The Autism Biomarkers Consortium for Clinical Trials: Confirmation Study
NCT05294705 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 565
Last updated 2025-09-18
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
Sponsors & Collaborators
- collaborator OTHER
- collaborator OTHER
-
Children's Hospital Los Angeles
collaborator OTHER - collaborator OTHER
-
Food and Drug Administration (FDA)
collaborator FED -
University of Alabama at Birmingham
collaborator OTHER -
University of California, Los Angeles
collaborator OTHER -
Seattle Children's Hospital
collaborator OTHER -
National Institutes of Health (NIH)
collaborator NIH -
National Institute of Mental Health (NIMH)
collaborator NIH -
Yale University
lead OTHER
Principal Investigators
-
James McPartland, PhD · Yale University
Eligibility
- Min Age
- 6 Years
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-11
- Primary Completion
- 2025-08-31
- Completion
- 2025-08-31
Countries
- United States
Study Locations
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