Expired PAR-14-143: Establishing Behavioral and Social Measures for Causal Pathway Research in Dental, Oral and Craniofacial Health (R01)

Part 1. Overview Information

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Dental and Craniofacial Research (NIDCR)
Funding Opportunity Title	Establishing Behavioral and Social Measures for Causal Pathway Research in Dental, Oral and Craniofacial Health (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. May 16, 2014 - See Notice NOT-DE-14-004. Notice of Change in Expiration Date.
Funding Opportunity Announcement (FOA) Number	PAR-14-143
Companion Funding Opportunity	PAR-14-144, R21 Exploratory/Developmental Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.121
Funding Opportunity Purpose	The purpose of this funding opportunity announcement is to encourage the establishment of measures of specific behavioral or social phenomena that can be used to test causal hypotheses about behavioral and social contributors to dental, oral or craniofacial diseases. This announcement encourages the development and testing--or the adaptation and testing--of two types of measures: 1) measures of the health behaviors, social interactions, community characteristics, built environments, etc., targeted by behavioral or social interventions to improve oral health; and/or 2) measures of the hypothesized moderators and mediators of a behavioral or social intervention's effect. Regardless of the type of measure being developed, applications should establish reliability and validity of the measure, and demonstrate acceptability of using the measure with the target population. Note that this announcement does not support the conduct of clinical trials, consistent with the NIDCR policy for acceptance, peer review, and funding of clinical trials (see NOT-DE-11-002).

Key Dates

Posted Date	March 5, 2014
Open Date (Earliest Submission Date)	May 5, 2014
Letter of Intent Due Date(s)	30 days before the application due date
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Standard AIDS dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	(Now Expiring May 8, 2017 per NOT-DE-14-004), Originally September 8, 2017
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this funding opportunity announcement is to encourage the establishment of psychometrically-sound measures of specific behavioral or social phenomena that can be used to test causal hypotheses about behavioral and social contributors to dental, oral or craniofacial diseases. Measures can be developed de novo, or adapted from existing measures, e.g., those used in other fields or for different purposes. In either case, applications should include appropriate psychometric tests of the measure(s), and testing for acceptability of use with the target population. This announcement calls for the development of two types of measures: 1) measures of the health behaviors, social interactions, community characteristics, built environments, etc., targeted by behavioral or social interventions to improve oral health; and 2) measures of the hypothesized moderators and mediators of a behavioral or social intervention's effect.

Applications in response to this announcement may not propose to conduct a clinical trial. Since 2008, NIDCR has supported investigator-initiated clinical trials through a two part grant process: (1) a clinical trial planning grant (R34) followed by (2) a clinical trial implementation cooperative agreement (U01). Applications proposing to conduct a clinical trial, regardless of size, must follow the NIDCR policies and procedures for acceptance, peer review, and funding of clinical trials. For more information, please see NOT-DE-11-002.

Background

Researchers in the oral health field have developed strong measures that serve specific purposes, including surveillance, identification of dental disease risk and protective factors, and quantification of patient-reported outcomes. As a result of surveillance efforts, we can identify national trends in oral health status, as well as populations who bear the greatest burden of oral diseases and conditions. Efforts to identify behavioral or social factors that increase or decrease risk of oral disease have produced measures useful in assessing risk for certain oral diseases, e.g., measures to screen for tobacco use as one indicator of periodontal disease risk. Efforts to capture aspects of oral health most important to patients--typically called "Patient-Reported Outcomes" or PROs--have yielded measures often used along-side clinical measures as outcomes of clinical trials.

As oral health researchers move from hypothesis-generating research to hypothesis-testing research, they need measures and tools that allow for rigorous tests of those hypotheses. Most of the existing oral health measures were designed for purposes other than testing causal models of oral health behavior. For instance, a well-designed risk assessment measure typically sacrifices specificity for sensitivity, over-identifying those who may be at-risk for disease. While this risk assessment serves the purpose of identifying those who may benefit from a thorough follow-up clinical evaluation, it is not precise enough to quantify risk factors to test in a causal model. Similarly, patient-reported outcomes reflect general constructs, such as quality of life and perceived functional impairment, but do not offer the specificity often needed to test hypotheses about the causal pathway to favorable outcomes.

Scope of Funding Opportunity

For the purposes of this announcement, two types of measures are encouraged. Below is a brief description of each, along with example topics:

1) This announcement invites applications that develop/adapt and test measures of the targets of behavioral and social interventions to improve dental, oral and craniofacial health.

A broad range of intervention targets are appropriate, including, but not limited to:

Individual behavior (e.g., at-home oral hygiene);
Dyadic communication (e.g., hygienist-patient visits in the dental clinic);
Family relationships (e.g., social supports for families with ECC at-risk children);
Communities (e.g., engaging peer advocates to connect people with dental services);
Schools (e.g., nutrition programs to de-emphasize sugary beverages);
Workplaces (e.g., integrated tobacco cessation programs);
Health care organizations (e.g., elevating prevention approaches to "standard of care");

Measures capturing any of a broad range of health behaviors relevant to dental, oral or craniofacial interventions are appropriate for this announcement. These measures include, but are not limited to:

Techniques to accurately assess the frequency and quality of tooth brushing that do not require daily, in-person visual inspection by a dental care provider;
Measures that accurately reflect the frequency and quality of eating and drinking behavior related to oral and dental health;
Approaches to assessing oral health communication between two or more people (e.g., peer advocates and community members, caregivers and children, providers and patients, teachers/instructors and students, providers and individuals with special needs, etc.);
Instruments or processes that describe novel targets of behavioral interventions (e.g., social network connectivity);
Measures adapted from other fields to be applied to oral health behaviors (e.g., delayed discounting, psychotherapy process measures);
Measures that make use of emerging technologies to record and accumulate real-time behavioral data (e.g., mobile/mHealth technologies, wearable biosensors, actigraphy, geospatial mapping).

2) This announcement also encourages the development or adaptation of, and subsequent testing of, measures of potential moderators and mediators of behavioral and social intervention effects. Behavioral and social factors contribute to oral health in many different ways. The statistical terms moderator and mediator allow investigators to make and test hypotheses about the nature of those contributions. For the purpose of this announcement, we subscribe to the definitions of these terms offered by MacKinnon and Luecken (2011), in an NIDCR-supported special issue of the Journal of Public Health Dentistry focused on behavioral and social intervention research. In sum, a moderator is a variable for which the relationship between two other variables differs at different values of the moderator. Importantly, a moderator is not an intermediate step between independent variable (IV) and dependent variable (DV) in a causal chain, but rather precedes the IV in a causal model. A classic example of a moderator could be sex/gender, if men and women were found to respond differently to a behavioral intervention. In contrast, a mediator is an intermediate step in the causal chain between the IV and the DV, such that the IV is thought to affect the DV by the IV's effect on the mediator. An example of a mediator could be tooth brushing skills, if an intervention aimed at improving oral hygiene is found to improve oral hygiene by improving tooth brushing skills.

Strong measures of potential moderators and mediators of the effects of behavioral and social interventions are already available in the published literature. However, many measures seem to have limited utility in contributing to causal explanations of health behaviors. Some measures may specify multi-dimensional constructs as uni-dimensional, such as the constructs of motivation and oral health literacy. Other measures may have unacknowledged conceptual overlap with one another, such as self-efficacy, sense of control, and self-esteem. Still other measures may conflate clinical symptoms with clinical syndromes or diagnoses, such as psychological distress and diagnosed affective disorders. Certain measures may be used for purposes beyond their capabilities, such as detecting change over time, or identifying rare cases. This announcement encourages the development or adaptation of, and subsequent testing of, measures of potential moderators and mediators of behavioral and social intervention effects. Examples of appropriate projects include, but are not limited to:

Development and testing of a valid and reliable instrument that disaggregates a multi-dimensional construct into one or more meaningful components;
Adaptation of a moderator or mediator measure found to be important in another field, tested and refined for use in oral health behavioral research;
Testing and/or comparison of existing measure(s) to establish the conditions for their utility
Development and testing of a psychometrically-sound measure of an established moderator or mediator, using novel methods (e.g., methods that give more accurate estimates, methods that are more sustainable, methods that can be disseminated more widely);
Development and testing of a psychometrically-sound measure of a novel moderator or mediator.

Whether focusing on measuring a target of a behavioral intervention, or a potential moderator or mediator of an intervention’s effect, applicants are expected to establish reliability and validity of the measure, and to demonstrate acceptability of using the measure with the target population. Among other considerations, the mode of delivery, response options, phrasing and ordering of questions or prompts may all influence the validity of a measure. Individual differences including language fluency, education level, cultural identity, disease status and life experiences may all influence how research participants understand measures and report behavior. No particular methodology is required or preferred in response to this announcement; the goals of the research should drive the methods selected. That said, the NIDCR supported a web-based workshop series on survey research methods that applicants may find helpful in guiding applications in response to this announcement. Please see the NIDCR website for access to narrated slide presentations and written transcripts of the presentations.

Section II. Award Information

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Renewal Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period	The total project period for an application submitted in response to this funding opportunity announcement may not exceed 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession

Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed activity
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
Names of other key personnel
Participating institution(s)
Number and title of this funding opportunity

The letter of intent should be sent to:

Weijia Ni, PhD
Chief, Risk, Prevention, and Health Behavior IRG
CSR, NIH
Telephone: 301-594-3292
Fax: 301-435-0014
Email: niw@csr.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover