Optimizing Behavioral Sleep Interventions for Adolescents and Young Adults (R34 Clinical Trial Required) | RFA MH 25 130

Opportunity Information: Apply for RFA MH 25 130

The National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), is soliciting applications for an R34 pilot clinical trial grant titled "Optimizing Behavioral Sleep Interventions for Adolescents and Young Adults (R34 Clinical Trial Required)" (Funding Opportunity Number RFA-MH-25-130; CFDA 93.242). The overall goal is to support early-stage, real-world pilot research that adapts, optimizes, and tests behavioral sleep interventions that already have empirical support, with a specific focus on adolescents and young adults who have, or are at risk for, a mental health disorder. In practical terms, this opportunity is designed to help teams take interventions that work in controlled research environments and refine them so they can be delivered effectively in the settings where young people actually receive care or support.

Projects are expected to go beyond simply delivering a program and measuring outcomes. NIMH is looking for pilot trials that systematically evaluate feasibility (can the intervention be delivered as intended in the intended setting), tolerability (is the burden manageable for youth), acceptability (do participants and stakeholders find it appropriate and worth using), and safety (including monitoring for any adverse effects). Applicants are also expected to generate early signals of potential effectiveness, which usually means collecting preliminary outcome data that can indicate whether the approach is promising enough to justify a larger, more definitive trial later. Because this is an R34, the intent is explicitly developmental: to produce the foundational evidence and practical know-how needed before launching a larger-scale effectiveness study.

A key feature of the announcement is its emphasis on mechanisms and measurement. NIMH encourages applicants to include a preliminary test of how the intervention affects target mechanisms (the processes the intervention is supposed to change) as well as sleep outcomes and mental health outcomes. That means proposals should typically articulate a clear theory of change linking intervention components to sleep-related mechanisms (for example, behavioral routines, arousal regulation, circadian-related behaviors, or cognitive/behavioral factors depending on the intervention) and then to downstream impacts on sleep and mental health. The pilot work should yield usable preliminary data, not only to show initial promise but also to refine procedures, outcome measures, recruitment and retention strategies, and implementation approaches that will be needed as prerequisites for a later, larger effectiveness trial.

Another major priority is equity and reach. NIMH places special emphasis on studies that address the needs of youth from understudied and underserved populations. Applicants would be expected to think carefully about barriers to access and engagement, cultural and contextual fit, and the realities of delivering behavioral sleep interventions in diverse communities. This could influence choices about intervention format (for example, in-person vs. digital or hybrid delivery), staffing and training models, language accessibility, community partnership, and recruitment strategies designed to include populations that are often missing from sleep and mental health intervention research.

The opportunity is open to a wide range of applicant organizations. Eligible applicants include various levels of government (state, county, city/township, and special district governments), independent school districts, public housing authorities/Indian housing authorities, tribal governments (federally recognized) and other tribal organizations, public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), and small businesses. The announcement also explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This broad eligibility signals that NIMH is interested in pilots that can be embedded in many different real-world contexts, including community-based and culturally specific settings.

Administratively, this is a discretionary grant mechanism under NIH, with an original application due date listed as June 13, 2025, and an opportunity record created on April 17, 2024. While the excerpt provided does not list an award ceiling or the expected number of awards, the core intent is clear: fund pilot clinical trials that refine and test behavioral sleep interventions for youth mental health populations, generate early evidence on implementation and outcomes, and produce the preliminary foundation necessary to move toward a larger, more definitive effectiveness trial.

• 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 2024-04-17.
• Applicants must submit their applications by 2025-06-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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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