Data Acquisition and Analysis Core

Yale University, New Haven CT

Investigators

Linked publications & trials

Abstract

Project Summary/Abstract 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 (a) outcome measures that will be sensitive and reliable assessments of response to treatment and (b) electroencephalography (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 includes five Collaborating Implementation Sites (?Sites?) to 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. The Data Acquisition and Analysis Core (DAAC) will oversee consistent application of scientific standards and methodological rigor for data collection, processing, and analytics. We propose well-justified acquisition standards, many developed by field leaders in this Core, and innovative analytics within an infrastructure designed to facilitate multi-site research. Standard Operating Procedures (SOPs) and Manuals of Procedures (MOPs) will ensure clear, replicable acquisition protocols and post-processing analytic approaches to assess EEG and ET as sensitive indicators of clinical status, as stratification biomarkers for ASD, as sensitive and reliable indicators of change, and in relation to LB- based measures of social-communicative behavior and caregiver/clinician assessments. The DAAC will work together with the Sites and the Data Coordinating Core (DCC) under the oversight of the Admin Core and in coordination with federal and private partners in this collaborative agreement to: 1) design and implement experimental protocols to ensure standardized data acquisition; 2) design and implement rigorous, scientifically valid, and replicable data processing of and artifact removal from data sets; 3) design and implement statistical analyses for biomarker evaluation, including: (a) selecting, implementing, and deriving EEG and ET biomarkers and LB measurement variables with good performance metrics (construct validity, test-retest reliability, stability, and discriminant validity); (b) examining the relationship and sensitivity among EEG and ET biomarkers, LB measures, clinician/caregiver assessments, and independent measures of clinical status; (c) evaluating longitudinal change in ET, EEG, and LB measures to identify if these measures will be sensitive measures for intervention trials.