NCT05294705

The Autism Biomarkers Consortium for Clinical Trials: Confirmation Study

The Autism Biomarkers Consortium for Clinical Trials

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 565 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: —

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.

Detailed description

The goal of this consortium is to establish tools that can be used as biomarkers and/or sensitive and reliable objective assays of social function in autism spectrum disorder (ASD) clinical trials. Specifically, we aim to accelerate the development of effective treatments for social function in ASD by validating (a) outcome measures that will be sensitive and reliable assessments of response to treatment and (b) biomarkers in the domains of electroencephalography (EEG), eye-tracking (ET) and behavioral measures of social function to reduce heterogeneity of samples via stratification. The consortium will conduct a naturalistic, longitudinal study of school-aged (6-11 years) children with ASD and typical development (TD) with IQ ranging from 60-150 (ASD) and 80-150 (TD). Children will be assessed across three time points (T1: Baseline, T2: 6 weeks, T3: 24 weeks) using clinician and caregiver assessments along with a battery of conceptually related EEG and ET tasks and independent ratings of clinical status.

Conditions

• Autism Spectrum Disorder

Timeline

• Start date: 2022-04-11
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2022-03-24
• Last updated: 2025-09-18

Locations

5 sites across 1 country: United States