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Interagency Autism Coordinating Committee (IACC)
Autism Research Database
Office of Autism Research Coordination (OARC)
 
Project Element Element Description

Project Title

Project Title

Consortium on Biomarker and Outcome Measures of Social Impairment for Use in Clinical Trials in Autism Spectrum Disorder

Principal Investigator

Principal Investigator

Freire, Maria

Description

Description

The consortium seeks to achieve the following specific aims: Aim 1: Compare whether laboratory based (LB) measures versus clinician and caregiver assessments of specific domains of social impairment are more sensitive indicators of (i.e., more strongly correlated with) clinical status. Correlations among the LB measures and clinician and caregiver assessments will also be examined at each time point and across time points. Aim 2: Evaluate whether a well-justified set of ET and EEG measures, individually or in combination, has potential utility as stratification biomarkers and/or sensitive and reliable measures of change in clinical trials. Specifically, we will assess the technical and biological variability of the biomarkers and their relationship with measures of social impairment in order to evaluate the viability of biomarkers in terms of: a. Construct validity demonstrated by task-specific brain activation and signal strength (i.e., modulation of EEG spectral power and event-related potential (ERP) latency/amplitude in accordance with experimental manipulation).
b. Test-retest reliability, consistency, and stability in the sample overall and separately by site and diagnostic group; this will demonstrate that measurements of the potential biomarkers are replicable within subjects, are robust to practice effects, remain stable when underlying clinical status is unchanged, and can be consistently measured across experimental locations and time points, making them suitable for use in multi-site longitudinal clinical trials. c. Discriminant validity reflected in sensitivity to detect differences between ASD and TD subjects’ performance on the measures at each time point and across time points.
d. Convergent validity shown by reliable correlation (i.e., consistent patterns of inter-subject variability) of EEG and ET measures with social-communicative impairment (as assessed by LB and clinician/caregiver assessments) and clinical status (as assessed by independent rater) at each time point. e. Sensitivity to change, assessed in terms of how change in EEG and ET measures corresponds to intra-subject natural course variability in social-communicative impairment and clinical status across time points. Aim 3: Collect blood (DNA) samples from all subjects, including parents of ASD subjects, for future genomic analyses and share raw, processed, and analyzed data via the NDAR and NIH/NIMH Data Repositories to create a community resource accessible for use by all qualified investigators.

Funder

Funder

Simons Foundation

Fiscal Year Funding

Fiscal Year Funding

0

Current Award Period

Current Award Period

2015-2019

Strategic Plan Question

Strategic Plan Question

Question 1: When Should I Be Concerned?

Strategic Plan Objective

Strategic Plan Objective

Green dot: Objective has greater than or equal to the recommended funding. 1LA. Identify behavioral and biological markers that separately, or in combination, accurately identify, before age 2, one or more subtypes of children at risk for developing ASD, and evaluate whether these risk markers or profiles can improve early identification through heightened developmental monitoring and screening by 2014. IACC Recommended Budget: $33,300,000 over 5 years.

Project Link

Project Link

Consortium on Biomarker and Outcome Measures of Social Impairment for Use in Clinical Trials in Autism Spectrum Disorder (External web link)

Institution

Institution

Foundation for the National Institutes of Health

State/Country

State/Country

Maryland

Project Number

Project Number

401674

Federal or Private?

Federal or Private?

Private

Received ARRA Funding?

Received ARRA Funding?

No

History/Related Projects

History/Related Projects

N/A

 
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