Practice-Based Research for Implementing Scalable Evidence-Based Prevention Interventions in Primary Care Settings (R01 Clinical Trial Optional) | RFA MH 20 505

Opportunity Information: Apply for RFA MH 20 505

The National Institutes of Health (NIH) announced this discretionary grant opportunity, RFA-MH-20-505, titled "Practice-Based Research for Implementing Scalable Evidence-Based Prevention Interventions in Primary Care Settings (R01 Clinical Trial Optional)" (CFDA 93.242). It uses the R01 research project grant mechanism and is aimed at supporting practice-based research in real-world healthcare environments rather than tightly controlled, specialty research clinics. The central goal is to test how well established, theory-driven, developmentally informed prevention interventions work when they are delivered in everyday pediatric-serving primary care settings, using the kinds of staff, workflows, and resources that clinics typically have available.

The focus is on prevention interventions that can meaningfully affect mental health outcomes for children and adolescents, including reducing suicide-related behaviors and lowering risk for serious mental illness. A key requirement is that the interventions being tested are already considered efficacious (in other words, they have evidence supporting that they can work under ideal conditions). This FOA is about the next step: determining effectiveness when these interventions are implemented in routine primary care practice, where time, staffing, reimbursement constraints, and patient complexity often make implementation harder. The expectation is that applicants will design studies that speak directly to whether these approaches can be delivered at scale and sustained over time without relying on unusually intensive research infrastructure.

An important theme in the announcement is health equity. Proposed projects are expected to place emphasis on populations experiencing mental health disparities, meaning groups that face higher burdens of mental health risk, reduced access to care, and structural barriers that limit early identification and prevention. In practical terms, this points toward research that is attentive to cultural context, language access, differential barriers to engagement, and the realities of under-resourced clinics and communities. Projects should be designed so findings are relevant to diverse pediatric primary care populations and not only to well-resourced systems.

The FOA explicitly supports clinical trials, but indicates that a clinical trial is optional depending on the project design (consistent with the "Clinical Trial Optional" label). When clinical trials are proposed, they should be structured to establish effectiveness of scalable prevention interventions specifically in pediatric-serving primary care settings, and to do so using available resources in those settings. That emphasis signals a preference for pragmatic designs and implementation approaches that fit primary care operations, rather than models that depend on external specialists, extensive new staffing, or high-cost research-only supports that would be difficult for clinics to maintain after the grant ends.

Eligibility is broad and includes many types of U.S.-based organizations: state, county, and local governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other eligible entities. The announcement also highlights additional applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, Indian/Native American tribal governments other than federally recognized tribes, and U.S. territories or possessions.

At the same time, the FOA places firm limits on foreign involvement. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply. In addition, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by the NIH Grants Policy Statement are not allowed. These restrictions mean the applicant organization and the proposed work must be fully domestic in scope under NIH definitions, without foreign components.

This opportunity was created on November 25, 2019, with an original closing date listed as July 1, 2021. While the specific award ceiling and expected number of awards are not provided in the excerpted data, the overall intent is clear: fund rigorous, practice-based research that can demonstrate whether evidence-based, developmentally grounded prevention interventions can be embedded into pediatric primary care in ways that are scalable, sustainable, and effective, especially for communities facing mental health inequities.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Practice-Based Research for Implementing Scalable Evidence-Based Prevention Interventions in Primary Care Settings (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
• This funding opportunity was created on 2019-11-25.
• Applicants must submit their applications by 2021-07-01. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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