OpportunityTitle: Consortium on Biomarker and Outcome Measures of Social Impairment for Use in Clinical Trials in Autism Spectrum Disorder (U19)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following:   Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.  Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.  Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Description: The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for the Consortium on Biomarkers and Outcome Measures of Social Impairment in Autism Spectrum Disorder (ASD) in order to generate objective tools for use in clinical trials of behavioral or pharmacologic interventions. The FOA will support a Consortium project to conduct a multi-site study to assess a well-justified set of standardized lab-based measures of domains of social impairment and biological measures (resting state and task-based EEG as well as eye tracking measures) that show promise in school age individuals with ASD at baseline, 6 and 24 week time points. The intent of the FOA is to qualify a set of measures that can be used as stratification biomarkers and/or as sensitive and reliable objective measures of social impairment in ASD clinical trials. A key goal of the Consortium projectis to provide a community resource for broad sharing of all data generated including processed/analyzed data, with rapid and timely deposition of data into the National Database for Autism Research (NDAR). All data generated in this project are expected to be deposited in NDAR and will be accessible for use by all qualified investigators. In addition, blood (DNA) samples are expected to be deposited in the NIMH Repository and Genomics Resource for future research use.The Consortium project will assess the following: (1) whether lab-based measures of specific domains of social impairment in ASD are more sensitive indicators of clinical status compared to commonly used clinician and caregiver assessments of social impairment for their potential use as outcome measures in clinical trials; (2) whether eye-tracking, electrophysiological (EEG) paradigms, or a combination of the two, have potential utility as stratification biomarkers and/or as sensitive and reliable measures of change in ASD clinical trials; (3) the relationship (correlation) of lab-based measures of domains of social impairment to eye tracking or EEG (resting state and task-based) paradigms; and (4) the relationship (correlation) of lab-based measures of domains of social impairment to commonly used clinician and caregiver assessments of social impairment. In addition, the FOA includes a resource aim for the collection of blood (DNA) samples from all subjects, including the parents of ASD subjects, for future genomic analyses.
GrantorContactEmailDescription: If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster
GrantorContactText: NIH OER Webmaster &lt;br/&gt;FBOWebmaster@OD.NIH.GOV &lt;br/&gt;