procedure, but the inability to obtain blood samples from trios will not be exclusionary.

Exclusion Criteria:

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.
  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Typical Development
Typically Developing (TD) participants from each site will be roughly matched by age and sex to the ASD group.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N170 Latency to Upright Human Faces
Time Frame: 5 years
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)
Time Frame: 5 years
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
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: James McPartland, PhD, Yale University Child Study Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2021

Primary Completion (Actual)

August 11, 2022

Study Completion (Actual)

August 11, 2022

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1509016477_b
  • U19MH108206 (U.S. NIH Grant/Contract)
  • U01FD006888 (U.S. FDA Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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