Opportunity Information: Apply for RFA MH 16 410
Apply for RFA MH 16 410
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants.
- This funding opportunity was created on Mar 30, 2015 and posted on Mar 30, 2015.
- Applicants must submit their applications by Oct 14, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $225,000.00 in funding.
- The number of recipients for this funding is limited to 4,000,000 candidate(s).
- Eligible applicants include: City or township governments State governments Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education For profit organizations other than small businesses Native American tribal governments (Federally recognized) Independent school districts.
- 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.
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Opportunity Summary:
The Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34) funding opportunity (RFA-MH-16-410) was a National Institutes of Health grant announcement issued through the National Institute of Mental Health (NIMH) to support early-stage, real-world oriented intervention research in mental health. It focused on pilot trials that help investigators bridge the gap between interventions that already work under controlled conditions and interventions that can succeed in typical community and service settings. The central idea was to fund the kind of careful, practical pilot work that makes a later, larger, definitive effectiveness or services trial possible and competitive.
The FOA emphasized two main project types. First, it encouraged effectiveness research on preventive and therapeutic interventions that have previously demonstrated efficacy, but now need to be tested with broader populations or in routine practice environments (for example, community clinics, schools, justice settings, primary care, or other usual-care contexts). Second, it supported the development and preliminary testing of innovative services interventions, meaning interventions aimed at improving how mental health services are organized, delivered, accessed, or sustained, rather than only testing a clinical treatment protocol itself.
A key expectation was that applicants would use the pilot phase to generate strong preliminary evidence about whether an approach is feasible and workable in the intended setting. Projects were expected to evaluate feasibility (can it be implemented as planned), tolerability and acceptability (will patients, providers, and systems use it and stick with it), and safety (particularly important when scaling into less controlled environments). The FOA also highlighted the importance of producing preliminary data that can justify and inform a subsequent larger-scale study, such as a comparative effectiveness trial, a practical trial, or a large services research study. In other words, the R34 here functioned as a stepping-stone mechanism, supporting a smaller, targeted trial that reduces uncertainty before committing to a major multi-site investment.
NIMH signaled especially strong interest in pilot effectiveness trials that are likely to meaningfully affect practice and public health. That meant proposed work needed to be empirically grounded and clearly connected to real-world impact, not simply a small version of an efficacy study. If a team proposed adapting or augmenting an intervention that already has evidence behind it, the FOA set a high bar: changes should be made only when there is a clear empirical rationale for what is being changed, why that change matters, and what mechanism is expected to improve outcomes as a result. The announcement also stressed that pilot studies should explicitly address mechanism engagement, meaning the study design should directly test whether the intervention actually hits the target process presumed to drive improvement (for example, a hypothesized behavioral, cognitive, social, or service-delivery mechanism), rather than only reporting outcomes without examining how or why they changed.
Administratively, this was a discretionary grant opportunity in the health area, using the NIH grant funding instrument. The CFDA listing associated with the program was 93.242 (Mental Health Research Grants). The award ceiling listed in the source information was $225,000, and the opportunity stated there was no cost-sharing or matching requirement. Key dates in the listing show it was posted and created on March 30, 2015, with an original and current closing date of October 14, 2016, and an archive date of November 14, 2016, indicating the announcement is no longer active. The source data also lists an expected awards figure of 4,000,000, which appears in the opportunity record as provided.
Eligibility was broad and included many types of public and private organizations. Eligible applicants included state, county, city or township, and special district governments; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status (with the non-501(c)(3) category excluding institutions of higher education); small businesses and other for-profit organizations; and tribal entities, including federally recognized tribal governments and other tribal organizations. The eligibility information also explicitly included a range of institution types and organizations such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, Asian American and Native American Pacific Islander-serving institutions (AANAPISIs), tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and even non-U.S. (foreign) entities.
For applicants or readers who needed the full text, the announcement provided a link to the NIH grants guide posting and included NIH Office of Extramural Research (OER) webmaster contact details for access or technical issues. Overall, the opportunity was designed to fund practical, mechanism-informed pilot effectiveness and services studies that can credibly launch the next stage of large-scale testing and, ultimately, support interventions that can be delivered successfully in the settings where most people actually receive care.
Frequently Asked Questions (FAQs)
What is the Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34) opportunity?
This funding opportunity (RFA-MH-16-410) was a National Institutes of Health (NIH) grant announcement issued through the National Institute of Mental Health (NIMH). It was designed to support early-stage, real-world oriented mental health intervention research through pilot trials that help move interventions from controlled research settings into typical community and service settings.
What was the main purpose of this R34 funding opportunity?
The main purpose was to fund practical pilot work that reduces uncertainty and makes a later, larger, definitive effectiveness or services trial more feasible and competitive. The emphasis was on bridging the gap between interventions proven under controlled conditions and interventions that can succeed in routine practice.
What kinds of studies did the FOA emphasize?
The FOA emphasized two main project types:
- Pilot effectiveness research on preventive and therapeutic interventions that have already demonstrated efficacy, but need to be tested in broader populations or in routine practice settings.
- Development and preliminary testing of innovative services interventions focused on improving how mental health services are organized, delivered, accessed, or sustained (not only testing a clinical treatment protocol).
What settings were considered relevant for these pilot trials?
The opportunity highlighted routine or usual-care environments such as community clinics, schools, justice settings, primary care, and other typical service contexts where mental health care is commonly delivered.
What is meant by “effectiveness†in this context?
Here, “effectiveness†refers to testing interventions under real-world conditions, with broader populations and typical service constraints, rather than testing under tightly controlled efficacy-study conditions.
What is meant by “services interventions†in this opportunity?
Services interventions are approaches intended to improve the way mental health services function, such as how care is organized, delivered, accessed, or sustained. The focus is on improving service delivery systems and processes rather than only evaluating a treatment protocol.
What were the key expectations for what the pilot phase should produce?
The pilot phase was expected to generate strong preliminary evidence about whether the approach is feasible and workable in the intended real-world setting, and to produce data that can justify and inform a later large-scale study.
What specific outcomes or domains were projects expected to evaluate during the pilot?
Projects were expected to evaluate:
- Feasibility (whether the intervention can be implemented as planned in the setting)
- Tolerability and acceptability (whether patients, providers, and systems will use it and stick with it)
- Safety (particularly important when scaling into less controlled environments)
How was this R34 intended to connect to later-stage research?
This R34 was positioned as a stepping-stone mechanism. The idea was to support a smaller, targeted pilot trial that reduces uncertainty before a major multi-site investment, such as a comparative effectiveness trial, a practical trial, or a large services research study.
What did NIMH indicate it was especially interested in funding?
NIMH indicated especially strong interest in pilot effectiveness trials that were likely to meaningfully affect practice and public health. Proposed work needed to be empirically grounded and clearly connected to real-world impact, rather than being a smaller version of an efficacy study.
Were investigators allowed to adapt or augment an existing intervention?
Yes, but the FOA set a high bar for changes. Adaptations or augmentations were expected to be made only when there was a clear empirical rationale explaining what is being changed, why the change matters, and what mechanism is expected to improve outcomes.
What does “mechanism engagement†mean in this FOA?
Mechanism engagement refers to designing the pilot study to directly test whether the intervention affects the target process presumed to drive improvement (for example, a hypothesized behavioral, cognitive, social, or service-delivery mechanism), rather than only reporting outcomes without examining how or why they changed.
What funding agency and program area was this opportunity associated with?
The opportunity was issued by NIH through NIMH and was associated with the CFDA listing 93.242 (Mental Health Research Grants).
What type of grant instrument was used?
The listing describes it as an NIH grant funding instrument under a discretionary grant opportunity in the health area.
What was the award ceiling listed for this opportunity?
The award ceiling listed in the source information was $225,000.
Was cost-sharing or matching required?
No. The opportunity stated there was no cost-sharing or matching requirement.
What were the key posted and closing dates for this announcement?
Key dates in the listing show it was posted/created on March 30, 2015, with an original and current closing date of October 14, 2016.
Is this funding opportunity still active?
No. The archive date listed was November 14, 2016, indicating the announcement is no longer active.
What did the source record list for expected awards?
The source data lists an expected awards figure of 4,000,000 as it appears in the opportunity record provided.
Who was eligible to apply?
Eligibility was broad and included many public and private organization types, including:
- State, county, city or township, and special district governments
- Independent school districts
- Public housing authorities/Indian housing authorities
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Nonprofits with or without 501(c)(3) status (with the non-501(c)(3) category excluding institutions of higher education)
- Small businesses and other for-profit organizations
- Tribal entities, including federally recognized tribal governments and other tribal organizations
Did the eligibility language include specific institution categories like minority-serving institutions?
Yes. The eligibility information explicitly included institution and organization types such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, Asian American and Native American Pacific Islander-serving institutions (AANAPISIs), and tribally controlled colleges and universities (TCCUs).
Were faith-based and community-based organizations included as eligible applicants?
Yes. The eligibility description explicitly included faith-based or community-based organizations.
Could federal agencies apply?
Yes. The eligibility information included eligible federal agencies.
Were U.S. territories or possessions included?
Yes. The eligibility listing included U.S. territories or possessions and regional organizations.
Were non-U.S. (foreign) entities eligible?
Yes. The eligibility information stated that non-U.S. (foreign) entities were included.
Where could applicants find the full announcement text?
The announcement provided a link to the NIH grants guide posting for the full text.
Who was listed as a contact for access or technical issues?
The opportunity included NIH Office of Extramural Research (OER) webmaster contact details for access or technical issues.
In one sentence, what was this opportunity trying to accomplish?
It was designed to fund practical, mechanism-informed pilot effectiveness and services studies that can credibly launch the next stage of large-scale testing and ultimately support interventions that work in the settings where most people actually receive care.
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