Autism Biomarkers Consortium for Clinical Trials (ABC-CT)

The Autism Biomarkers Consortium for Clinical Trials (ABC-CT) is a multicenter research study based at Yale that spans Duke University, Boston Children’s Hospital, the University of Washington/Seattle Children’s Research Institute, and the Children’s Hospital of Los Angeles. The aim of the consortium is to develop reliable and objective measurements of social function and communication in autistic people.

Autism is a neurodevelopmental condition that affects social interaction and communication skills and is associated with focused interests and repetitive behaviors. Approximately one percent of children throughout the world are autistic, each with their own unique combination of strengths and weaknesses. It is this extensive “spectrum” of presentations that has proven to be particularly challenging for clinical research.

Currently, autism is diagnosed based on information gathered from clinical assessments and parent questionnaires. ABC-CT will add to this pool of knowledge by developing a more objective battery of tools to measure social function. Using EEG to measure brain function, eye tracking technology to measure visual attention, and automated recording techniques to assess behavior and speech, children aged 6 to 11 will be monitored over a six-month period. In addition to the behavioral measures and biomarker data, this community resource will also include DNA samples from autistic children and their parents for use in future genetic studies.

The consortium will establish a technical and data infrastructure for reliably measuring social function, allowing the collaborating sites to work together as a single unit. The goal is to create a set of measures that can be used in clinical trials to determine which clinical supports are best for which individuals and who will benefit from a particular kind of support. The ultimate goal is to validate a set of tools that will enable clinicians to objectively measure and predict how autistic children would respond to clinical support.

ABC-CT is supported by:

• National Institutes of Health (NIH),
• National Institute of Mental Health (NIMH),
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD),
• National Institute of Neurological Disorders and Stroke (NINDS),
• Foundation for the NIH (FNIH),
• Simons Foundation Autism Research Initiative (SFARI),
• and other partners.

The effort is supported by the FNIH Biomarkers Consortium, a public-private partnership that aims to accelerate biomedical research progress, drawing upon technical input and expert advice from Janssen Research and Development, LLC and the European Autism Interventions-A Multicentre Study for Developing New Medications (EU-AIMS).

The project will be conducted in close collaboration with multiple partners and stakeholders—including SFARI, the U.S. Food and Drug Administration, Janssen Research and Development, LLC, and EU-AIMS—to provide critical input and coordination among public and private sector partners.

The Autism Biomarkers Consortium for Clinical Trials (ABC-CT) is seeking families to participate in a study to improve diagnosis and clinical support for autistic individuals. We are currently recruiting both neurotypical children and children with an autism diagnosis between the ages of 6 and 11 years old.

To learn more about the study or to participate, please call us at 203-737-3439 or email our team at autism@yale.edu.