Pilot Research Opportunities in Crisis Response Services for Suicide Prevention Research (R34 Clinical Trial Optional)

Pilot Research Opportunities in Crisis Response Services for Suicide Prevention Research (R34 Clinical Trial Optional) is sponsored by National Institute of Mental Health (NIMH) - NIH. This program supports pilot research in crisis response services for suicide prevention, aiming to develop and test interventions and strategies.

Expired RFA-MH-25-136: Pilot Research Opportunities in Crisis Response Services for Suicide Prevention (R34 Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

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 ) Components of Participating Organizations National Institute of Mental Health ( NIMH ) Funding Opportunity Title Pilot Research Opportunities in Crisis Response Services for Suicide Prevention (R34 Clinical Trial Optional) March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose This NOFO seeks to promote pilot exploratory/developmental research examining the effectiveness and implementation of crisis response services, approaches to improve the quality and outcomes of services, and the impact of state and local policy on implementation and outcomes.

Research is sought that is conducted in real-world settings, where a wide range of clinical presentations, psychosocial factors, age-related characteristics (e.g., youth; adult; older adult), geographic context (rural/remote settings), racial/ethnic and cultural considerations, and health disparities influence the types of care that are provided. Studies are encouraged that address the continuum of crisis service systems.

Support for larger-scale or fully-powered studies is provided through a companion NOFO that utilizes the R01 mechanism (RFA-MH-25-135; Research Opportunities in Crisis Response Services for Suicide Prevention (R01 Clinical Trial Optional)).

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to application due date Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

New Date May 24, 2025 per NOT-OD-25-113 (Originally June 03, 2025) Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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 Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description The National Suicide Hotline Designation Act of 2020 designated "9-8-8" as the universal telephone number in the United States (U.S.) for the National Suicide and Crisis Lifeline , intended to address distress among those with mental and substance use problems through a crisis hotline system.

988 was built on the infrastructure of the existing National Suicide Prevention Lifeline. The goal of crisis services such as 988 is to provide someone to talk to, someone to respond, and someplace to go for help when needed. The Substance Abuse and Mental Health Services Administration (SAMHSA) is the lead federal agency providing funding and support to states in 988 implementation ( https://www.

samhsa. gov/find-help/988 ). More detail on 988 implementation can be found here ( https://www.

samhsa. gov/sites/default/files/saving-lives-american-988-quality-service-plan. pdf ).

SAMHSA sees 988 as a first step towards a transformed crisis care system in the U.S., and has made significant investments to support the newly expanded crisis response services offered through 988, including investments to strengthen and expand the existing Lifeline network operations, the crisis call center workforce, telephone/chat/text infrastructure, and mobile crisis response teams.

In addition to their therapeutic value, effective crisis systems that support individuals in suicide distress have been reported to be successful diversions from unnecessary hospital admissions, arrest, and incarceration, in part, by supporting emergency care that optimizes first responder teams, including law enforcement.

As states and localities build, increase, and/or improve their existing crisis service systems, it will be critical to understand which approaches are most effective. Across the continuum of crisis services, measurement-based care approaches to determine the effectiveness, quality, and outcomes of crisis services will be needed to demonstrate policy and intervention effectiveness and identify areas for further improvement.

This NOFO seeks to promote pilot exploratory/developmental research examining the effectiveness and implementation of crisis response services, approaches to improve the quality and outcomes of services, and the impact of state and local policy on implementation and outcomes.

Research is sought that is conducted in real-world settings, where a wide range of clinical presentations, psychosocial factors, age-related characteristics (e.g., youth; adult; older adult), geographic context (rural/remote settings), racial/ethnic and cultural considerations, and health disparities influence the types of care that are provided.

Studies are encouraged that address the continuum of crisis service systems, as well as applications that address crisis services for children and under-resourced populations. Topics of research interest span the crisis care continuum – including having someone to talk to, someone to respond, and somewhere to go.

Projects should include clearly operationalized research-practice partnerships that inform study design and ensure findings that can be readily put into practice.

Projects should include plans to involve collaborations and/or input from community practice partners/providers, consumers, and relevant policymakers in a manner that informs the research (e.g., to help ensure the interventions/service delivery approaches are acceptable, feasible, and scalable) and helps to ensure the results will have utility.

While this NOFO is not intended to support description or evaluation of local practices, research that involves rigorous examination of factors that impact or account for the effectiveness of existing crisis service models or practices (e.g., research on mechanisms of action for existing practices) is considered responsive.

Specific Areas of Research Interest Areas of interest include (but are not limited to) : Research examining the effectiveness and implementation of crisis response services (e.g., studies that test or compare alternative approaches) that utilize data supporting examination of post-acute stabilization: Pilot studies to assess the feasibility and preliminary effectiveness of call center strategies to address distress and coordinate care.

Pilot studies to assess approaches to deploy mobile crisis outreach and support. Pilot testing approaches to diagnose and provide stabilization of suicide risk and co-occurring mental health concerns. Analyzing approaches to promote sustained engagement with appropriate mental health services, and strategies for facilitating effective referrals and follow-up.

Pilot testing of strategies to link individuals in crisis to effective, available outpatient care (e.g., Certified Community Behavioral Health Centers). Examining outcomes of crisis services across the lifespan (e.g., school age youth; transitional age youth, adults and older adults).

Pilot studies to assess the feasibility of implementation of crisis services in rural or remote areas including partnership with 911 and related emergency medical services spectrum. Examine the impact of strategies to optimize police referral to enhance type and effectiveness of service use and patient-level outcomes, informed in part by individual and community preferences.

Research examining approaches to improve the quality and outcomes of services: Pilot studies to optimize, develop, refine, and examine the preliminary validity and utility of decision support tools (e.g., decision-support tools for risk stratification that could facilitate efforts to match individuals to the appropriate intensity).

Pilot testing of pragmatic strategies that can be used to monitor the quality of crisis services in practice settings. Pilot studies that aim to develop and test the preliminary effectiveness of workforce training and support tools (e.g., testing and comparing strategies for training providers to initial competence and for promoting sustained fidelity in the delivery of research-supported services).

Pilot studies to examine the use of technology to augment or enhance responsiveness and effectiveness of services. Research examining the impact of state and local policy on implementation and outcomes: Pilot studies to investigate whether and to what extent financing mechanisms, policies, regulations, and healthcare system rules optimize patient-level outcomes (including suicidal behavior and co-occurring mental health crises).

Examples may include identifying optimal: Organizational resources, including call center capacity, number of call center workers, text capability. Levels of funding and types of expenditures, including from federal and state resources, user fees, Medicaid and/or private insurers.

State capacity (optimal investment in workforce and technology to serve the state’s population), including examining the impact on patient-level outcomes when state capacity is exceeded. Pilot studies to identify mutable factors and policy interventions that can address disparities (e.g., by race/ethnicity, age, geographic location, and other factors) in the knowledge of 988, use of 988, types of referrals made during a 988 call.

Pilot studies to assess the preliminary effectiveness of incentives to attract and retain a high-quality workforce (e.g., reimbursement rates, certification requirements, cross-state licensing, flexible working arrangements). Pilot studies to evaluate outreach strategies that have the most impact on 988 utilization, particularly for under-served communities.

Pilot studies to analyze the impact of 988 utilization on other state resources, e.g., the conditions under which positive or negative unintended consequences occur (e.g., on emergency departments, outpatient mental health services, health and safety resources, police resources, domestic violence resources).

This R34 NOFO supports projects designed to (1) examine feasibility (e.g., ability to recruit and retain participants); (2) refine and pilot test experimental protocols, including assessment protocols and experimental intervention protocols, as relevant; and (3) yield pilot data necessary for informing next steps and for enhancing the probability of obtaining meaningful results in subsequent, well-powered R01-level studies.

The scope of research for such pilot research projects is generally analogous to the scope of research described in the NIMH R34 Research Mechanisms for Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions ( PAR-21-131 ) or for Pilot Services Research Not Involving Clinical Trials ( PAR-23-105 ).

Support for larger-scale or fully-powered studies is provided through a companion NOFO that utilizes the R01 mechanisms ( RFA-MH-25-135 ; Research Opportunities in Crisis Response Services for Suicide Prevention (R01 Clinical Trial Optional)).

Projects should describe how the proposed research will generate data that will lead to a firm conclusion about the feasibility of a regular research project grant (e.g., an R01 application) and provide information about the anticipated scope and goals of intended future work. Depending on the research question, a variety of methodologically rigorous approaches may be indicated.

For example, for studies that involve testing and comparing alternative strategies, designs may include randomized controlled trials (RCTs) and variants (e.g., stepped wedge cluster randomized trial designs), quasi-experimental designs with non-randomized comparison groups (e.g., instrumental variables, propensity score matching), 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 trade-off between maximizing internal and external validity; the design that is proposed should be justified, accordingly, in the application.

All applications that propose clinical trials must follow the NIMH’s experimental therapeutics approach to intervention development and testing (see https://www. nimh. nih.

gov/funding/opportunities-announcements/clinical-trials-foas/index. shtml ). That is, the scope of work must include specification of targets/mechanisms and assessment of intervention induced changes in the presumed targets/mechanisms that are hypothesized to account for the intervention’s outcomes.

In this manner, the results of the trial should advance knowledge regarding therapeutic change mechanisms and be informative regardless of trial outcomes (e.g., in the event of negative results, information about whether the intervention was successful at engaging its targets can facilitate interpretation.

Intervention "targets" and change mechanisms will vary depending on the nature of the intervention, but in all cases should be empirically justified. Targets/mechanisms for services interventions might involve mutable consumer- or provider- behaviors, or organizational-/system- level factors that are intervened upon in order to improve access, continuity, quality, effectiveness, and/or value of services.

NIMH is committed to supporting research that reduces disparities in prevalence, course and outcomes of mental illnesses, and advances effectiveness in mental health interventions, services, and outcomes.

Accordingly, this NOFO encourages research studies that examine approaches that can be used to reduce disparities, for example, racial and ethnic minority groups, individuals limited by language or cultural barriers, and individuals living in rural areas.

Depending on the methodology and/or research question, a Community Advisory Board (CAB) might be appropriate for advising the investigator team regarding engaging community partners, ensuring the feasibility, accessibility and validity of measurement-based services, and interpreting the results.

NIMH encourages research on potentially scalable preventive, therapeutic, and services interventions that focuses on practice-relevant questions. Accordingly, collaborations between academic researchers and clinical or community practice partners or networks are encouraged.

This includes studies that capitalize on practice infrastructure, including but not limited to SAMHSA-supported 988 Suicide and Crisis Lifeline services and training infrastructure, and crisis services provided through outpatient mental health treatment systems and settings, including but not limited to Certified Community Behavioral Health Clinics (CCBHCs) funded through the SAMHSA expansion grant program and CCBHCs participating in their states’ Section 223 CCBHC Medicaid demonstration program, or as a part of other state programs where the CCBHCs are meeting the federal CCBHC certification criteria When possible, NIMH encourages applications that leverage existing research resources.

To facilitate the ultimate translation into practice, NIMH encourages research and clinical approaches that incorporate the use of routinely collected data (e.g., electronic medical records, patient registries, other administrative databases) to increase the efficiency of participant recruitment (i.e., more rapid identification and enrollment) to facilitate the collection of practice-relevant data (e.g., clinical characteristics; stakeholder-relevant outcomes, including mental health and general health care utilization; data on longer-term outcomes; data regarding the value and efficiency of intervention approaches).

For studies that involve the assessment of patient-level outcomes, plans are expected that describe the assessment of suicidal behavior and related outcomes using strategies that can facilitate integration and sharing of data (e.g., see NOT-MH-15-009 and https://www. phenxtoolkit. org/ for constructs and corresponding assessment strategies), as appropriate, or provide a rationale for excluding such measures if they are not included.

Accordingly, the application should provide the rationale for the selection of suicide-related constructs and corresponding assessment instruments (e.g., measures of ideation, attempts), the time periods assessed (e.g., lifetime history, current), and the assessment schedule for administration (e.g., baseline, during intervention, post-intervention, follow up), taking into account the nature of the target population, participant burden, etc. The application should also address provisions for clinical management when suicidal behavior is reported.

In situations where it is not appropriate or feasible to include assessment of suicide outcomes due to the nature of the intervention (e.g., services interventions that target provider behavior or systems-level factors), the target population (e.g., very young children), or unique issues related to participant burden or safety/monitoring concerns, the application should provide an appropriate justification for excluding these assessments.

Applications Not Responsive to this NOFO The following are projects that will be considered non-responsive and will not be reviewed: Applications whose scope of work involves providing or implementing crisis services without examining research questions (e.g., applications requesting support for the creation of a clinic or center).

Applications that are not focused on understanding or testing crisis response services for suicide prevention. Applications that involve describing or evaluating local practices without examining clearly articulated research questions. Applications that propose clinical trials that do not align with the NIMH experimental therapeutics framework (see above).

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring ( NOT-MH-19-027 ). The application's PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, should reflect the policies and guidance in this notice.

Plans for the protection of research participants 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.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NIMH intends to commit up to $2,000,000 total costs in FY 2025 and in FY 2026 to fund approximately 3-5 new awards each year in response to this NOFO and the companion NOFO RFA-MH-25-135. R34 budgets are limited to $225,000 per year and $450,000 over the 3-year project period.

The scope of the proposed project should determine the project period. The maximum project period is 3 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (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 Recognized) Eligible Agencies of the Federal Government 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 Organizations) 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 How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

Grants. gov – Applicants must have an active SAM registration in order to complete the Grants. gov registration.

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

Obtaining an eRA Commons account can take up to 2 weeks. Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for 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 How to Apply - Application Guide . This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1. 2 Definition of Terms.

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, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. 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 instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO. All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Research Strategy : As part of the Research Strategy, the application must include the following information: 1) Describe how the study contributes to new knowledge, and/or has the potential to contribute significantly to improved outcomes.

2) Address the potential public health impact of the proposed work in terms of 1) reach and effect on the target population and/or 2) meaningfulness of the anticipated outcome(s) compared to existing approaches and/or current state of science in the topic area.

3) Detail how the proposed research will generate data that will lead to a firm conclusion about the feasibility of a subsequent research project grant (e.g., an R01 application) and provide information about the anticipated scope and goals of intended future work.

1) Describe plans to involve collaborations and/or input from community practice partners/providers, consumers, and relevant policymakers in a manner that informs the research (e.g., to help ensure the interventions/service delivery approaches are acceptable, feasible, and scalable) and helps to ensure the results will have utility. 1) Describe how the methods proposed are appropriate to address the research question(s).

2) Provide evidence that outcome measures are valid and reliable, including measures of outcomes that are meaningful to the stakeholders involved. 3) For studies that involve the assessment of patient-level outcomes, describe plans for the detection of suicidal behavior/ideation and non-suicidal self-harm and for clinical management to reduce subject risk when these factors are identified.

4) For applications proposing a clinical trial: Detail the plan to address whether the intervention engages the mechanism that is presumed to underlie the intervention effects (the mechanism that accounts for changes in clinical/ functional outcomes, changes in provider behavior, etc.).

Include the following: The conceptual framework that clearly identifies the target(s)/mechanism(s) and the empirical evidence linking the target(s)/mechanism(s) to the clinical symptoms, functional deficits, or patient-, provider- or system-level behaviors/processes that the intervention seeks to improve; Plans for assessing engagement of the target(s)/mechanism(s) using valid measures that are as direct and objective as is feasible in the effectiveness context, including the specific measures, the assessment schedule, and the justification for the assessment strategy (e.g., evidence regarding the validity and feasibility of the proposed measures in the effectiveness context); An analysis plan for a preliminary examination of whether the intervention engages the target(s) and whether intervention-induced changes in the target(s) are associated with and account for clinical benefit, as appropriate in the context of the pilot study.

In the case of multi-component interventions, the application should specify the conceptual basis, assessment plan, and analytic strategy, as detailed above, for the target(s)/mechanism(s) corresponding to each intervention component, as appropriate in the effectiveness context.

1) Describe how the study will leverage resources and expertise from existing infrastructure or utilize other available resources to increase the efficiency of participant recruitment and data collection. Or, provide a justification in the event that such efficiencies cannot be incorporated.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide . Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. To advance the goal of advancing research through widespread data sharing among researchers, investigators funded by NIMH under this NOFO are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-23-100 ).

Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this NOFO are expected to use these technologies to submit data to NDA.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission.

The NDA website provides two tools to help investigators develop appropriate strategies: 1) t he NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page .

Investigators are expected to certify the quality of all data generated by grants funded under this NOFO prior to submission to NDA and review their data for accuracy after submission. Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication, or