Notice of Intent to Publish a Funding Opportunity Announcement for Leveraging Extant Data to Understand Developmental Trajectories of Late Talking Children (R21 Clinical Trial Not Allowed)

Key Dates

None

National Institute on Deafness and Other Communication Disorders (NIDCD)

The National Institutes of Health (NIH) Tackling Acquisition of Language in Kids (TALK) initiative seeks to support activities to better understand early language learning and delay. Late talking, also known as late language emergence, is diagnosed when a child, usually over the age of 18 months, is not meeting expressive language milestones. Approximately 10% to 20% of children receive this diagnosis. Children may be at higher risk for late talking for a variety of reasons including, but not limited to, premature birth, exposure to maltreatment or trauma, and intellectual and developmental disorders; and yet other children present as late talkers for no other known reason and with no other symptoms.  NIH TALK intends to publish a notice of funding opportunity (NOFO) to solicit applications for research projects that aim to further our understanding of the developmental trajectories of late talking children by leveraging existing datasets that include late talking children, those at-risk for late talking, or those with a history of late talking. The overall goal of this initiative is to create an open and shared data resource to aid in identifying patterns and predictors of developmental outcomes in late talking children, and exploring potential underlying mechanisms, risk factors, and sequelae. This Notice of Intent to Publish (NOITP) is being provided to allow potential applicants time to explore availability and suitability of extant data resources, and to develop meaningful projects, collaborative research teams, and a Plan for Enhancing Diverse Perspectives  (PEDP). The NOFO is expected to be published in fall 2023 with an expected application due date in winter 2024. The NOFO will use the R21 activity code. Details of the planned NOFO are provided below. 

The goals of this initiative are to spark researchers to create the infrastructure necessary to bring together and make publicly available existing data on different populations of late talking children and to analyze integrated data sets in novel ways to address broader questions about developmental trajectories in late talking children. These goals are to be accomplished through supporting three types of approaches: 1) data sharing: making existing data open and accessible to researchers and the public; 2) secondary data analysis: harmonizing and leveraging existing datasets to address novel questions related to development in late talking children; and 3) data mining: discovery and cataloging of existing datasets that include late talking children. This initial work is intended to create the foundation for future, targeted longitudinal research. Activities that could be supported include, but are not limited to:  

• Creating data sets that can be made available to the general scientific community from restricted access data that cannot be made publicly accessible because they include identifying or sensitive information   
• Creating synthetic data based upon existing data that can be used for modeling purposes  
• Activities for making data ready for secondary analysis. These may include, for example, cleaning or filtering data; imputing missing data, as appropriate; data pre-processing; adoption of ontologies or other standards to improve interoperability with other data  
• Developing and sharing documentation, e.g., metadata that records the provenance, motivation, composition, collection process, recommended uses, and other relevant information for re-users of the data  
• Re-consenting participants in order for data to be made available  
• Harmonizing data and measures across multiple data sets, e.g., integrative data analysis 
• Integrating cross-sectional datasets to provide insights to developmental trajectories  
• Exploring patterns in electronic health records  
• Transcribing existing language samples   
• Conducting more detailed coding of existing audio or videorecorded samples  
• Discovery and cataloging of extant datasets. Note: Data mining activities alone are not sufficient and must be complemented with sharing and/or analytic activities.  

These activities may overlap, and it would be possible for a project to include multiple aspects of the above listed. Types of data of interest include, but are not limited to: administrative data (e.g., electronic health records), survey data, results of assays conducted on biospecimens, data from clinical trials, data from patient registries, and imaging data. Projects that include data from  nih-designated populations that experience health disparities and those that include longitudinal data are especially welcome.  

Resources developed through funded projects, inclusive of datasets and related metadata as well as algorithms and other code used for any data cleaning, recoding, harmonizing and analyses, are expected to be made publicly available in line the NIH Data Management and Sharing (DMS) Policy. Efforts are expected to be informed by best practices in data management and engagement with the language and developmental sciences communities. Proposed activities must protect and maintain confidentiality for research subjects and must include all protections outlined in subject or patient consent forms, if any. 

The following activities will be considered non-responsive for this opportunity and will not be reviewed:  

• Projects that propose studies on populations other than late talking children, those at-risk for late talking, or those with a history of late talking  
• Projects that do not propose data mining, data sharing, and/or secondary data analysis of data sets that include late talking children  
• Projects that only propose data mining with no data sharing and/or secondary data analysis component  
• Projects that propose archiving of data to meet the data sharing requirement for grant applications submitted to NIH for the January 25, 2023 and subsequent receipt dates  
• Projects proposing de novo data collection  
• Projects that do not clearly address how the proposed activities will advance research on and understanding of development in children identified as late talkers  
• Projects classified as clinical trials  
• Projects that fail to include a plan for enhancing diverse perspectives  

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Holly L. Storkel, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: (301) 496-5061 
Email: holly.storkel@nih.gov