Opportunity Information: Apply for RFA MH 27 140
The National Institute of Mental Health (NIMH), within the National Institutes of Health (NIH), is offering an R34 pilot clinical trial grant opportunity focused on improving behavioral sleep interventions for adolescents and young adults who have, or are at risk for, a mental health disorder. The core goal is to support early-stage, real-world research that adapts existing behavioral approaches or develops optimized versions of them to address common sleep problems in these age groups, while also examining how changes in sleep may relate to changes in mental health outcomes. This funding opportunity is positioned as a stepping-stone: it is meant to generate the practical and scientific groundwork needed before launching larger, more definitive effectiveness trials.
The program specifically supports pilot clinical trials (clinical trial required) that test whether a proposed sleep-focused behavioral intervention can be delivered successfully in settings that reflect real practice conditions. Applicants are expected to evaluate key “can this work in the real world?” outcomes, including feasibility (whether the study and intervention procedures can be carried out as planned), tolerability (whether participants can comfortably engage with the intervention), acceptability (whether participants and stakeholders view the intervention as appropriate and worthwhile), and safety (whether any adverse outcomes occur). Alongside these implementation-oriented outcomes, the NOFO emphasizes gathering early evidence of potential effectiveness, meaning applicants should include preliminary tests of whether the intervention improves sleep and whether it shows promise for improving mental health symptoms, functioning, or related clinical outcomes relevant to the target population.
A major scientific expectation is that projects do more than simply measure pre-post change. Applications are encouraged to examine mechanisms of action, such as identifying the processes through which the intervention is thought to work (for example, changes in circadian timing, reductions in pre-sleep arousal, improvements in sleep regularity, altered reward or emotion regulation processes, or other plausible behavioral and psychophysiological pathways). In practice, this means applicants should propose measurement strategies and analytic plans that can plausibly test mechanistic hypotheses in a pilot context, producing preliminary data that will directly strengthen a future larger-scale trial application.
The NOFO also signals strong interest in interdisciplinary and collaborative research teams. NIMH explicitly encourages teams that combine expertise across mental health and sleep medicine with developmental science, clinical trial methods, behavioral economics, implementation science, data science, and human-computer interaction. This emphasis reflects the reality that adolescent and young adult sleep interventions often intersect with technology, engagement challenges, school or work schedules, family systems, and barriers to sustained behavior change, so projects that integrate design, implementation, and analytic expertise are aligned with the intent of the announcement.
In terms of logistics and eligibility, this is a discretionary grant in the health category (CFDA 93.242), with an estimated six awards expected. The opportunity is identified as RFA-MH-27-140, and the listed closing date is October 22, 2026. A wide range of U.S.-based applicant organizations are eligible, including state and local governments, tribes and tribal organizations, public and private institutions of higher education, independent school districts, certain housing authorities, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), and other eligible entities described in the NOFO. However, international involvement is tightly restricted: non-U.S. organizations cannot apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.
Overall, this opportunity is aimed at projects that can credibly demonstrate an intervention is ready to move toward a larger effectiveness stage by showing it can be delivered safely and acceptably, produces promising signals on sleep and mental health outcomes, and yields interpretable early evidence about why and how it works in adolescents and young adults in real-world contexts.Apply for RFA MH 27 140
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Optimizing Behavioral Sleep Interventions for Adolescents and Young Adults (R34 Clinical Trial 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 2026-05-28.
- Applicants must submit their applications by 2026-10-22. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 6 candidate(s).
- 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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FAQs: NIMH/NIH R34 Pilot Clinical Trial - Behavioral Sleep Interventions for Adolescents and Young Adults (RFA-MH-27-140)
What is this funding opportunity?
This is a National Institute of Mental Health (NIMH), National Institutes of Health (NIH) R34 pilot clinical trial grant opportunity (RFA-MH-27-140) focused on improving behavioral sleep interventions for adolescents and young adults who have, or are at risk for, a mental health disorder.
What is the main goal of the program?
The core goal is to support early-stage, real-world research that adapts existing behavioral sleep approaches or develops optimized versions to address common sleep problems in adolescents and young adults, while also examining how changes in sleep may relate to changes in mental health outcomes. The program is intended as a stepping-stone to generate groundwork for later, larger effectiveness trials.
Is a clinical trial required?
Yes. The program specifically supports pilot clinical trials, and the opportunity states that a clinical trial is required.
What type of intervention is the NOFO focused on?
The focus is on sleep-focused behavioral interventions. Projects may adapt existing behavioral approaches or develop optimized versions intended to improve sleep problems in adolescents and young adults in real-world conditions.
Who is the target population?
The target population is adolescents and young adults who have, or are at risk for, a mental health disorder, and who experience common sleep problems the intervention is designed to address.
What makes this an "R34" in terms of project purpose?
As described in the opportunity, this R34 is positioned as an early-stage stepping-stone. It is meant to generate practical and scientific groundwork (including pilot data) to support a future larger, more definitive effectiveness trial.
What kinds of outcomes are applicants expected to evaluate for real-world delivery?
Applicants are expected to evaluate "can this work in the real world?" outcomes, including feasibility (whether procedures can be carried out as planned), tolerability (whether participants can comfortably engage), acceptability (whether participants and stakeholders view it as appropriate and worthwhile), and safety (whether any adverse outcomes occur).
Does the program expect preliminary evidence of effectiveness?
Yes. Alongside feasibility and other implementation-oriented outcomes, applicants are expected to gather early evidence of potential effectiveness. This includes preliminary tests of whether the intervention improves sleep and whether it shows promise for improving mental health symptoms, functioning, or other relevant clinical outcomes for the target population.
Is measuring simple pre-post change enough?
No. The opportunity highlights an expectation that projects do more than measure pre-post change. Applications are encouraged to examine mechanisms of action and propose measurement and analytic plans that can plausibly test mechanistic hypotheses in a pilot context.
What does NIMH mean by "mechanisms of action" in this context?
Mechanisms of action refer to the processes through which the sleep-focused behavioral intervention is thought to work. The opportunity provides examples such as changes in circadian timing, reductions in pre-sleep arousal, improvements in sleep regularity, and altered reward or emotion regulation processes, along with other plausible behavioral and psychophysiological pathways.
What is the expectation for mechanistic measurement and analysis in a pilot trial?
Applicants are expected to propose measurement strategies and analytic plans that can plausibly test mechanistic hypotheses in a pilot context. The intent is to generate preliminary mechanistic data that will directly strengthen a future larger-scale trial application.
What settings should the pilot clinical trials be conducted in?
The program supports trials that test whether the intervention can be delivered successfully in settings that reflect real practice conditions, rather than highly controlled environments that do not resemble real-world delivery.
How does this opportunity connect sleep outcomes to mental health outcomes?
The opportunity emphasizes examining whether improvements in sleep relate to improvements in mental health symptoms, functioning, or other clinically relevant outcomes in adolescents and young adults who have, or are at risk for, a mental health disorder.
What kind of research team does NIMH encourage?
NIMH signals strong interest in interdisciplinary and collaborative teams that combine expertise across mental health and sleep medicine with areas such as developmental science, clinical trial methods, behavioral economics, implementation science, data science, and human-computer interaction.
Why is there an emphasis on interdisciplinary collaboration?
The opportunity notes that adolescent and young adult sleep interventions often intersect with technology, engagement challenges, school or work schedules, family systems, and barriers to sustained behavior change. Integrating design, implementation, and analytic expertise is described as aligned with the intent of the announcement.
How many awards are expected?
The opportunity estimates that six awards are expected.
What is the CFDA number and category?
This is a discretionary grant in the health category with CFDA number 93.242.
What is the opportunity number and closing date?
The opportunity is identified as RFA-MH-27-140, and the listed closing date is October 22, 2026.
What types of U.S. organizations are eligible to apply?
A wide range of U.S.-based organizations are eligible, including state and local governments, tribes and tribal organizations, public and private institutions of higher education, independent school districts, certain housing authorities, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), and other eligible entities described in the NOFO.
Can non-U.S. organizations apply?
No. The opportunity states that non-U.S. organizations cannot apply.
Are non-U.S. components of U.S. organizations eligible?
No. The opportunity states that non-U.S. components of U.S. organizations are not eligible.
Are foreign components allowed under NIH policy?
No. The opportunity states that foreign components (as defined by NIH policy) are not allowed.
What is NIMH ultimately looking for at the end of an R34 pilot project?
Based on the description, NIMH is aiming for projects that can credibly demonstrate the intervention is ready to move toward a larger effectiveness stage by showing it can be delivered safely and acceptably in real-world contexts, produces promising signals on sleep and mental health outcomes, and yields interpretable early evidence about why and how it works.
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