Pilot Effectiveness Trials for Post-Acute Interventions and Serivces to Optimize Longer-Term Outcomes (R34-Clinical Trials Required) | PAR 18 431

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.

• 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.

Apply for PAR 18 431

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