Opportunity Information: Apply for PAR 18 431
The National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), offered this grant opportunity to support pilot effectiveness clinical trials focused on the post-acute phase of mental health care. The core idea is to test intervention approaches that come after an initial acute treatment period, when a person may have stabilized but still faces meaningful risks like symptom return, functional impairment, relapse, poor treatment adherence, or inconsistent engagement with services. NIMH is looking for projects that match the intervention to the stage of illness, both in what the intervention targets (for example, maintaining treatment gains, addressing residual symptoms, preventing relapse, promoting adherence, and guiding appropriate service use) and in the level of intensity or burden placed on participants and service systems.
This opportunity uses the R34 mechanism and requires clinical trials. In practical terms, it is meant for early-stage effectiveness testing in real-world or clinically relevant service settings, not for a fully powered definitive trial. Applications are expected to propose a pilot effectiveness study that can show whether the intervention is workable and promising enough to justify a larger, more expensive, and more definitive effectiveness trial later. The pilot trial is expected to generate concrete, decision-quality evidence about whether to move forward, what refinements are needed, and how a later larger trial should be designed.
The main outcomes NIMH emphasizes for this pilot phase include feasibility (can the study and intervention be delivered as planned in the intended setting), tolerability (can participants realistically stay with the intervention), acceptability (do participants and providers find it appropriate and usable), and safety (monitoring risks and adverse events in a structured way). Beyond these implementation-focused outcomes, the project should also provide preliminary indications of effectiveness on longer-term post-acute outcomes and should assess whether the intervention actually engages its intended targets or mechanisms. In other words, NIMH is not only asking, "Does it look like it helps?" but also, "Is it operating through the change processes it claims to affect?" and "Do we have enough evidence to justify a larger trial?"
A key expectation is that the pilot will produce the kind of preliminary data needed as a prerequisite for a subsequent fully powered effectiveness trial, such as a comparative effectiveness study or a practical trial. That includes information like recruitment and retention rates, adherence to intervention delivery, estimates of effect size and variability for planning sample size, clarity on outcome measurement timing, and lessons learned about implementation challenges in the targeted settings. The funding announcement also makes a clear boundary: it is not intended to pay for a definitive, fully powered effectiveness study. NIMH points applicants who are ready for that stage to a separate R01 opportunity (PAR-18-423) focused on fully powered post-acute effectiveness studies.
In terms of who can apply, eligibility is broad and includes many types of domestic U.S. organizations and governments: state, county, city/township, special district governments, independent school districts, public and state-controlled universities, private institutions of higher education, federally recognized Native American tribal governments, tribal organizations (including those other than federally recognized), public housing authorities/Indian housing authorities, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses. The announcement also explicitly highlights additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs). Faith-based and community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations) are also included, reflecting NIMH's interest in diverse settings and applicant types that can realistically study post-acute care.
Administratively, the opportunity is identified as PAR 18-431 under the NIH/NIMH umbrella, categorized as a discretionary grant in the health area, with CFDA number 93.242. The listed award ceiling is $225,000 (as provided in the source data). The original closing date shown is January 7, 2021, and the opportunity was created December 6, 2017. Overall, the program is best understood as a bridge between early intervention development and later definitive effectiveness testing: it funds rigorous pilot clinical trials of post-acute interventions and service delivery strategies so investigators can determine whether an approach is feasible, safe, acceptable, and sufficiently promising, while also generating the planning data needed for a subsequent large-scale effectiveness trial aimed at improving longer-term outcomes after acute mental health treatment.Apply for PAR 18 431
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pilot Effectiveness Trials for Post-Acute Interventions and Serivces to Optimize Longer-Term Outcomes (R34-Clinical Trials Required)" 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 2017-12-06.
- Applicants must submit their applications by 2021-01-07. (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.
- 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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Frequently Asked Questions (FAQs)
What is this NIMH/NIH grant opportunity about?
This opportunity from the National Institute of Mental Health (NIMH), within the National Institutes of Health (NIH), supports pilot effectiveness clinical trials focused on the post-acute phase of mental health care. The emphasis is on testing intervention approaches delivered after an initial acute treatment period, when an individual may be more stable but still faces important ongoing risks.
What does "post-acute" mean in the context of this program?
"Post-acute" refers to the period after an initial acute treatment phase. Even after stabilization, people can still experience risks such as symptom return, functional impairment, relapse, poor treatment adherence, or inconsistent engagement with services. This program targets interventions designed for that stage.
What types of risks and outcomes is NIMH concerned about in the post-acute phase?
NIMH highlights ongoing risks that can occur after acute treatment, including symptom return, functional impairment, relapse, poor adherence to treatment, and inconsistent engagement with services. The grant supports interventions aimed at reducing these risks and improving longer-term outcomes.
What kinds of interventions are appropriate for this opportunity?
Projects should propose post-acute intervention approaches that align with the stage of illness. Examples of appropriate targets include maintaining treatment gains, addressing residual symptoms, preventing relapse, promoting adherence, and guiding appropriate service use. NIMH also expects the intervention intensity and burden to be appropriate for participants and service systems.
What does it mean to "match the intervention to the stage of illness"?
It means the intervention should be designed for post-acute needs and realities. That includes (1) targeting issues relevant to the post-acute period (such as relapse prevention or sustaining gains) and (2) calibrating the level of intensity, complexity, and burden so it fits real-world service settings and is realistic for participants and providers.
What funding mechanism does this opportunity use?
This opportunity uses the NIH R34 mechanism.
Are clinical trials required?
Yes. The opportunity requires clinical trials.
Is this meant to fund a large, definitive effectiveness trial?
No. The announcement makes a clear boundary that it is not intended to pay for a definitive, fully powered effectiveness study. It is intended for early-stage effectiveness testing to determine whether a larger, more expensive, and more definitive effectiveness trial is justified.
What is the main purpose of the pilot effectiveness trial supported by this grant?
The purpose is to generate decision-quality evidence on whether the intervention is workable and promising enough to justify a later, fully powered effectiveness trial. The pilot is expected to inform go/no-go decisions, refinements to the intervention and study procedures, and the design of a subsequent larger trial.
What settings does NIMH expect these pilot trials to occur in?
The program is intended for real-world or clinically relevant service settings. The goal is early-stage effectiveness testing in settings that reflect how post-acute care is actually delivered, rather than tightly controlled conditions aimed at a definitive trial.
What outcomes does NIMH emphasize for the pilot phase?
NIMH emphasizes four core pilot outcomes:
- Feasibility: whether the study and intervention can be delivered as planned in the intended setting
- Tolerability: whether participants can realistically stay with the intervention
- Acceptability: whether participants and providers find the intervention appropriate and usable
- Safety: monitoring risks and adverse events in a structured way
Does the pilot need to measure clinical effectiveness outcomes too?
Yes, in addition to feasibility, tolerability, acceptability, and safety, the project should provide preliminary indications of effectiveness on longer-term post-acute outcomes.
What does NIMH mean by testing targets or mechanisms of change?
NIMH is not only asking whether the intervention appears to help, but also whether it engages its intended targets or mechanisms. In practical terms, the study should assess whether the intervention is operating through the change processes it claims to affect, alongside preliminary outcome signals.
What kinds of planning data should this pilot generate for a later fully powered trial?
The pilot is expected to produce preliminary data typically needed before launching a larger effectiveness trial, including:
- Recruitment and retention rates
- Adherence to intervention delivery
- Estimates of effect size and variability to support sample size planning
- Clarity on outcome measurement timing
- Lessons learned about implementation challenges in targeted service settings
If an applicant is ready for a fully powered effectiveness trial, what should they do instead?
The announcement points applicants who are ready for a definitive, fully powered post-acute effectiveness study to a separate R01 opportunity: PAR-18-423.
Who is eligible to apply for this grant?
Eligibility is broad. The opportunity includes many types of domestic U.S. organizations and governments, and also includes non-U.S. entities (foreign organizations). Eligible applicants listed include:
- State, county, and city/township governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Tribal organizations (including those other than federally recognized)
- Public housing authorities/Indian housing authorities
- Nonprofits (with or without 501(c)(3) status)
- For-profit organizations (other than small businesses)
- Small businesses
- Eligible federal agencies
- Regional organizations
- U.S. territories or possessions
- Non-U.S. entities (foreign organizations)
- Faith-based and community-based organizations
Are specific institution types explicitly encouraged or highlighted as eligible?
Yes. The announcement explicitly highlights additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs).
What is the opportunity identification number?
The opportunity is identified as PAR 18-431.
What is the CFDA number listed for this opportunity?
The listed CFDA number is 93.242.
What is the award ceiling listed for this opportunity?
The listed award ceiling is $225,000 (as provided in the source data).
What was the original closing date shown for this opportunity?
The original closing date shown is January 7, 2021.
When was this opportunity created?
The opportunity was created on December 6, 2017.
How should this program be understood in the overall research pipeline?
This program functions as a bridge between earlier intervention development and later definitive effectiveness testing. It funds rigorous pilot clinical trials of post-acute interventions and service delivery strategies to determine whether an approach is feasible, safe, acceptable, and promising, while generating the planning data needed for a subsequent large-scale effectiveness trial.
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