R01: Digital Health Technologies for Behavioral Health in Youth is a grant from the National Institute of Mental Health (NIMH) that funds clinical trial research developing and optimizing digital health interventions for youth behavioral health.

The program supports research creating scalable, evidence-based technologies—including apps, sensors, and AI tools—to prevent, diagnose, or treat mental health conditions in children and adolescents. Awards are $500,000 or more per year. Eligible applicants include universities, nonprofits, for-profit organizations, state and local governments, and tribal entities.

A clinical trial component is required.

PAR-25-136: Laboratories to Optimize Digital Health (R01 Clinical Trial Required) 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 Laboratories to Optimize Digital Health (R01 Clinical Trial Required) R01 Research Project Grant Notices of Special Interest associated with this funding opportunity 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 Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose NIMH seeks applications for innovative research projects to test strategies to increase the reach, efficiency, effectiveness, and quality of digital mental health interventions which may impact mental health outcomes, including suicide behaviors and serious mental illness.

This Notice of Funding Opportunity (NOFO) is intended to support the development of digital health test beds that leverage well-established digital health platforms and infrastructure to rapidly refine and optimize existing evidence-based digital health interventions and to conduct clinical research testing digital mental health interventions that are statistically powered to provide a definitive answer regarding the intervention's effectiveness particularly in populations who experience health disparities and vulnerable populations.

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 NIMH seeks applications for innovative research projects to test strategies to increase the reach, efficiency, effectiveness, and quality of digital mental health interventions which may impact mental health outcomes, including suicide behaviors and serious mental illness.

This NOFO is intended to support the development of digital health test beds that leverage well-established digital health platforms and infrastructure to rapidly refine and optimize existing evidence-based digital health interventions and conduct clinical research testing digital mental health interventions that are statistically powered to provide a definitive answer regarding the intervention's effectiveness particularly in populations who experience health disparities and vulnerable populations.

The healthcare landscape in the United States is constantly changing, creating new challenges to the delivery of high-quality treatments and services to children, youth, adults, and older adults with unmet or under-met mental health needs.

Epidemiological findings suggest that approximately one-half of the United States population meets lifetime criteria for a mental disorder, and approximately one-quarter of the population meets criteria in any given year. However, only one-half of people with any mental health disorder and only two-thirds of people with a serious mental health disorder received mental health services in the previous year.

Of those that find their way into mental health care, many fall out of care and/or do not receive guideline concordant treatment, including suicide risk assessment and evidence-based preventive interventions. Disparities in population status (e.g., members of racial, ethnic, and rural communities communities), a fragmented healthcare system, provider shortages, healthcare affordability, and other factors moderate these findings.

Digital health incorporates mobile health (mHealth) and health information technology (smartphones, wearable sensors, internet platforms, and electronic health records) with biological, social, and behavioral data. Digital health technology offers unprecedented opportunities to help consumers, clinicians, and researchers measure, manage, and improve health and productivity.

These tools also have the potential to improve our understanding of mental illness, to track the course of illnesses and recovery, and to provide and enhance mental health care.

Digital mental health interventions are treatments that aim to improve mental health and deliver the treatment as a standalone intervention or as an adjunct to face-to-face interventions via a digital health platform (including mobile phone, website, virtual reality systems, and offline computer programs).

Digital health interventions offer the potential to bridge the treatment gap and provide evidence-based interventions to the many individuals who currently are unable to access treatments. Over the last decade, NIMH has supported the development and testing of digital health technology, with a focus on establishing the efficacy of digital health assessments and digital health interventions.

This research has demonstrated that digital health technology can be used as a means for reducing symptoms. However, with few exceptions, the majority of NIMH-funded research of digital health interventions has not moved into or beyond the effectiveness stage of research. In contrast to federally funded mental health research, the pace of commercial technology development has progressed rapidly.

Over the last 5 years commercially available digital health platforms for mental health have gained considerable traction in the marketplace. Recent estimates suggest that focus on mental health and a significant cross-section of consumers are regularly utilizing digital health technology to access treatment for mental health.

As digital health technology for mental health is being increasingly used to provide standalone self-managed interventions and/or to supplement in-person treatment, well-designed pragmatic research is necessary to evaluate the effectiveness of existing digital health technology, optimize existing digital health interventions, and examine factors related to uptake and engagement.

Research Scope and Objectives This NOFO uses the R01 mechanism and is intended to promote partnerships between software developers and academic researchers and leverage existing digital mental health platform infrastructure. It is expected that the proposed digital health platforms will be well established, provide evidence-based interventions and have a substantial existing user base.

It is also expected that these partnerships will enable applicants to conduct research both to rapidly test ideas and conduct exploratory research as well secondary data analyses and large cost-effective pragmatic effectiveness trials.

While this NOFO will support testing of evidence-based digital health intervention approaches, it is not intended to support the translation of existing face-to-face treatments into technology-based applications. Investigators are strongly encouraged to review NOT-MH-18-031 for guidance concerning the NIMH high priority topics in digital mental health.

For this NOFO, NIMH requires investigators to develop and leverage partnerships with digital health developers and existing well-established digital health delivery platforms, so that the research follows a deployment-focused model of services design and testing.

Deployment-focused studies take into account the perspective of relevant stakeholders and key characteristics of settings intended to implement optimized digital mental health interventions.

Potential stakeholders include, but are not limited to, federal agencies (e.g., Centers for Medicare and Medicaid Services, Substance Abuse and Mental Health Services Administration, Health Resources and Services Administration, Department of Defense, Department of Veterans Affairs); commercial health insurers/funders; public and commercial disability insurers; employers and other payers; delivery systems; professional/trade associations; accrediting and licensing organizations; medical education and other training programs; clinicians; vendors of information technology and other relevant products/services; service users; family members; and community organizations.

The applicant should identify key stakeholders based on the characteristics of the proposed intervention and how the intervention will be deployed within service systems. Such communication and collaboration will ensure findings are relevant and practical, create opportunities for research that is not otherwise feasible, and enable stakeholders to anticipate relevant research initiatives in their planning and activities.

Where appropriate, it is strongly encouraged that applicants seek consultation from the Food and Drug Administration for guidance related to regulatory approval/certification of the digital mental health interventions that are being tested.

Consistent with the NIMH Experimental Therapeutics approach to intervention development and testing, this NOFO is intended to support studies that not only examine the intervention effects on outcomes of interest, but also inform understanding of the intervention’s mechanisms of action.

As such, the scope of work must include specification of intervention target(s)/mechanism(s) and assessment and analysis of intervention-induced changes in the presumed target(s)/mechanism(s) that are hypothesized to account for the intervention outcomes (see the NIMH Clinical Trials web page for additional information).

Proposed studies should capitalize on existing infrastructure (e.g., existing evidence based digital mental health platforms) to increase the efficiency of participant recruitment, and data collection and management.

Platforms should be well established with a sufficient existing user base (i.e. at least a thousand or more active users) to support nimble intervention refinement and testing with appropriate sample size to achieve adequate statistical power. Of note, the goal of this funding announcement is not just to conduct pragmatic trials on digital health platforms.

Rather, applicants must propose additional research beyond the primary effectiveness trial that capitalize on the unique features of the proposed digital health platform.

Such additional research might include but is not limited to: analyses of baseline characteristics of users to develop treatment matching algorithms, analyses of existing data to determine the optimal sequence and dose of the digital intervention and to further understand the etiology, pathophysiology, and trajectories of mental health disorders, development and testing of real time adaptive customized interventions that augment the base digital intervention.

Examples of responsive applications include, but are not limited to, studies that: Test strategies to rapidly identify and enroll participants, and parametrically refine intervention content, dose, and delivery parameters to optimize the digital health intervention&#1#146;s therapeutic benefit and efficiency.

Test the effectiveness of digital health platforms to optimize the benefit of in-person treatment and bridge therapy sessions and promote between-session skill practice/acquisition. Develop and test adaptive interventions and just-in-time interventions that can be ‘pushed out’ via mobile technology based on information regarding the individual’s current state.

For example, interventions that prompt users to complete an assessment at specific times during the day or passive ascertainment of changes in clinical status, immediately followed by provision of behavioral support, such as self-management strategies.

Test strategies to deliver digital mental health interventions designed to overcome well-documented uptake and adherence challenges with digital health interventions (e.g., using research-informed approaches to enhance motivation and promote continued engagement).

Test digital health technology-driven approaches to improve access to and promote engagement with and continuity of care during known periods of heightened risk, such as care transitions between systems (e.g., handoffs between emergency departments and inpatient psychiatric or substance abuse treatment; transitions between outpatient mental health/substance abuse programs and primary care settings).

Leverage patterns of use to identify subcategories of users (i.e., brief users, social users, persistent users) and develop and test strategies to encourage continued engagement. Within digital health platforms that connect users with paraprofessionals and clinicians, test flexible patient matching algorithms and strategies to increase treatment fidelity to Evidence Based Practices (EBPs).

Test whether digital interventions can mitigate health disparities in access, service utilization, and mental health outcomes. Utilize electronic health record data in conjunction with digital health interventions to examine the clinical epidemiology, service utilization, response to treatment, within or across large systems responsible for mental health service delivery in order to inform timing and targets for intervening.

Use big data and commensurate analytic approaches (e.g., predictive analytics, machine learning, etc.) for the purposes of understanding concentrations of risk and optimizing mental health care within the digital health ecosystem Studies that are designed to test whether digital interventions can mitigate health disparities in access, service utilization, and health outcomes.

Areas of High Program Priority Digital mental health interventions being tested should be based on existing social and behavioral science theories. Interventions should take advantage of the unique functionality of mobile and wireless devices. Utilization of real-time data collection and feedback is encouraged where appropriate.

Studies designed to test if the proposed digital mental health intervention yields significant reductions in symptoms in individuals who exhibit clinically significant symptoms and/or functional impairment at baseline. Applications that propose digital mental health interventions that focus on treating serious mental illness (SMI).

Studies that utilize software, devices, and systems that are interoperable with existing infrastructure such that resulting data is interoperable with relevant health information systems where applicable. Applications that test generalizable principles or approaches to using technology to improve the accuracy and efficiency of assessment and the effectiveness and quality of intervention and service delivery.

Studies that address known challenges with uptake and adherence/sustained use of technology-based approaches and attention to privacy and other safety/ethical considerations associated with the use of technology for research and clinical purpose. Applications that utilize digital health interventions that address health disparities or focus particularly on vulnerable populations.

Applications Not Responsive to this NOFO: The following will be considered non-responsive for this announcement and will not be reviewed: Applications that leverage mental health interventions that are not empirically based. Testing of digital mental health interventions that do not focus on reducing the severity of clinically significant mental health symptoms and/or functional impairments.

Proposed studies that do not plan to enroll participants with baseline levels of measurable clinically significant symptoms and/or functional impairment. Proposing the use of digital mental health platforms with an insufficient base of existing users to conduct rapid, appropriately powered studies. Applications that propose the translation of existing face-to-face treatments into digital health interventions.

Applications that propose clinical trials with a non-active comparator. Applications that only propose research aims associated with primary effectiveness and do not capitalize on the unique features of the proposed digital health platform.

Applications that do not include specification of intervention target(s)/mechanism(s) and assessment and analysis of intervention-induced changes in the presumed target(s)/mechanism(s) that are hypothesized to account for the intervention outcomes.

Scale and Scope of Studies Covered Under this Announcement This NOFO encourages studies that utilize well-established digital MH platforms to conduct statistically powered trials testing strategies to optimize existing evidence-based digital health interventions.

Applicants pursuing other stages of research (e.g., intervention development, pilot testing, clinical trials outside of existing well-established platforms) are encouraged to visit the Support for Clinical Trials at NIMH webpage for a list of alternative NOFOs for other stages of intervention development and testing.

Applicants are strongly encouraged to consult with NIMH staff when developing plans for an application (see Agency Contacts, Section VII ). This early contact will provide an opportunity to clarify NIMH policies and guidelines, and discuss whether the proposed project is consistent with NIMH program priorities.

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. 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. Required: Only accepting applications that propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but need to reflect the actual needs of the proposed project.

The scope of the proposed project should determine the project period. The maximum project period is 4 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) Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are 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 the 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 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 Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. 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: Factor 1.

Importance of Research Justify the practical effect of the digital mental health intervention in terms of the estimated hypothesized effect size (e.g., in terms of remediation of symptoms or functional impairment, sustained skill use, improved adherence), compared with already available approaches.

Address the potential impact of the digital mental health intervention in terms of both (1) the empirical basis for the anticipated effect size (e.g., citing data regarding the magnitude of the association between the target and the clinical endpoint of interest and/or effect sizes obtained in prior efficacy studies), and (2) the clinical meaningfulness of the anticipated increment in effects compared to existing approaches.

Address the degree to which the proposed digital mental health intervention is scalable and could be disseminated into practice, given typically available resources (e.g., trained, skilled providers), typical service structures (including mental health care financing), and typical service use patterns.

Detail how the proposed research will generate data that will lead to a firm conclusion about the digital mental health intervention and provide information about the anticipated scope and goals of intended future work.

Highlight how innovative research strategies and design/analytic elements are incorporated, as appropriate, to enhance the study's potential for yielding practice-relevant information, and enable the research to be conducted within a rapid time frame.

Highlight how the digital health platform capitalizes on the unique functionality of mobile and wireless devices, utilizes real-time data collection, incorporates regular software updates that are informed by the research and user feedback.

Highlight how the research will leverage mobile health and health information technology (smartphones, wearable sensors, internet platforms, and electronic health records) with biological, social, and behavioral data. Factor 2.

Rigor and Feasibility Detail the rationale and empirical basis for the digital mental health intervention approach in terms of the intended target population, stage of intervention (e.g., acute care, continuation or maintenance treatment, transition to independent care management), corresponding goals and focus of the intervention (e.g., remediating symptoms or impairments; promoting sustained adherence), potential scalability, key window or timeframe over which the digital mental health intervention should be administered.

Consistent with NIMH's experimental therapeutics approach, include a plan that explicitly addresses whether the digital mental health intervention engages the mechanism that is presumed to underlie the intervention effects (the mechanism that accounts for changes in clinical/ functional outcomes, changes in patient or provider behavior, etc.).

Specifically, include a conceptual framework that clearly identifies the target mechanisms and the empirical evidence linking the mechanisms to the study outcomes, plans for assessing engagement of the target mechanisms, and analytic strategies that will examine target engagement and associations with clinical benefit.

In the case of multi-component interventions, the application should specify the conceptual basis, assessment plan, and analytic strategy for the target mechanisms corresponding to each intervention component, as appropriate in the effectiveness context.

Clearly describe the proposed digital health platform including a clear description of the digital health intervention, the number of currently active daily users, and the necessary infrastructure to remotely administer and record assessments. Provide an enrollment plan that documents how current users will be recruited, consented and randomized. Ensure the enrollment plan aligns with the proposed sample size and power analysis .

Describe the assessment and monitoring of the fidelity of intervention delivery via procedures that are feasible and valid. Include outcome measures that are validated and generally accepted by the field, including stakeholder-relevant outcomes (e.g., individual functioning, health services use), as appropriate.

Justify the proposed period of observation (i.e., timing of assessments and length of follow-up), given the intent of the intervention (e.g., acute care, continuation therapy, skill generalization, maintenance of gains, adherence promotion). Include the assessment of symptoms and related outcomes using strategies that can facilitate sharing of data as appropriate. Factor 3.

Expertise and Resources Describe plans to involve collaborations and/or input from community practice partners/providers, consumers, and relevant policy makers in a manner that informs the research (e.g., to help ensure the interventions/service delivery approaches are acceptable, feasible, and scalable) and helps to ensure the results will have utility for end-users.

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.

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 under this FOA are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-19-033 ).

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 FOA 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 web site provides two tools to help investigators develop appropriate strategies: 1) the 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 FOA prior to submission to NDA and review their