This NOFO is a call to action in response to the mental health crisis in the United States. We seek applications that will study methods to increase access to evidence-based interventions and services for youth mental health, including those living in rural areas, inner cities, and other under-resourced areas, and youth experiencing housing and food insecurities and out-right homelessness. Applications should address research related to optimizing assessment, intervention and service strategies, overcoming challenges related to the workforce shortage, wait lists for treatment, integration of treatment and preventive interventions into settings where people are most likely to be best identified as needing care (eg: schools, social service, pediatric medicine and justice), and service interventions that address systemic barriers to access and quality of mental health care (structural, policy, organizational, value (cost/financing), management).

Funding Opportunity Number: PAR-25-310. Assistance Listing: 93.242. Funding Instrument: G. Category: HL.

PAR-25-310: Accelerating Solutions to Improve Access and Quality of Empirically-Supported Practices for Youth Mental Health (R01 Clinical Trial Optional) 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. 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 Accelerating Solutions to Improve Access and Quality of Empirically-Supported Practices for Youth Mental Health (R01 Clinical Trial Optional) R01 Research Project Grant 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 4, 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 Part 2, Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) Funding Opportunity Purpose This notice of funding opportunity (NOFO) is a call to action in response to the youth mental health crisis in the United States. NIMH seeks applications that will study methods to increase access to, and quality of, empirically-supported practices for youth mental health.

Applications may address research related to: optimizing assessment, intervention and service strategies; overcoming challenges related to workforce shortages and waitlists for treatment; integration of treatment and preventive interventions into settings where youth are most likely to be identified as needing care (e.g., schools, pediatric medicine, community organizations, social services, and juvenile justice), and service interventions that address systemic barriers to access and quality of mental health care (e.g., structural, policy, organizational, value in terms of cost/financing, management).

Funding Opportunity Goal(s) The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

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.

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 Application Guide and the NOFO) 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.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. 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 Key Definitions for this NOFO: Youth : For the purposes of this announcement, youth are defined to include children, adolescents, and youth transitioning to adulthood (i.e., birth to 25 years old).

Evidence-Based Intervention: Evidence-based preventive and therapeutic interventions are those that have demonstrated efficacy, safety, and tolerability, and are found to be effective in the general population. Interventions include drug, devices, psychotherapies, behavioral treatments, and case management services.

Empirically-Supported Practices : Empirically-supported practices include both evidence-based as well as evidence-informed preventive and therapeutic interventions, services, and implementation strategies. System intervention: System interventions target system(s) of care, rather than individuals (e.g., individual service users, family members, or providers).

The intervention focus could be across multiple organizational settings or systems (e.g., primary and specialty care, community clinics, schools, juvenile justice) or at multiple levels within a single organization or system (e.g., patient-, provider-, clinic-, and health system-levels).

The independent variable(s) therefore include(s) the manipulation of structural, organizational, procedural, and interpersonal factors and/or incorporate multiple implementation strategies to improve the delivery, effectiveness, and efficiency of mental health services within or across systems. Examples of system interventions include the Collaborative Care Model and Coordinated Specialty Care.

Implementation strategy: Methods or techniques designed to enhance adoption of a therapeutic, preventive, or services intervention. Examples include electronic clinical reminders, audit/feedback, training, and practice facilitation.

Under this NOFO, testing implementation strategies is appropriate for approaches that target systems of care and/or multiple levels within a system or setting, as well as implementation strategies that target provider behavior (e.g., a provider training or support activity like academic detailing).

Implementation strategies seek to improve: (1) acceptability, satisfaction, and perceived fit of extant evidence-based practices; (2) access to and engagement with evidence-based practices; (3) quality and fidelity to evidence-based care; and (4) uptake, scalability, and sustainability.

Hybrid effectiveness implementation trials (hybrid trials): A trial design that takes a dual focus in assessing clinical effectiveness and implementation.

Hybrid designs typically take 1 of 3 approaches: (a) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation (Type 1); (b) dual testing of clinical effectiveness and implementation interventions/strategies (Type 2); (c) testing of an implementation strategy while observing and gathering information on the clinical intervention’s impact on relevant clinical, functional, or population level outcomes (Type 3).

Deployment-focused: Deployment-focused design and testing systematically assesses and incorporates the perspectives of community and practice partners (e.g., consumers, providers, administrators, payers) and setting characteristics (e.g., workforce capacity; clinical workflows). This approach helps to ensure that the resultant interventions are feasible and scalable, and that the study results have utility for end-users.

Task shifting versus task sharing : Youth receive mental health services from a range of potential providers in a variety of settings (e.g., specialty mental health clinics, primary care, emergency departments, schools, justice system settings).

The application should justify the focus of the proposed intervention/services in terms of the alignment with the provider qualifications and setting capacity (e.g., settings outside healthcare systems or lacking clinical support might focus on identification, referral, and engagement with healthcare services or prevention).

Task-shifting approaches that involve using research resources or other unsustainable resources to train and supervise non-clinicians in the delivery of therapeutic interventions will be considered low priority.

Task-sharing models that propose and test clear roles for non-clinicians and incorporate scalable and sustainable approaches to training and supervision, safety monitoring, and credentialing to complement and extend the mental health workforce are responsive.

Task-sharing research should include collection of information useful to policy makers to develop credentialling or other system policies to support the non-licensed clinician if the model is found effective. This NOFO is intended to support research that addresses barriers youth and families encounter when accessing empirically-supported practices for mental health.

NIMH seeks applications with high public health impact that will study methods to increase access to, and quality of, empirically-supported practices for youth mental health, including but not limited to: youth and families who are affected by health disparities ; those who experiencing food insecurities, housing instability, and homelessness; and those living in rural areas, inner cities, and other under-resourced areas..

Applications may propose research related to optimizing assessment of risk and mental illness; optimizing and implementing prevention, treatment, and service interventions and strategies; overcoming challenges related to workforce shortages and wait lists for treatment; integration of treatment and preventive interventions into settings where youth are most likely to be identified as needing care (e.g., schools, pediatric medicine, community organizations, social services, and juvenile justice), and service interventions that address systemic barriers to access and quality of mental health care (e.g., structural, policy, organizational, value in terms of cost/financing, management).

Projects may also test the impact of policies and practices, interventions to facilitate care transitions and continuity across settings, and interventions to improve linkages/coordination across systems. As many as one in eleven children and adolescents in the United States are diagnosed with a mental health disorder, yet only a fraction of youth ever receive treatment.

Unmet treatment need for child and adolescent mental health problems is often greatest among populations with health disparities , those living in rural and inner-city areas, and those who experience housing and food insecurity.

These trends were exacerbated during the COVID-19 pandemic, leading the American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and the Children’s Hospital Association to declare a national emergency , while the Office of the U.S. Surgeon General issued an advisory statement on youth mental health.

In addition, the rate of suicide among youth increased 62% from 2007 to 2021, 105,000 youth were treated in an ED for self-harm injuries in 2020, and the age at first attempt is decreasing. Youth and families encounter many access barriers to high quality, empirically-supported mental health interventions and services.

These barriers include: (1) empirically-supported interventions that are not scalable or suitable for delivery in community settings; (2) empirically-supported preventive and therapeutic interventions that are not optimally effective or do not address the needs of youth and families; (3) a workforce that is not prepared to deliver empirically-supported mental health interventions for youth; (4) a poorly distributed workforce that is disincentivized to accept insurance, particularly Medicaid; ( 5) system and service barriers, including discontinuities across settings where youth are identified and receive mental health services (e.g., fragmented services across schools, primary care, specialty mental health clinics; discontinuities as youth transition to adulthood); and (6) a lack of decision support tools and quality measures to guide the delivery of interventions and services.

Specific Areas of Research Interest Studies that address the barrier of empirically-supported interventions that are not scalable or suitable for delivery in community settings (e.g., community mental health, schools, pediatric medicine, juvenile justice and other youth-serving settings), including but not limited to: Optimizing and testing interventions and services that are scalable and can be delivered with fidelity using available resources and personnel in community settings (e.g., incorporating technology and other design features that enhance implementation and scalability, and prevent threats to fidelity).

Optimizing multi-component interventions to identify critical content that drives outcomes and can be feasibly administered with fidelity in community settings. Leveraging multi-level, cross-sector partnerships among schools, businesses, health care systems, community-based organizations, and other community resources to advance the implementation and/or scale-up of effective mental health services across the continuum of services.

Studies that address the barrier of empirically-supported preventive and therapeutic interventions that are not optimally effective or do not address the needs of youth and families, including but not limited to: Multi-modal, integrated, or augmentative intervention approaches (e.g., combination treatments, sequenced interventions, stepped interventions), that address factors associated with suboptimal response among treatment-refractory groups in order to enhance effectiveness.

Modular preventive and treatment interventions that are personalized, efficient, effective, and can be more flexibly and feasibly implemented.

Optimized interventions that substantially improve intervention response, adherence, and/or engagement for racial and ethnic minority groups, individuals limited by language or cultural barriers, individuals with disabilities, individuals living in rural areas, groups that have been economically/socially disadvantaged, and other underserved groups.

The development, refinement, and testing of algorithms and strategies for identifying youth with and at risk for mental health disorders and for matching youth to interventions of appropriate intensity/dose, based on risk status or the severity of the mental health problem as well as the capacity of the youth or family to engage in services.

Studies that address the barrier of a workforce that is not prepared to deliver empirically-supported mental health interventions for youth, including but not limited to: Developing and testing scalable approaches, including technology-supported approaches to promote training to competence and sustained implementation fidelity in assessment and delivery of preventive, therapeutic, and services interventions.

Examining how technology might be used as scaffolding to support providers in implementing evidence-based practices with sustained fidelity. Task sharing models that propose and test clear roles for non-specialty providers, staff, peers, or lay persons and incorporate scalable and sustainable approaches to training and supervision, safety monitoring, and credentialing to complement and extend the mental health workforce.

Developing and validating pragmatic strategies for monitoring the quality of preventive, therapeutic, and services interventions to facilitate efforts at training, supervision, and quality monitoring/improvement.

Developing, testing, or comparing scalable models for supporting providers in the delivery of research supported services and preventing provider turnover and burnout (e.g., Extension for Community Healthcare Outcomes [ECHO], practice communities).

Studies that address the barrier of a poorly distributed workforce that is disincentivized to accept insurance, including but not limited to: Comparative economic evaluations of alternative implementation strategies that might be used to foster the delivery of the continuum of empirically-supported services in schools and other naturalistic settings and/or across phases of implementation.

Examining the effectiveness of specific crisis services in the context of alternatives, including comparative effectiveness and cost-effectiveness analyses, to promote implementation of high value services. Testing the effectiveness of reimbursement/payment models along the continuum of mental health services, including assessment of positive impacts and unintended consequences.

Identifying optimal incentives, including financial and other incentives, to encourage mental health providers to participate in insurance or in underserved areas. Modeling or comparing the impact and return on investment of alternative strategies for increasing the number of providers (e.g., training initiatives, recruitment strategies).

Studies that address system and service barriers, including discontinuities across settings where youth are identified and receive mental health services, including but not limited to: Developing, optimizing, and testing interventions and implementation strategies to enhance continuity in youth mental health care across developmental transitions (e.g., the transition to adulthood for youth with autism, severe mental illness, etc.).

Innovative interventions and implementation strategies to reduce disparities in service access, quality, and outcomes for racial and ethnic minority groups, individuals limited by language or cultural barriers, individuals with disabilities, individuals living in rural areas, groups that have been economically/socially disadvantaged, and other underserved groups.

Services interventions that can be used in non-mental health settings to promote detection, engagement, and facilitated referral of youth in need of mental health treatment (e.g., to Certified Community Behavioral Health Clinics or other mental health specialty services).

Navigator interventions to facilitate help-seeking, access, and engagement, and shared decision-making for mental health services or other services to meet social needs.

Interventions (including technology-based approaches) aimed at the patient-, family-, provider- and/or systems-level factors to address practical, systemic, and cultural barriers to, and facilitators of, risk detection, referral, and treatment of self-injurious behavior (SIB) and/or non-suicidal self-injury (NSSI), with attention to developmental factors in the targeted age group.

Comparing state and local policies regarding age of consent for services to examine how policies and practices impact service access and use among youth. Evaluating and comparing alternate payment models (APM) (e.g., integrated care, Accountable Care Organizations, etc.) for youth-centered services that facilitate cross-sector coordination between mental health, primary care, other health care, and social service providers.

Studies may also examine strategies for combining funding from multiple sources, including braiding, blending, sequencing, or other financing strategies. Interventions that utilize restorative justice approaches to address system- and structural-level factors that impact service access, use, and delivery, or risk and severity of mental illness.

Studies that address a lack of decision support tools to guide the delivery of interventions and services, including but not limited to: Utilizing administrative data sources (e.g., electronic health records, claims data) and data science and commensurate analytic approaches (e.g., predictive analytics, machine learning, etc.) to identify mental health risk and optimize delivery of mental health care.

Development and validation of decision support tools to guide the selection of empirically-supported practices to be offered within a given practice setting, including across multiple tiers (e.g., universal, selective, targeted prevention) based on the current need and available resources.

Development and validation of decision support to guide decision making for matching youth to intervention(s) and service(s) of appropriate intensity and focus, given the nature and severity of the presenting concerns.

Developing and validating tools for risk stratification that incorporate risk algorithms (e.g., EHR data, other routinely collected information, or screening responses) and can be used to guide decisions regarding the optimal level of care for youth exhibiting suicidal thoughts and behaviors. Scale and Scope of Research This NOFO uses the R01 research project grant mechanism to support both pilot stage and full-scale research projects.

The application should clearly specify the goals of the project and justify the methods (e.g., sample size, analytic strategy) and the requested resources (i.e., funds, investigator effort, project period) as appropriate to the proposed stage of science (i.e., pilot-stage project or full-scale project).

Pilot-stage projects s hould be designed to examine the feasibility of the research approach (e.g., feasibility of recruiting and retaining participants) should provide an opportunity to refine and pilot test the experimental protocols (e.g., assessment protocols and the experimental intervention protocol, as relevant), and should yield pilot data necessary for informing subsequent, well-powered studies.

Full-scale projects should be supported by pilot data and should be statistically powered to provide a definitive answer, such that the findings have potential to inform practice. Study designs may also address hypotheses regarding predictors and moderators of outcomes. This NOFO invites both clinical trials and projects that do not involve clinical trials.

Depending on the research question, a variety of data sources (e.g. electronic health records or claims data, prospectively collected participant-level data) and methodologically rigorous approaches may be indicated. These may include randomized controlled trials (RCTs), quasi-experimental designs with non-randomized comparison groups, time-series designs, and other designs of equivalent rigor and relevance.

Studies focused on intervention effectiveness and implementation strategies at the person level must include a hybrid effectiveness-implementation trial design that proposes to simultaneously evaluate the clinical impact of the intervention on symptoms, functional outcomes, or risk factors associated with a mental disorder and implementation factors or strategies that impact intervention access, engagement, quality, or sustainability.

For studies focused on intervention effectiveness and implementation strategies at the person level, at least one hypothesized mechanism of action (confirmation of target engagement) is required.

For studies focused on service/system level interventions, applicants should provide a conceptual model that justifies the empirical relationship between system interventions and strategies and outcome(s), and must propose analyses that assess how the interventions and strategies are associated with and account for changes in outcomes.

In both person-level and system-level intervention types, methodology should go beyond assessing only whether an intervention is effective, but what factors the intervention is addressing to mitigate issues like outcome, access, and quality barriers that contribute to the person-level intervention voltage drop that is observed when interventions are deployed in healthcare, community, and other settings.

For studies that test the effectiveness of therapeutic or preventative mental health interventions and related implementation strategies at the person level, NIMH supports intervention development work when there is a compelling empirical justification for the proposed augmentation, optimization, personalization, or sequencing approach.

This justification may be based on evidence that the unmodified intervention or strategy is associated with suboptimal clinical response, engagement, or adherence, is a poor cultural fit for specific populations, or is likely to encounter implementation challenges in routine care, school, community, or online settings (see recommendation 2. 4.

1, page 19 regarding the empirical justification for intervention adaptations in the NAMHC Workgroup Report, From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses) .

NIMH encourages optimization of service-ready interventions that can readily be integrated into practice and incorporate features specifically designed to prevent threats to implementation fidelity (e.g., using consumer-facing or provider-facing technology, including technology to support provider training and sustained implementation with fidelity).

NIMH encourages applications that include plans to quantify the time and resources required for provider training, supervision, and implementation of the intervention. NIMH encourages studies that maximize efficiencies by utilizing existing infrastructure to facilitate data collection, enhance the sustainability of the approach, and improve the feasibility of participant recruitment.

For example, existing infrastructure may include practice-based research networks, electronic medical records, administrative databases, patient registries, and routinely collected school data.

To expedite the translations into practice, this NOFO is intended to support research that reflects a deployment-focused model of system design and testing that meaningfully considers the perspective of key end users and beneficiaries of the research (e.g., service users, health system decision makers, professional practice and educational organizations, third-party payers, public mental health policymakers, front line clinicians, representatives from the population of interest) and the characteristics of the settings (e.g., resources, including workforce capacity; existing clinical workflows) where optimized mental health interventions and services are intended to be implemented.

Collaborations between academic researchers and clinical or community practice partners or networks is expected. Preliminary data should reflect an existing partnership between academia and the system or service setting.

Studies should capitalize on existing infrastructure (e.g., practice-based research networks such as the NIMH-supported Early Psychosis Intervention Network [EPINET]; NIMH-sponsored ALACRITY Research Centers or Suicide Research Centers; SAMHSA’s Certified Community Behavioral Health Clinics , Project AWARE [Advancing Wellness and Resiliency in Education] program, or other grantee networks; NIH's Communities Advancing Research Equity for Health ; public and private health care systems, school systems, electronic medical records, administrative databases, patient registries, institutions with Clinical and Translational Science Awards) to increase the relevancy of the system intervention and implementation strategies tested.

In accordance with the NIMH Strategic Framework for Addressing Youth Mental Health Disparities , NIMH is committed to supporting research that reduces disparities and advances health in youth mental health interventions, services, and outcomes.

As such, this NOFO encourages research that seeks to reduce disparities in outcomes for racial and ethnic minority groups (e.g., American Indian or Alaska Native, Asian, Black or African American, Latino or Hispanic, and/or Native Hawaiian or Pacific Islander youth), individuals limited by language or cultural barriers, individuals with disabilities, individuals living in rural areas, groups that have been economically/socially disadvantaged, and other underserved groups.

This NOFO strongly encourages intervention and services research that includes plans to address drivers of disparities in mental health outcomes and that tests research-informed strategies that are relevant across a variety of individuals. Primary outcome measures should be validated, generally accepted by the field, and considered in context of NIMH's requirements for use of common data elements .

Given the emphasis on practice-relevant questions, outcomes of interest extend beyond symptom reduction to include short- and long-term assessment of patient-centered outcomes, including changes in functioning across domains (such as school, employment, family, peer functioning) and other key outcomes of interest/importance to key stakeholders (e.g., staffing, efficiency, safety, value, access, engagement, or other factors related to the eventual implementation, scaling, and sustainment of new treatment, preventive, and/or services approaches).

Applications Not Responsive to this NOFO include: The following types of studies are not responsive to this NOFO. Applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding. Applications that are not focused on interventions and/or services for youth (i.e., ages birth to 25 years).

Psychopathology-focused studies whose purpose is to examine risk, protective, and etiological factors, rather than focusing on informing and/or testing interventions and services for youth.

Applications that propose to test interventions and service delivery in research settings rather than routine care, community, school, or online settings and/or propose the use of research therapists or include other features specific to research or academic contexts (i.e., studies that incorporate features or involve resources that are not representative of typical practice settings or substantially impact generalizability).

For studies that involve developing and testing person-level preventive or therapeutic interventions or implementation strategies : Applications that do not propose a hybrid effectiveness-implementation trial design.

For studies that involve developing and testing person-level preventive or therapeutic interventions or implementation strategies : Applications that do not propose an evaluation of the mechanism(s) of action and its impact on the primary outcomes, including the following components:(1) specified mechanism(s) of action; (2) measurement plans designed to assess the mechanism(s) of action and clinical outcomes in the intervention setting; and (3) analytic plan for evaluating whether intervention-induced mechanism(s) of action are associated with outcomes.

For studies that involve testing system-level interventions : Applications that do not: (1) explicitly test how, why, for whom, and/or in which settings or under what circumstances the system intervention may be effective (e.g., using moderator, mediator analysis, temporally organized dismantling designs); and (2) include an explicit analytic plan and specify the variables to be measured.

Studies that involve developing novel interventions that are grounded in emerging findings from basic science, rather than involving empirically-supported interventions and targets that are appropriate for testing and delivery in practice settings.

Studies focused on stigma or health literacy that examine knowledge about or attitudes towards mental health and mental health care without also examining mental health policy, actual service access, engagement, quality and/or outcomes of care.

Multi-site trials: This NOFO may be used for support for multi-site trials that require participation of two or more collaborative research sites for completion of the study (e.g., in order to increase sample size, accelerate recruitment, or increase sample complexity), with subcontracts to support enrollment and data collection at additional research sites and multiple PI/PD arrangements for research site PIs who contribute complementary research expertise, as appropriate.

Suicide-Related Outcomes: Effective prevention and treatment of mental illness have the potential to reduce morbidity and mortality associated with suicide attempts and deaths (see https://www. hhs. gov/programs/prevention-and-wellness/mental-health-substance-abuse/national-strategy-suicide-prevention/index.

html ). Lack of attention to the assessment of these outcomes has limited our understanding of the degree to which effective mental health interventions might offer prophylaxis. Accordingly, NIMH encourages research that includes assessment of suicidal behavior in clinical trials using strategies that facilitate data sharing and harmonization (see NOT-MH-23-100 and PhenX Toolkit | National Institutes of Health .

Data and Safety Monitoring: 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 and Conducting Research with Participants at Elevated Risk for Suicide: Considerations for Researchers ).

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. Applications with data collection plans that involve multiple respondent groups should include human subject protections, consenting procedures, and planned enrollment tables for each participant group.

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. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII.

Other Information for award authorities and regulations. 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 $4,000,000 in FY25 to fund this NOFO, contingent on NIH appropriations and the submission of a sufficient number of meritorious applications. For funding FY26 and FY27, the number of awards is contingent on NIH appropriations and the submission of meritorious applications.

Application budgets are not limited but need to reflect the actual needs of the proposed project. The proposed project period should be justified based on the scope of research. The maximum project period is 5 years; however, applicants are strongly encouraged to consider efficiencies and projects of shorter duration may be prioritized.

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