National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Initiation of a Mental Health Family Navigator Model to Promote Early Access, Engagement and Coordination of Needed Mental Health Services for Children and Adolescents (R01 Clinical Trial Required)
R01 Research Project Grant
Reissue of PAR-17-265
The purpose of this Funding Opportunity Announcement (FOA) is to encourage research applications to develop and test the effectiveness and implementation of family navigator models designed to promote early access, engagement and coordination of mental health treatment and services for children and adolescents who are experiencing early symptoms of mental health problems. For the purposes of this FOA, NIMH defines a family navigator model as a health care professional or paraprofessional whose role is to deploy a set of strategies designed to rapidly engage youth and families in needed treatment and services, work closely with the family and other involved treatment and service providers to optimize care and monitor the trajectory of mental health symptoms and outcomes over time. Applicants are encouraged to develop and test the navigator model’s ability to promote early access, engagement and coordination of mental health treatment and services for children and adolescents as soon as symptoms are detected. Of interest are navigator models that coordinate needed care strategies, determine the “personalized match” to the level of needed service amount, frequency and intensity, and harness novel technologies to track and monitor the trajectory of clinical, functional and behavioral progress toward achieving intended services outcomes.
This FOA is published in parallel to a companion R34 FOA PAR-18-429 supporting pilot studies in preparation for the larger-scale studies described here.
December 5, 2017
January 5, 2018
30 days prior to the application due 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.
January 8, 2021
It is critical that applicants follow the Research (R) 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.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
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
This initiative proposes to develop and test the effectiveness and implementation of a family navigator model, defined as a health care professional or paraprofessional whose role is to deploy a set of strategies designed to rapidly engage youth and families in needed treatment and services, work closely with the family and other involved treatment and service providers to optimize care and monitor the trajectory of mental health symptoms and outcomes over time. Applicants are encouraged to develop and test the navigator model’s ability to promote early access, engagement and coordination of mental health treatment and services for children and adolescents as soon as early symptoms of mental health problems are detected. Of interest are navigator models that coordinate needed care strategies, determine the “personalized match” to the level of needed service amount, frequency and intensity, and harness novel technologies to track and monitor the trajectory of clinical, functional and behavioral progress toward achieving intended services outcomes.
The onset of mental illnesses frequently occurs during childhood or adolescence. Recent national data indicate that nearly half (45%) of youth ages 4-17 with serious emotional and behavioral difficulties do not receive mental health treatment. Among children and adolescents with sub-clinical emotional and behavioral difficulties, parents reported that 80% do not receive needed mental health treatment. Several studies suggest that sub-clinical mental illness symptoms reported in late childhood and early adolescence – if left untreated – are likely to develop into psychological disorders with long-lasting effects well into adulthood.
Traditional mental health services and coordinated care for youth have historically been provided at later points in time, often after mental health symptoms have progressed to clinical levels and have caused significant impairment and distress for the youth and family members. Families attempting to negotiate complex health care referral processes often encounter difficulties accessing and receiving needed mental health services (e.g., youth experiencing symptoms of anxiety, depression or suicidal ideation, yet are not deemed to be at sufficient risk for psychiatric treatment or hospitalization). In addition, many youth and families who experience these problems come from underserved populations and communities and thus are less likely to access or receive needed mental health treatment and services.
Recent research findings and reports suggest that early intervention programs, similar to the Recovery After an Initial Schizophrenia Episode (RAISE) model, are effective at interrupting the developmental trajectory of mental illnesses, and improving clinical and functional outcomes for children and adolescents. In related areas such as Autism Spectrum Disorder, research suggests that early identification and referral to services leads to improved outcomes among young children. Several recent studies testing early intervention programs have reported that variations on the use and type of navigator models across a number of health care fields (e.g., cancer, substance abuse, cardiovascular care) have been found to be effective. Recently completed studies in cancer care reported successful outcomes with a patient navigator model, resulting in increased access, treatment adherence, and compliance with medical instructions. Moreover, multiple studies demonstrated that cancer patient navigator interventions are most effective among patients from minority and underserved populations.
The mental health field has recently initiated the use of navigator models – primarily with adults across a variety of settings. In one model, the navigator consists of a peer-professional working with adults with serious mental illness – and teaching health care self-management, providing treatment monitoring and encouraging follow-up with needed services. Another model utilizes a navigator who is a health care professional with mental health expertise (e.g., case management); the navigator connects the youth and family to treatment and coordinates needed care but does not provide the primary mental health treatment. A third navigator model consists of a navigator who serves as the primary mental health clinician and also provides the care coordination activities.
NIMH is interested in testing the effectiveness and implementation of a navigator model when delivered to children and adolescents as soon as symptoms are detected. Important knowledge gaps include understanding the key attributes of navigator models that: (1) enhance access, engagement and coordination of needed mental health services; (2) contribute to a personalized approach that delivers the appropriate amount, intensity and frequency of needed treatment and services over time; (3) improve clinical, functional and behavioral outcomes for children and adolescents; and (4) reduce disparities in mental health outcomes among underserved populations.
The goal of this FOA is to develop and test navigator models that promote early access, engagement and coordination of mental health treatment and services for children and adolescents who are experiencing early symptoms of mental health problems. This initiative aims to test navigator models that (1) rapidly engage youth and families in needed treatment and services; (2) work closely with the family members and other involved treatment and service providers to optimize care; (3) utilize care coordination strategies and novel technologies to help identify, engage and match youth to mental health treatment and services; and (4) work with youth and families over an extended period of time to ensure that therapeutic gains (e.g., reduction in symptoms, improved family, peer and school functioning and enhanced behavioral outcomes) are maintained.
Navigator models to be tested may include but are not limited to the following: (a) mental health clinicians who provide evidence-based treatment directly to the youth and family and who also monitor the care coordination activities; (b) health care professionals with mental health expertise as the navigator (e.g., nurses, social workers, counselors) who are not responsible for providing the primary mental health treatment, yet are monitoring coordinated care and communication with the other involved treatment and service providers; or (c) paraprofessionals trained in mental health education and in the application of proven engagement approaches (e.g., motivational interviewing) who monitor coordinated care and communication with the other involved treatment and service providers. Each model will develop and test a set of strategies deployed by the navigator designed to promote early access, engagement and coordination of mental health treatment and services.
Please note that applications that propose to test the effectiveness of traditional therapeutic or preventive interventions, rather than testing navigator models that aim to improve access, engagement, and coordination of services and applications that propose testing task-shifting or other approaches to deliver traditional therapeutic/preventive interventions by paraprofessionals or other non-traditional therapists - would be considered outside the scope of this FOA and will not be supported.
Navigator training needs will vary among different models and applicants are encouraged to provide a description of the training required for the proposed model. For example, when the navigator is a mental health professional, training may focus more on care coordination, availability of local resources and utilization of novel technologies, while navigators who are paraprofessionals may need supplemental training on mental health symptoms and treatment, family dynamics and the principles of engagement. All models should consider the need for ongoing supervision of or consultation with the navigator to achieve fidelity and sustainability of the model. Applicants are also encouraged to provide justification of both the likelihood of achieving the intended outcomes and the potential for broad uptake and implementation, should a tested model prove to be effective.
Navigator model settings may be located in mental health clinics, public health agencies (e.g., child welfare and juvenile justice), schools, primary care or other settings. Navigators should work closely and be integrated with other treatment and service providers to facilitate and monitor routine communication to the treatment providers, youth and family members. It is anticipated that referrals to a navigator may occur through a range of referral sources (e.g., caregiver, teacher, healthcare provider), depending on the navigator model, and can occur before a formal mental health assessment or screening takes place. Navigator functions should include one or more of the following attributes: (a) overcoming systemic barriers to care (e.g., coordination of screening, diagnosis and ongoing care from a range of treatment providers); (b) delivering mental health information, education and psychosocial support to caregivers and youth; (c) utilizing engagement strategies to increase treatment adherence; and (d) problem-solving resource challenges (e.g., healthcare coverage, literacy, transportation, childcare).
This FOA is intended to support applications that test personalized navigation approaches that deliver the appropriate amount, intensity and frequency of needed treatment and services as symptoms wax and wane over time. NIMH encourages research that utilizes novel technology (e.g., dashboards, outcome tracking, and therapeutic milestone measurement) to assist navigators in facilitating and optimizing personalized mental health care for each child and adolescent. When possible, applications should incorporate health information technology (HIT) and electronic health records (EHR) to coordinate care across delivery settings.
Applications must identify the variables (intervention targets) hypothesized to lead to the intended outcomes of the proposed navigator model, measure whether those variables are engaged during the navigator intervention delivery, and design the study to test whether target engagement mediates the outcome of the navigator intervention. Active elements of the model might occur at the navigator, treatment team (involved treatment and service providers), supervisor, interagency and/or community level, and appropriate studies should clearly describe and include such factors in the conceptualization of the intervention and in the design of the study. For more information about measurement of target engagement, see: Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01).
A variety of rigorous methodological approaches are possible for testing the impact of the proposed navigator model. These approaches may 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 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.
Applicants are strongly encouraged to propose a navigator model that identifies factors that facilitate sustainability (e.g., shared public and private funding, utilization of existing personnel or realignment of responsibilities to include the navigator role, effective economic strategies), scalability and generalizability to other settings. NIMH anticipates that studies funded by this FOA will substantially contribute to the development of the following: a body of generalizable knowledge regarding effective mental health navigation models; identification of a set of research-informed strategies to improve care coordination; the use of novel technology to match youth with appropriate treatment and services; and generation of new knowledge regarding the impact of navigator models on reducing or eliminating mental health disparities among underserved populations.
This FOA is intended to support studies that are statistically powered to provide a definitive test of the navigator model’s effectiveness in comparison to usual care practices or alternative intervention/services approaches. Support for pilot studies to promote the development of and evaluate the initial feasibility, acceptability, and preliminary effectiveness of navigator models is provided via PAR-18-429 (Pilot Studies to Test the Initiation of a Mental Health Family Navigator Model to Promote Early Access, Engagement and Coordination of Needed Mental Health Services for Children and Adolescents (R34) and its reissues.
Potential applicants are strongly encouraged to contact Scientific/Research contacts as far in advance as possible to discuss the match between potential research applications and current NIMH priorities.
Protections for Human Subjects: Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly. The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-15-025). The application’s Protection of Human Subjects section plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Required: Only accepting applications that propose clinical trial(s)
NIMH intends to commit approximately $2,160,000 in FY2018 to fund between 5-6 grants submitted to this FOA and to the companion FOA.
Application budgets are limited to $500,000 direct costs per budget year and should reflect the actual needs of the proposed project
The maximum project period is 5 years; however, applicants are encouraged to limit the proposed project period to 4 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
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.
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.
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.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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:
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the Research (R) 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.
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:
The letter of intent should be sent to:
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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 whether and how the study utilizes existing infrastructure (e.g., Clinical and Translational Science Awards (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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Applications should include the following:
Describe the potential public health impact of the proposed strategy, in terms of the implications of
the initiation of a navigator model to promote early access to, engagement in and coordination of needed mental health care and services among children and adolescents.
Describe how the proposed research would contribute to a body of generalizable knowledge regarding how effective navigator models may optimize the delivery of mental health services, improve care coordination strategies and improve the ‘personalized match’ with appropriate treatment and services (e.g., under what conditions might navigators serve as reliable and valid informants for determining the needed amount, frequency and intensity of mental health services) to ensure that therapeutic gains are maintained over time.
Identify how the proposed project will facilitate sustainability, scalability and enhance the navigator model’s potential for implementation and future uptake in diverse settings.
As applicable, describe how the navigator model may reduce or eliminate racial, ethnic, gender or socio-economic disparities in the delivery of services and interventions.
Describe any innovations in navigator model development, feasibility testing, research strategy, design or analytic approach, if they are employed, and how these may enhance the potential value of study results.
Describe the use of innovative technologies (e.g., use of dashboards, outcome tracking, and therapeutic milestone measurement, incorporation of health information technology) to assist navigator models in delivering personalized mental health care for each child and adolescent.
Identify new approaches to promote early access, engagement and coordination of mental health treatment and services for children and adolescents who are exhibiting early symptoms of mental health problems.
This FOA is intended to explicitly inform our understanding of whether the services intervention engages the target(s)/change mechanism(s) that are presumed to underlie downstream changes in access, engagement and coordination. Accordingly, the application should address: (1) the empirical basis for the selection of the proximal targets/change mechanisms; (2) the approach used for assessing target engagement (specific measures that will be used to assess changes in the putative proximal targets/ change mechanisms); and (3) the analysis plan that will be used to determine whether the intervention leads to changes in the targets/ change mechanisms, and whether changes in these targets account for changes in the services outcomes.
Describe the proposed method for assessing the effectiveness and implementation of a navigator model and specify the research strategies that will be used to measure the active attributes of the navigator model, clinical progress and clinical, functional and behavioral outcomes.
Describe plans to promote long-term sustainability by incorporating stakeholder perspectives to enhance partnerships with public and private agencies, healthcare systems, and community programs.
Describe the steps for navigator model development/refinement and a clear rationale for the choice of methods proposed.
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.
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:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Section 2 - Study Population Characteristics
2.5 Recruitment and Retention Plan
Applications must provide a clear description of:
1. Recruitment and Referral sources, including detailed descriptions of the census/rate of new cases and anticipated yield of eligible participants from each source;
2. Procedures that will be used to monitor enrollment and track/retain participants for follow-up assessments;
3. Strategies that will be used to ensure a diverse, representative sample;
4. 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); along with and corresponding solutions to address enrollment problems.
5. Evidence to support the feasibility of enrollment, including descriptions of prior experiences and yield from research efforts employing similar referral sources and/or strategies.
2.7 Study Timeline
Applications must provide a timeline for reaching important study benchmarks such as: (1) finalizing the study procedures and training participating clinical site staff; (2) finalizing the intervention manual and assessment protocols, including fidelity measures/procedures, where applicable; (3) enrollment benchmarks; (4) completing all subject assessments and data collection activities, including data quality checks; (5) analyzing and interpreting results; and (6) preparing de-identified data and relevant documentation to facilitate data sharing, as appropriate.
Section 4 Protocol Synopsis
4.4 Statistical Design and Power
Describe the analytic strategy and power calculations for data analyses to determine whether the family navigator model induced changes in the target(s) are associated with intended outcomes.
Section 5 - Other Clinical Trial-related Attachments
5.1 Other Clinical Trial-related Attachments
Applicants must upload the attachments for Intervention Manual/ Protocol Materials as separate files, as applicable. Applicants must use the “Intervention Manual/ Protocol Materials” to name these other attachments files. As appropriate, this may include screenshots of mobile interventions, technological specifications, training manuals or treatment algorithms.
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
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.
This initiative is not subject to intergovernmental review.
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.
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. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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, NIH. Applications that are incomplete or non-compliant will not be reviewed.
In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at email@example.com when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Use of Common Data Elements in NIH-funded Research
NIH encourages the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g., genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.
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.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
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).
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.
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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 there a description regarding how effective navigator models may optimize the delivery of mental health services, improve care coordination strategies and improve the ‘personalized match’ with appropriate treatment and services to ensure that therapeutic gains are maintained over time?
Does the application describe how proposed project will facilitate sustainability, scalability and enhance the navigator model’s potential for implementation and future uptake in diverse settings?
Does the application adequately describe how the project will contribute to the development of a navigator model intended to promote early access, engagement and coordination of mental health treatment and services for children and adolescents who are experiencing early symptoms of mental health problems?
As applicable, how adequate is the evidence that the family navigator model may reduce or eliminate racial, ethnic, gender or socio-economic disparities the delivery of services?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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 research team members have complementary areas of expertise? For the Senior/Key Personnel proposed, is there appropriate evidence of their experience and expertise at collaborating with community practice partners/providers, consumers, and relevant entities?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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 application describe any innovations in navigator model development, feasibility testing, research strategy, design or analytic approach, if they are employed, and how these may enhance the potential value of study results?
Is there a description of innovative technologies (e.g., use of dashboards, outcome tracking, and therapeutic milestone measurement, incorporation of health information technology) to assist navigator models in delivering personalized mental health care for adolescents?
Does the application identify new approaches to promote early access, engagement and coordination of mental health treatment and services for children and adolescents who are exhibiting early symptoms of mental health problems?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Does the application provide the empirical basis for the proposed targets/mechanisms that are presumed to account for changes in access, engagement and coordination of mental health services? Is there a plan for assessing target engagement? Is there a description of the analysis plan to determine whether the intervention leads to changes in the targets/mechanisms?
Is there a clear description of the mechanisms to detect the active elements of the navigator model that optimize the delivery of mental health services, enhance care coordination strategies and improve the ‘personalized match’ of needed service amount, intensity and frequency – as well as enhancing access, engagement and coordination of services among children and adolescents?
Does the application describe the proposed method for assessing the effectiveness and implementation of a family navigator model and specify the research strategies that will be used to monitor coordinated care strategies, clinical progress and measure clinical, functional and behavioral outcomes? Is there a justification of the sample size and rationale for the choice of methods proposed? Does the application describe plans to promote long-term sustainability?
Is there a clearly described systematic assessment of the acceptability/feasibility of the navigator strategy and quantification of the required resources for the assessment approach?
How scientifically sound and justified are the proposed analytic strategy and power calculations? What is the quality of the evidence that the analyses will determine whether intervention-induced changes in the target(s) are associated with the intended outcomes (i.e. mediation)?
Does the application utilize a deployment-focused approach (e.g., the incorporation of stakeholder perspectives, consideration of financial/workforce resources and clinical/administrative routines) in order to ensure a feasible, practice-ready navigator model and ensure the results will have utility for end-users?
Does the application provide evidence of the association between the intervention target(s) and the endpoint(s) of interest? Are the outcome measures validated and are stakeholder relevant outcomes included? Does the application describe the monitoring of fidelity in intervention delivery in community practice settings?
As appropriate, how adequate is the description of how the intervention strategy may reduce or eliminate racial, ethnic, gender or socio-economic disparities in the delivery of services and interventions? How sound and feasible are the plans to involve collaborations and/or input from community practice partners/providers, consumers and relevant decision-makers, as appropriate?
Does the application adequately address the following, if applicable
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
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?
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?
How well does the description of the sites justify their selection for involvement in the research?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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.
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified?
Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
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.
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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals, the committee will consider the progress made in the last funding period.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
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).
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 Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by National Institute of Mental Health, 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:
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. 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:
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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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.
Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA. For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file. Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
Cooperative Agreement Terms and Conditions of Award
A final RPPR, 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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
(Questions regarding application instructions and process, finding NIH grant
Email: GrantsInfo@nih.gov (preferred method of contact)
Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
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.
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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