The National Institute of Mental Health (NIMH) is offering this R01 grant to support clinical trials for mental health interventions. This grant is for testing the effectiveness of optimized therapeutic and preventive interventions in community and practice settings. It also aims to evaluate patient-, provider-, organizational-, or systems-level services interventions to enhance access, continuity, quality, equity, and value of mental health services. Supported trials must address significant problems, be adequately powered with strong hypotheses, and examine mediators/moderators of effects. Consistent with NIMH’s experimental therapeutics approach, proposals should explicitly address how interventions engage their presumed underlying mechanisms. The collaborative R01 mechanism supports multisite trials when necessary for increasing sample size, accelerating recruitment, or improving sample diversity.
Opportunity ID: 357421
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-177 |
| Funding Opportunity Title: | Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 – Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 27, 2024 |
| Last Updated Date: | Nov 27, 2024 |
| Original Closing Date for Applications: | Oct 15, 2027 |
| Current Closing Date for Applications: | Oct 15, 2027 |
| Archive Date: | Nov 20, 2027 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses City or township governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Independent school districts |
| Additional Information on 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | 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). |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-177.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 357421 Full Announcement-PAR-25-177 -> PAR-25-177-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289142 | Jan 14, 2025 | Oct 15, 2027 | View |
Package 1
Mandatory forms
357421 RR_SF424_5_0-5.0.pdf
357421 PHS398_CoverPageSupplement_5_0-5.0.pdf
357421 RR_OtherProjectInfo_1_4-1.4.pdf
357421 PerformanceSite_4_0-4.0.pdf
357421 RR_KeyPersonExpanded_4_0-4.0.pdf
357421 PHS398_ResearchPlan_5_0-5.0.pdf
357421 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357421 RR_Budget_3_0-3.0.pdf
357421 RR_SubawardBudget30_3_0-3.0.pdf
357421 PHS398_ModularBudget_1_2-1.2.pdf
357421 PHS_AssignmentRequestForm_4_0-4.0.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
