The goal of this consortium is to establish tools that can be used as biomarkers and/or sensitive and reliableobjective assays of social impairment in autism spectrum disorder (ASD) clinical trials. Specifically, we aim toaccelerate the development of effective treatments for social impairment in ASD by validating (a) outcomemeasures that will be sensitive and reliable assessments of response to treatment and EEG and (b) 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 ofpreschool (3-5 years) and school aged (6-11 years) children with ASD and typical development (TD) with IQranging from 50-115. Children will be assessed across three time points (T1: Baseline, T2: 6 weeks, T3: 24weeks) using clinician, caregiver and lab-based (LB) measures of social impairment, along with a battery ofconceptually related EEG and ET tasks and independent ratings of clinical status. This battery measures keyfacets of social-communication in ASD using well-validated paradigms appropriate for this developmental andcognitive range. Five Collaborating Implementation Sites (“Sites”), all highly experienced in multi-sitecollaborative 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 DataCoordinating Core (DCC) will provide a secure informatics infrastructure to streamline communication and dataflow throughout the consortium to ensure organized, secure data management, quality control, and reliableupload to the National Database for Autism Research and NIH/NIMH Data Repositories. The Data Acquisitionand Analysis Core (DAAC) will oversee consistent application of scientific standards and methodological rigorfor standardized data collection, processing, and analytics. The Administrative Core will oversee the operationsof the Sites, the DCC, and the DAAC to coordinate with federal and private partners in this cooperativeagreement to: 1) Compare whether LB measures versus clinician and caregiver assessments of socialimpairment are more sensitive indicators of clinical status; 2) Evaluate whether this set of ET and EEG measures,individually or in combination, has potential utility as stratification biomarkers and/or sensitive and reliablemeasures of change in clinical trials, assessing viability in terms of: construct validity; test-retest reliability,consistency, and stability; discriminant validity ; convergent validity; and sensitivity to change; 3) Collect blood(DNA) samples from subjects and parents of ASD subjects for future genomic analyses and share raw,processed, and analyzed data to create a community resource accessible for use by all qualified investigators.
Interagency Autism Coordinating Committee (IACC)
Autism Research Database (AFD)
