Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 - Clinical Trial Required)
Open Posted
- Opportunity number
- PAR-25-177
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Category
-
- Health
- Eligible applicants
-
- Higher Education Inst. (Public)
- Non-501(c)(3) Nonprofits
- Small Businesses
- County Governments
- Public or Indian Housing Auth.
- Special District Governments
- Tribal Governments (Federally Recognized)
- Independent School Districts
- Other
- For Profit Organizations
- Tribal Organizations (Not Federally Recognized)
- Higher Education Inst. (Private)
- City/Township Governments
- 501(c)(3) Nonprofits
- State Governments
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institute of Mental Health (NIMH) is soliciting applications for full-scale hybrid effectiveness-implementation trials testing mental health interventions under the R01 mechanism, with an application due date of October 15, 2027. This NOFO supports clinical trials evaluating either therapeutic and preventive interventions in community and practice settings or patient-, provider-, organizational-, or systems-level services interventions to improve access, continuity, quality, equity, and value of mental health services. The collaborative R01 mechanism explicitly covers multisite trials when two or more sites are necessary for sample size, recruitment acceleration, or sample diversity.
Eligible applicants include higher education institutions (public and private), 501(c)(3) and non-501(c)(3) nonprofits, small businesses, for-profit organizations, state and local governments, county governments, city and township governments, tribal governments (federally recognized and not federally recognized), tribal organizations, special district governments, independent school districts, public or Indian housing authorities, Alaska Native and Native Hawaiian serving institutions, HBCUs, Hispanic-serving institutions, AANAPISIs, TCCUs, faith-based and community-based organizations, regional organizations, eligible federal agencies, non-domestic entities, and U.S. territories or possessions.
Proposals must address significant problems with potential to inform practice, demonstrate adequate statistical power supported by pilot data with well-justified hypotheses, and examine mediators and moderators of effects. Consistent with NIMH's experimental therapeutics approach, trials must explicitly address whether interventions engage their presumed underlying mechanisms of action. Award decisions reflect scientific and technical merit, program relevance, and program balance. The program operates under CFDA 93.242 (Mental Health Research Grants). Support extends to a maximum of five years per project period, with prior renewal as a competing request.
Synopsis
Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required). This NOFO is a key element of NIMHs set of NOFOs to support clinical trials research across the intervention development and testing pipeline. The NOFO supports (1) clinical trials to test the effectiveness of optimized therapeutic and preventive interventions for use in community and practice settings; and (2) clinical trials to evaluate the effectiveness of patient-, provider-, organizational-, or systems-level services interventions to improve access, continuity, quality, equity, and/or value of mental health services. This NOFO is intended to support trials that: address a significant problem, such that the findings have potential to inform practice; are adequately powered to definitively answer the primary research question(s), with well-justified hypotheses supported by pilot data; and are designed to examine questions regarding mediators and moderators of effects. Consistent with the NIMH experimental therapeutics approach, this NOFO is intended to support effectiveness trials that explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects (i.e., the mechanism(s) that accounts for changes in clinical/functional outcomes, changes in provider behavior, improved access or continuity of services, etc.). The collaborative R01 mechanism provides support for multisite trials when two or more sites are necessary for completion of the trial (e.g., to increase sample size, accelerate recruitment, or increase sample diversity and representation).
Eligibility
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-177-Full-Announcement.html | HTML file | |
| PKG00289142.pdf |
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