Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R34 Clinical Trial Optional)

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites applications for planning grants under the R34 mechanism to advance prevention and intervention strategies for Fetal Alcohol Spectrum Disorders (FASD). This initiative aims to address prenatal alcohol exposure and its consequences across the lifespan through novel or enhanced methods. Research funded under this opportunity should generate pilot and feasibility data essential for preparing larger-scale studies (e.g., R01) aimed at reducing prenatal alcohol exposure, lowering FASD incidence, and improving outcomes for affected individuals. Eligible research may focus on novel prevention strategies or interventions informed by basic science findings, scalable approaches to increase community impact, or multicomponent interventions designed to mitigate FASD-related deficits. Studies should include a theory of change or logic model, with clearly defined hypotheses. Examples of responsive projects include cost-effective, culturally sensitive community interventions, scalable health messaging strategies to reduce alcohol use in pregnancy, and innovative therapeutic approaches to address neurocognitive and behavioral deficits. Proposals may also target interventions for high-risk or vulnerable populations, improve FASD care models, or integrate FASD-specific strategies into broader developmental disability networks. Funding for R34 grants allows for up to $450,000 in direct costs over three years, with no more than $225,000 allowed in a single year. Applications may include clinical trials but are not required to do so. Projects focusing on HIV/AIDS-related topics, animal studies, or non-responsive research areas will not be considered. While preliminary data is not mandatory, applicants must demonstrate sufficient institutional support, resources, and experience to undertake the proposed research. Eligible applicants include higher education institutions, nonprofits, small businesses, local governments, and foreign organizations. The initiative encourages the inclusion of diverse populations and community-based collaborations to ensure broad relevance and equity. Foreign organizations and non-domestic components of U.S. institutions are eligible. Key deadlines include a letter of intent 30 days before the application due date, with submissions open from January 16, 2025, to January 8, 2027. Review criteria emphasize the significance, innovation, and feasibility of the proposed research, along with the expertise and resources of the investigator team. Strong applications will detail plans for data sharing in compliance with NIH and NIAAA guidelines, including information on study populations, alcohol exposure paradigms, and relevant data standards. For questions regarding program fit or application requirements, applicants are encouraged to consult with the designated NIAAA program officers. Further information on submission guidelines, peer review criteria, and post-award requirements is detailed in the funding announcement.