The goal of this consortium is to establish tools that can be used as biomarkers and/or sensitive and reliable objective assays of social impairment in autism spectrum disorder (ASD) clinical trials. Specifically, we aim to accelerate the development of effective treatments for social impairment in ASD by validating outcome measures that will be sensitive and reliable assessments of response to treatment and EEG and eye-tracking (ET) biomarkers that can be used to reduce heterogeneity of samples via stratification, indicate early efficacy, and/or demonstrate target engagement. The consortium will conduct a naturalistic, longitudinal study of preschool (3-5 years) and school aged (6-11 years) children with ASD and typical development (TD) with IQ ranging from 50- 115. Children will be assessed across three time points (T1: Baseline, T2: 6 weeks, T3: 24 weeks) using clinician, caregiver and lab-based (LB) measures of social impairment, along with a battery of conceptually related EEG and ET tasks and independent ratings of clinical status. This battery measures key facets of social- communication in ASD using well-validated paradigms appropriate for this developmental and cognitive range. Five Collaborating Implementation Sites (?Sites?), all highly experienced in multi-site collaborative clinical research using the methodologies proposed here in both typical and atypical development, will contribute equally to recruitment, screening, diagnosis, testing, and longitudinal assessment. The Data Acquisition and Analysis Core (DAAC) will oversee consistent application of scientific standards and methodological rigor for standardized data collection, processing, and analytics. The Administrative Core will oversee the operations of the Sites, the Data Coordinating Core (DCC), and the DAAC and coordinate with federal and private partners to achieve the aims of this cooperative agreement. The will utilize informatics and technology to develop, maintain, and monitor a robust, secure, HIPAA-compliant data collection, coordination, and storage system to streamline communication and data flow throughout the consortium and ensure organized, secure data management, quality control, and reliable upload to the National Database for Autism Research and NIH/NIMH Data Repositories. The DCC benefits from the Yale Center for Clinical Investigation's quality assurance experience and the existing multi-site ASD research data systems developed by Prometheus Research. The DCC will: 1) Anticipate, respond to, and fulfill the informatics needs of the consortium in the design, harmonization, and implementation of data coordination and innovative data collection methods and tools across the Sites, DAAC, and Admin Core; 2) Provide state-of-the-art methods for: a) consortium communication; b) data management, site monitoring, privacy, and security within the consortium and across Sites; and c) dissemination of information to its stakeholders.
