Optimizing Behavioral Sleep Interventions for Adolescents and Young Adults (R34 Clinical Trial Required)

The National Institutes of Health (NIH), specifically the National Institute of Mental Health (NIMH), has announced a new funding opportunity under the activity code R34 Planning Grant. This grant, titled "Optimizing Behavioral Sleep Interventions for Adolescents and Young Adults," is intended to support pilot research that adapts, optimizes, and tests empirically supported behavioral interventions targeting sleep problems in youth aged 12 to 25 who are experiencing or at risk for mental health disorders. The focus of the grant is to evaluate the feasibility, acceptability, safety, and potential effectiveness of these interventions within real-world settings, laying the groundwork for future large-scale effectiveness trials. The grant aims to address the growing concern of sleep-related issues in adolescents and young adults, particularly among underserved populations such as those from lower socioeconomic backgrounds. These sleep problems are recognized by leading health organizations as a public health crisis due to their implications for mental health. The initiative emphasizes scalable, developmentally appropriate interventions that reflect the social and behavioral context of youth today, including digital device usage and environmental challenges. Eligible applicants include a broad array of entities, such as higher education institutions, nonprofit organizations, for-profit organizations, and various levels of government, including tribal and regional authorities. Both U.S.-based and foreign organizations may apply. Each application must involve a clinical trial and should integrate assessments of sleep and mental health outcomes. Additionally, applicants are encouraged to include mechanisms of intervention impact, stakeholder involvement (e.g., youth advisory panels), and considerations for disparities in sleep and mental health outcomes. The grant supports a total of up to $1.5 million for FY 2025, funding up to six awards. Each award can request no more than $225,000 in direct costs per year, with a total cap of $450,000 over a maximum project period of three years. Applications are due on October 30, 2024, and June 13, 2025, depending on the cycle. Letters of intent are recommended and due 30 days before the application due date. Applications must comply with NIH’s standard submission procedures via systems such as NIH ASSIST or Grants.gov. Extensive instructions for application preparation and submission are provided, including guidance on data sharing, suicide-related outcomes assessments, and human subject protections. Applicants are expected to include a Data Management and Sharing Plan with plans for submission of data to the NIMH Data Archive. For questions, applicants can contact Mary Rooney, Ph.D. (Scientific/Research), Nicholas Gaiano, Ph.D. (Peer Review), or Tamara Kees (Financial/Grants Management) at the National Institute of Mental Health. Their emails are mary.rooney@nih.gov, nick.gaiano@nih.gov, and tamara.kees@nih.gov, respectively.