This department is offering a grant to conduct confirmatory efficacy testing of non-pharmacological therapeutic interventions for mental disorders in adults and children. Trials must provide valuable scientific information to support further development or dissemination of interventions. Eligible interventions include behavioral, cognitive, interpersonal, and device-based approaches, among others. Proposed studies should be scientifically justified, show engagement with the hypothesized mechanism of action, display preliminary efficacy, and address unmet therapeutic needs. Funding will be given to trials that measure the intervention’s efficacy, mechanism of action, and its impact on functional or clinical outcomes to assess potential clinical benefit.
Opportunity ID: 275514
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-MH-16-425 |
| Funding Opportunity Title: | Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 4 |
| Assistance Listings: | 93.242 — Mental Health Research Grants |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Mar 30, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Oct 14, 2016 |
| Current Closing Date for Applications: | Oct 14, 2016 |
| Archive Date: | Nov 14, 2016 |
| Estimated Total Program Funding: | $4,000,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Small businesses Special district governments City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities |
| 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: | The purpose of this Funding Opportunity Announcement (FOA) is to support confirmatory efficacy testing of non-pharmacological therapeutic and preventive interventions for mental disorders in adults and children through an experimental therapeutics approach. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support “go/no-go” decisions about further development, effectiveness testing, or dissemination of the intervention. Intervention studies include, but are not limited to behavioral, cognitive, interpersonal, and device-based approaches, or a combination thereof. Interventions appropriate for efficacy testing must be based on a compelling scientific rationale, previous demonstration that the intervention engages and alters the hypothesized mechanism of action, a preliminary efficacy signal, and must address an unmet therapeutic need. Support will be provided for a trial of the intervention’s efficacy that includes measurement of the hypothesized mechanism of action and the relationship between change in the mechanism and change in functional or clinical effects. Ultimately, this FOA is intended to support a sufficiently- powered efficacy trial to determine the intervention’s potential for significant clinical benefit. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-16-425.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-C | FORMS-C | PKG00215860 | May 15, 2015 | Apr 07, 2016 | View | |
| FORMS-D | Use for due dates on or after May 25, 2016 | PKG00222413 | May 15, 2016 | Oct 14, 2016 | View |
Package 1
Mandatory forms
275514 RR_SF424_2_0-2.0.pdf
275514 PHS398_ResearchPlan_2_0-2.0.pdf
275514 PHS398_CoverPageSupplement_2_0-2.0.pdf
275514 RR_KeyPersonExpanded_2_0-2.0.pdf
275514 RR_OtherProjectInfo_1_3-1.3.pdf
275514 PerformanceSite_2_0-2.0.pdf
Optional forms
275514 RR_SubawardBudget30_1_3-1.3.pdf
275514 PlannedReport-1.0.pdf
275514 PHS398_CumulativeInclusionReport-1.0.pdf
275514 PHS398_ModularBudget_1_2-1.2.pdf
275514 RR_Budget_1_3-1.3.pdf
Package 2
Mandatory forms
275514 RR_SF424_2_0-2.0.pdf
275514 PHS398_CoverPageSupplement_3_0-3.0.pdf
275514 RR_OtherProjectInfo_1_3-1.3.pdf
275514 PerformanceSite_2_0-2.0.pdf
275514 RR_KeyPersonExpanded_2_0-2.0.pdf
275514 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
275514 RR_Budget_1_3-1.3.pdf
275514 RR_SubawardBudget30_1_3-1.3.pdf
275514 PHS398_ModularBudget_1_2-1.2.pdf
275514 PHS_Inclusion_Enrollment_Report-1.0.pdf
275514 PHS_AssignmentRequestForm-1.0.pdf
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