Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Mental Health (NIMH)

Funding Opportunity Title

Improving Health and Reducing  Cardiometabolic Risk in Youth with Serious Emotional Disturbance and Young Adults with Severe Mental Illness (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-MH-16-600

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.242 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) aims to support research grants focused on rigorous effectiveness testing of innovative services interventions that demonstrably reduce the prevalence and magnitude of common health risk factors related to shortened lifespan in youth with serious emotional disturbance (SED) and young adults with severe mental illness. These risk factors include, but are not limited to, smoking, obesity, hypertension, dyslipidemia, low physical activity, substance use, poor fitness and diet. This FOA aims to generate the service delivery knowledge necessary to achieve 100% screening of this population for common, cardiometabolic risks and 100% referral to appropriate care to manage the identified risks. This FOA aims to support population-based approaches to prevention, identification and intervention, i.e., targeting cardiometabolic risk in entire populations of youth with SED and/or young adults with SMI within a given community or healthcare setting.

Key Dates
Posted Date

August 12, 2015

Open Date (Earliest Submission Date)

October 6, 2015

Letter of Intent Due Date(s)

October 6, 2015

Application Due Date(s)

November 6, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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)

Not Applicable

Scientific Merit Review

February/March 2016

Advisory Council Review

May 2016

Earliest Start Date

July 2016

Expiration Date

November 7, 2015

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

This Funding Opportunity Announcement (FOA) aims to support research grants focused on rigorous effectiveness testing of innovative services interventions that demonstrably reduce the prevalence and magnitude of common health risk factors related to shortened lifespan in youth with serious emotional disturbance and young adults with severe mental illness. These risk factors include, but are not limited to, smoking, obesity, hypertension, dyslipidemia, low physical activity, substance use, poor fitness and diet. This FOA aims to generate the service delivery knowledge necessary to achieve 100% screening of this population for common, cardiometabolic risks and 100% referral to appropriate care to manage the identified risks. This FOA aims to support population-based approaches to prevention, identification and intervention, i.e., targeting cardiometabolic risk in entire populations of youth with SED and/or young adults with SMI within a given community or healthcare setting.

Background

People with severe mental illness (SMI) die from the same causes of death that affect the general population, e.g., heart disease, diabetes, cancer, stroke, and pulmonary disease, but at a more rapid rate. Specifically, adults with psychotic disorders die an average of 11 years earlier than do adults with no mental disorder, most often from these co-morbid medical conditions. The cardiometabolic health risk factors that contribute to early mortality—smoking, obesity, hypertension, dyslipidemia, low physical activity, substance use, poor fitness and diet—are also more common in people with SMI and their onset is often earlier. Two-thirds or more of adults with SMI smoke; over 40% are obese; and metabolic syndrome is highly prevalent (43%), especially in women (54%). Iatrogenic effects of psychiatric medications, which may include weight gain and metabolic disorder, further adversely affect the health of people with SMI, often with rapid onset. The 11.4 million adults with SMI in the U.S. are disproportionately affected by these conditions, and low rates of prevention, detection, and treatment result in substantial disease burden and premature mortality.

The initial occurrence and early progression of cardiometabolic health risk factors associated with premature mortality in people with SMI are poorly understood, but evidence suggests that these risks appear early and typically go untreated. Recent research suggests that children and adolescents with SED are at higher risk than adults for developing metabolic abnormalities and may be especially vulnerable to the adverse metabolic effects of psychiatric medications given their developing bodies and brains. The number of children and adolescents prescribed psychiatric medications—for both off-label and FDA-approved uses—is growing, which may increase the number of young people who develop modifiable health risk factors. These findings point to the need to intervene early to reduce and/or prevent elevated cardiometabolic risk in youth with serious emotional disturbance (SED) and young adults with SMI.

Unfortunately, youth and young adults prescribed psychotropic medications are seldom screened for cardiometabolic risk factors, which go undetected and may amplify over time. Effective interventions to prevent and/or reduce these health risks exist for the general population, but they are generally unavailable to youth with SED and young adults with SMI. Furthermore, the impact of these interventions and the degree of adaptation needed for effectiveness in youth with SED and young people with SMI, who may experience cognitive impairment, motivational deficits, challenges in functioning, social isolation, few resources and limited access to healthcare, remain unknown. Two serious knowledge gaps need to be addressed: How to (1) identify cardiometabolic risk at the earliest possible opportunity in youth with SED and young adults with SMI and (2) deliver to these populations those strategies proven effective in the general population to prevent or reduce modifiable cardiometabolic risk factors associated with premature mortality.

Research Objectives

The goal of this FOA is to support research designed to develop and test the effectiveness of services interventions that aim to reduce the prevalence and magnitude of common, modifiable cardiometabolic risk factors that contribute to premature mortality in youth with SED and young adults with SMI. This FOA aims to generate the service delivery knowledge necessary to achieve 100% screening of this population for common, modifiable cardiometabolic risks and 100% referral to appropriate care to manage the identified risks. This FOA aims to support population-based approaches to prevention, identification and intervention, i.e., targeting cardiometabolic risk in entire populations of youth with SED and/or young adults with SMI within a given community or healthcare setting.

For purposes of this FOA, NIMH defines “severe mental illness” or SMI and “serious emotional disturbance” or SED as a diagnosable psychiatric disorder that results in functional impairment which substantially interferes with or limits major life activities. The criteria for inclusion as an SMI or SED relate to the severity of the psychiatric disorder causing significant impairment rather than to a specific diagnostic category, per se. For purposes of this FOA, “youth” are defined as individuals 5-18 years of age and "young adults" as 19-30 years.

The proposed services intervention must include youth with SED and/or young adults with SMI and specifically target one or more modifiable cardiometabolic risk factors that have been linked to premature mortality in people with SMI. Ideally, the services intervention will have the following features:

  • has demonstrated the clinical effectiveness of the intervention's core components in the general population (although adaptation may be needed for equivalent effectiveness in youth with SED or young adults with SMI);
  • has relevance to the life circumstances of youth with SED or young adults with SMI;
  • will be conducted in a community-based setting that serves as a platform to engage this population (either within or outside of traditional healthcare settings);
  • has the potential to produce clinically (not just statistically) significant health improvement and reduction in common modifiable health risk factors associated with early mortality in people with SMI;
  • will target all youth with SED or young adults with SMI in a given setting, community or care delivery system;
  • has a high likelihood for real-world feasibility in terms of required resources, staffing, training, and patient acceptability;
  • has strong potential to be expanded easily to many settings, so as to reach a large portion of at-risk youth with SED or young adults with SMI, should the services intervention prove clinically effective with this population.

This FOA is intended to support effectiveness trials that not only test the effects of the services intervention on cardiometabolic risk reduction outcomes, but also explicitly inform understanding of whether the services intervention engages the target(s)/change mechanism(s) presumed to underlie risk reduction processes (see NIMH web page on Clinical Trials). Thus, the results of the effectiveness trial will advance knowledge regarding putative change mechanisms as well as relationships among change mechanisms and intervention outcomes.  

A variety of rigorous methodological approaches are possible for testing the impact of the services intervention. These approaches include randomized controlled trials, quasi-experimental designs with non-randomized comparison groups, time series designs, and other designs of equivalent rigor and relevance. Considerations for selecting a research design for the proposed effectiveness study include the scientific question that the study is designed to answer, practical constraints, ethical issues, and the tradeoff between maximizing internal and external validity.

When possible, studies should capitalize on existing infrastructure, (e.g., practice-based research networks such as the NIMH-sponsored Mental Health Research Network [MHRN], electronic medical records, administrative databases, and patient registries) to increase the efficiency of recruiting participants (i.e., more rapid identification and enrollment) and facilitating the collection of moderator data (e.g., clinical characteristics, biomarkers) and longer-term follow-up data. 

NIMH encourages studies that can contribute to advancing the personalization of mental health care and include collection of clinical and biological variables (e.g., blood for genetic analysis, other potential biomarkers), as appropriate, that might be used to inform or test algorithms for more prescriptive approaches and contribute information to larger databases for future use.

NIMH also encourages research that takes into account RDoC or RDoC-like constructs when defining the subject eligibility (inclusion), intervention targets or mechanisms, and outcomes, as appropriate and feasible (see the RDoC webpage for more details).

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

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIMH intends to commit $2.4 million in FY 2016 to fund up to 5 awards.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 5 years; however, applicants are strongly encouraged to limit their proposed project period to 3 or 4 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
Foreign Institutions

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 not 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.
  • 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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
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, including Supplemental Grant Application Instructions 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:

NIMHReferral@mail.nih.gov

Page Limitations

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

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

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Facilities and Other Resources:   The description of the resources and environment should address how the study utilizes existing infrastructure (e.g., CTSAs, practice-based research networks, electronic medical records, administrative data bases, patient registries) or utilizes other available resources to increase the efficiency of participant recruitment and data collection or provide a justification in the event that such efficiencies cannot be incorporated. In addition, as applicable, applicants should describe how the proposed services intervention capitalizes on a real-world setting that is already engaging youth with SED or young adults with SMI.

Other Attachments:  Applicants should upload a single attachment that includes the following information relevant to the proposed clinical trial. Applicants should use the headers below in their description. This attachment must be no more than 4 pages.  Applications that exceed this limit will not be reviewed.

I.  Participant Recruitment and Retention Procedures:  Applications must provide a clear description of:

  • Recruitment and Referral sources, including detailed descriptions of the census/rate of new cases and anticipated yield of eligible participants from each source;
  • Procedures that will be used to monitor enrollment and track/retain participants for follow-up assessments;
  • Strategies that will be used to ensure a diverse, representative sample;
  • Potential recruitment/enrollment challenges and strategies that can be implemented in the event of enrollment shortfalls (e.g., additional outreach procedures, alternate/back-up referral sources);
  • Evidence to support the feasibility of enrollment, including descriptions of prior experiences and yield from research efforts employing similar referral sources and/or strategies.

II. Study Milestones and Timeline:  Applications must provide a clear description of:

  • Objective, quantifiable, and scientifically justified study milestones; and
  • A proposed timeline for reaching important study milestones such as: (a) finalizing the study  procedures and training participating clinical site staff; (b) finalizing the intervention manual and assessment protocols, including fidelity measures/procedures, where applicable; (c) enrolling 25%, 50%, 75% and 100% of the sample; (d) completing all subject follow-up assessments and data collection activities, including data quality checks; (e) analyzing and interpreting results; and (f) preparing de-identified data and relevant documentation to facilitate data sharing, as appropriate. 
  • The proposed milestones should describe projected specific, measureable and achievable progress throughout the project period, which can be used as an indicator of success.
SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.  In addition, the Biosketches of the PD/PI and other senior investigators should reflect qualifications and expertise in the following areas:

  • Implementing health promotion or risk reduction programs for youth with SED or young adults with SMI,
  • Conducting large-scale practical tests of health promotion or risk reduction services interventions in real-world settings,
  • Recruiting and retaining youth with SED or young adults with SMI in large-scale studies, and
  • Assessing common modifiable cardiometabolic risk factors.
R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

Research Strategy: Applicants must include the following information as part of the Research Strategy. Applications should not duplicate information provided in the Other Attachment included in the SF424 (R&R) Other Project Information form unless needed to provide context.

The Significance section of the application should include the following information:

  • Provide evidence supporting the potential of the proposed services intervention to produce clinically meaningful (versus only statistically significant) reductions in common, modifiable cardiometabolic risk factors associated with premature mortality in the target population of youth with SED or young adults with SMI.
  • Explain how the proposed services intervention is designed to support broad dissemination and implementation in real-world settings should it prove effective. 
  • Describe how the application addresses a critical question related to (1) adapting evidence-based cardiometabolic risk reduction interventions to achieve clinically significant effectiveness in youth with SED or young adults with SMI, or (2) increasing capacity to deliver health risk reduction interventions to these populations.
  • If the services intervention targets multiple cardiometabolic risk factors, describe how the multiple intervention components are integrated.  

The Innovation section of the application should include the following information, as applicable for the proposed project:

  • Explain how the proposed services intervention uses novel means to increase the intervention's effectiveness, efficiency or reach to youth with SED or young adults with SMI.

The Approach section of the application should include the following information:

  • Detail the plan to explicitly address how the services intervention engages mechanisms that are presumed to underlie the services intervention effects (i.e., the mechanisms that account for changes in cardiometabolic risk reduction as a result of population-level interventions involving risk screening and initiation of and engagement in interventions to prevent and manage cardiometabolic risk). Include the following: 

 (1) a conceptual framework that clearly identifies the target(s)/mechanism(s) related to risk reduction processes and the empirical evidence linking the target(s)/mechanism(s) to the cardiometabolic risk factors that the intervention seeks to improve;

 (2) plans for assessing engagement of the target(s)/mechanism(s) using valid measures that are as direct and objective as is feasible in the effectiveness context, including the specific measures, the assessment schedule, and the justification for the assessment strategy (e.g., evidence regarding the validity and feasibility of the proposed measures in the effectiveness context); and

 (3) an analytic strategy and corresponding power calculations for data analyses that will be used to examine whether the services intervention engages the target(s) and whether intervention-induced changes in the target(s) are associated with cardiometabolic risk reduction (i.e., mediation). In the case of multi-component interventions, the application should specify the conceptual basis, assessment plan, and analytic strategy, as detailed above, for the target(s)/mechanism(s) corresponding to each intervention component, as appropriate in the effectiveness context.

  • Explain how the selected research methods minimize confounds that may limit the ability to infer causality.
  • Describe how the trial design and description of the research protocol are consistent with CONSORT guidelines, as appropriate.
  • Detail the assessment of clinically significant patient-level outcomes that represent objective indicators of health improvement and cardiometabolic risk reduction, e.g., improved glycemic levels, improved lipid levels, lowered cholesterol levels, healthier body mass index, and lowered blood pressure.
  • Where appropriate, describe how racial, ethnic, or gender disparities in the receipt of or response to cardiometabolic risk reduction interventions among youth with SED and young adults with SMI are addressed.
  • When appropriate, detail how the study takes into account RDoC or RDoC-like constructs when defining the subject eligibility (inclusion), intervention targets or mechanisms, and outcomes, as feasible in the effectiveness setting.
  • Describe provisions for the assessment and monitoring of the fidelity of intervention delivery via procedures that are feasible and valid for use in community practice settings.
  • As appropriate, describe plans to involve collaborations and/or input from community practice partners/providers, consumers, and relevant policy makers in a manner that informs the research and helps to ensure the results will have utility.
  • As relevant, address how the trial contributes to advancing the personalization of care and describe the collection of clinical and biological variables (e.g., blood for genetic analysis, other potential biomarkers) that might be used to examine moderators or inform/test algorithms for more prescriptive approaches. Address statistical power to test for moderators and/or the potential to contribute information regarding potential moderators to larger databases for future use.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

In order to advance the goal of widespread data sharing among researchers, investigators funded under this FOA are expected to share those data via the National Database for Clinical Trials related to Mental Illness (NDCT; http://ndct.nimh.nih.gov/; see NOT-MH-14-015 and NOT-MH-15-012). Established by the NIH, NDCT is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDCT links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this FOA are expected to use these technologies to submit data to NDCT.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDCT web site provides two tools to help investigators develop appropriate strategies: 1) the NDCT Budgeting Spreadsheet http://ndct.nimh.nih.gov/preplanning/budget - a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent http://ndct.nimh.nih.gov/preplanning/informed-consent. Investigators are expected to certify the quality of all data generated by grants funded under this FOA prior to submission to NDCT and review their data for accuracy after submission. Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see Data Sharing Expectation http://ndct.nimh.nih.gov/preplanning/#tab-1 for more information); Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied by using the Study functionality(see http://ndct.nimh.nih.gov/results). The NDCT Data Sharing Plan is available for review on the NDCT web site (http://ndct.nimh.nih.gov/wp-content/uploads/NDCT_Data_Sharing_Policy_20141002.pdf ). NDCT staff will work with investigators to help them submit data types not yet defined in the NDCT Data Dictionary http://ndct.nimh.nih.gov/submit/data-dictionary.

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the NIMH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at NIMHReferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Is evidence provided that supports the potential of the proposed services intervention to produce clinically meaningful (versus only statistically significant) reductions in common, modifiable cardiometabolic risk factors associated with premature mortality in the target population of youth with SED or young adults with SMI?

Is the proposed services intervention designed to support broad dissemination and implementation in real-world settings should it prove effective? 

Does the application address a critical question related to (1) adapting evidence-based cardiometabolic risk reduction interventions to achieve clinically significant effectiveness in youth with SED or young adults with SMI, or (2) increasing capacity to deliver health risk reduction interventions to these populations?

If the services intervention targets multiple cardiometabolic risk factors, does it integrate the multiple intervention components?   

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 

Do the qualifications of the PD/PI and other senior investigators include adequate expertise in one or more of the following areas:

  • Implementing health promotion or risk reduction programs for youth with SED or young adults with SMI;
  • Conducting large-scale practical tests of health promotion or risk reduction services interventions in real-world settings;
  • Recruiting and retaining youth with SED or young adults with SMI in large-scale studies; and
  • Assessing common modifiable cardiometabolic risk factors?
Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? 

Does the proposed services intervention use novel means to increase the intervention's effectiveness, efficiency or reach to youth with SED or young adults with SMI?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

Where applicable, do the chosen outcome variables represent relevant and objective measures of cardiometabolic risk reduction, such as improved glycemic levels, improved lipid levels, lowered cholesterol levels, healthier body mass index, or lowered blood pressure?

Where applicable, does the application adequately address racial, ethnic, or gender disparities in the receipt of or response to cardiometabolic risk reduction interventions among youth with SED and young adults with SMI?

Has the applicant explained how the selected research methods minimize confounds that may limit the ability to infer causality?

Is the study designed to explicitly address whether the services intervention engages the mechanism that is presumed to underlie the services intervention effects (i.e., the mechanisms that account for changes in cardiometabolic risk reduction)? Does the application include the following:

 (1) a well-supported conceptual framework that clearly identifies the target(s)/mechanism(s) and the empirical evidence linking the target(s)/mechanism(s) to the cardiometabolic risk(s) that the intervention seeks to improve;

 (2) well-justified plans for assessing engagement of the target(s)/mechanism(s), including the specific measures, the assessment schedule, and the justification for the assessment strategy (e.g., evidence regarding the validity and feasibility of the proposed measures in the effectiveness context); and

 (3) an appropriate analytic strategy and corresponding power calculations for data analyses that will be used to examine whether the services intervention engages the target(s) and whether intervention-induced changes in the target(s) are associated with reduction in cardiometabolic risk (i.e., mediation)?

Is the study sufficiently powered to examine mediators of intervention effects? In the case of multi-component services interventions, does the application specify the conceptual basis, assessment plan, and analytic strategy, as detailed above, for the target(s)/mechanism(s) corresponding to each intervention component, as appropriate in the effectiveness context?

Does the application include provisions for the assessment and monitoring of the fidelity of intervention delivery via procedures that are feasible and valid for use in community practice settings?

Are the trial design and description of the research protocol consistent with CONSORT guidelines, as appropriate?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the proposed services intervention capitalize on a real-world setting that is already engaging youth with SED or young adults with SMI?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Milestones and Timelines

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessments?  Is the project timeline feasible and well justified? 

Are appropriate, evaluative milestones clearly defined for the aims associated? Are the milestones feasible and quantifiable with regard to the specific aims and timeline?  Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)? 

Does the project incorporate efficiencies and utilize existing resources (e.g. CTSAs, practice-based research networks, electronic medical records, administrative data bases, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? 

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIMH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Susan T. Azrin, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3267
Email: azrinst@mail.nih.gov

Peer Review Contact(s)

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: armstrda@mail.nih.gov

Financial/Grants Management Contact(s)

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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