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

Autism Spectrum Disorder Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

• NCT number: NCT04841525
• Study type: Observational
• Source: Yale University
• Status: Completed
• Start date: April 9, 2021
• Completion date: August 11, 2022