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

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 is sponsored by Department of Health and Human Services and National Institutes of Health. This funding opportunity supports pilot work in preparation for larger scale projects that will develop and test navigator models to promote early access, engagement, coordination, and optimization of mental health treatment and services for children and adolescents experiencing…

Expired PAR-17-265: 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) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute of Mental Health ( NIMH ) Funding Opportunity Title 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) R01 Research Project Grant December 5, 2017 - This PAR has been reissued as PAR-18-428 .

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PAR-17-266 , R34 Planning Grant Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose 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-17-266 supporting pilot studies in preparation for the larger-scale studies Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date dates apply , by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates ***This FOA is being issued with limited due dates to accommodate the transition from FORMS-D to FORMS-E application packages.

This FOA will be reissued for additional due date(s) on or after January 25, 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) New Date December 5, 2017 per issuance of PAR-18-428 .

(Original Expiration Date: January 8, 2018) It is critical that applicants follow the Research (R) Instructions (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.

Part 1. Overview Information Part 2. Full Text of the Announcement I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

Funding Opportunity Description 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 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 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 that applications that propose to test the effectiveness of traditional therapeutic or preventive interventions, rather than testing navigator models that 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 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-17-266 (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).

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. 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. Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Funds Available and Anticipated Number of Awards 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 Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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: o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible 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 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 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. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

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 must have an active DUNS number and SAM registration in order to complete the 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 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 This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility 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 A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission 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 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. 2. Content and Form of Application Submission It is critical that applicants follow the Research (R) Instructions (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 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 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: All page limitations described in the SF424 Application 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 All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide 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.

Attachments: Applicants should upload the attachments described below, as separate files. Applicants should use the headers below to name these other attachment files (i.e., Recruitment and Study Timeline and Intervention Manual/Protocol Materials (if applicable)) and use the format, below, in their description of the Participant Recruitment/Retention Procedures I.

Recruitment and Study Timeline (Required): Applications that lack this attachment will be considered incomplete and will not be reviewed. This attachment must be no more than 4 pages, and include Sections A and B described below. Applications that exceed this limit will not be A.

Participant Recruitment and Retention Procedures. 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, 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); 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. B.

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.

II. Intervention Manual/Protocol Materials (if applicable): It is strongly recommended that intervention protocols and manuals be included as an Other Attachment, if applicable. As appropriate, this may include screenshots of mobile interventions, technological specifications, training manuals or treatment algorithms.

SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide 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 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.

Provide a justification of the sample size and present a clear rational for the choice of methods proposed, explaining how the selected research methods minimize confounds that may limit the ability to infer Describe appropriate study milestones that are clearly defined for all of the study aims. The milestones should be feasible and quantifiable and described in the context of the study timeline.

Potential challenges that may result in enrollment shortfalls should be discussed, along with and corresponding solutions to address enrollment problems. 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.

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.

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: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

In order to advance the goal of furthering research by 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 ). Applicants should explain what type of data are appropriate and available for not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide 3. Unique Entity Identifier and System for Award Management (SAM) 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 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 Organizations must submit applications to Grants. gov