NIH – Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD), Research Project (U01 Clinical Trial optional)

June 11, 2021 by


The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks applications to continue the previously funded “Collaborative Initiative on Fetal Alcohol Spectrum Disorders” (CIFASD). Responsive applications are expected to address urgent and important unmet needs in the fetal alcohol spectrum disorders (FASD) field through an integrated and multidisciplinary research approach. These unmet needs include identifying FASD cases early and accurately, improving interventions to mitigate FASD outcomes; expanding basic and mechanistic understanding of alcohol teratogenesis aimed at accelerated translation, and reducing prenatal alcohol exposure and the incidence of FASD.

Cooperative Agreement (U01) applications in response to this FOA should propose individual clinical or basic research projects.


Prenatal alcohol exposure is a major public health concern as it causes a spectrum of lifelong, debilitating consequences for the affected individual, including birth defects, mild to severe cognitive impairment, and emotional and behavioral issues. Collectively these deficits known as fetal alcohol spectrum disorders (FASD) affect an estimated 1-5% of all school-aged children in the US. The most serious of these is fetal alcohol syndrome (FAS), a developmental disorder characterized by craniofacial abnormalities, growth retardation, and nervous system dysfunction that may include mental retardation. In addition to FAS, other FASD diagnostic categories include: partial FAS, which includes the facial and neurodevelopmental deficits of FAS but not the growth deficits; alcohol-related neurodevelopmental disorder (ARND), in which neurobehavioral deficits are present but the facial and physical features of FAS are absent; and alcohol-related birth defects (ARBD), where physical attributes of FAS are seen in the absence of the full syndrome. Children with FASD may exhibit multiple cognitive, behavioral, and emotional deficits that impair daily functioning in many domains. Recently, a new diagnostic schema, Neurobehavioral Disorder Associated with Prenatal Alcohol Exposure (ND-PAE), was developed with an emphasis on the mental health symptoms associated with PAE.

Over the last two decades, the FASD research field has seen significant advances in many areas. Our understanding of prenatal alcohol exposure (PAE)-induced brain pathology and associated facial features, especially among diverse populations and across the lifespan, has been expanded significantly by new imaging and analytical approaches. The range of defects associated with FASD has been better defined at the level of timing, frequency, and amount of PAE; as well as the contribution of genetic and environmental risk factors. Towards interventions, select behavioral-based approaches, as well as medication and nutrition-based therapies, have shown promise of beneficial effects.

Despite this progress, challenges remain. There is an urgent need for more reliable and accurate diagnostic schemes and rapid screening tools for diverse populations and across the lifespan. Development of new therapies and interventions that are efficacious in mitigating multiple domains of dysfunction is critical for improving the lives of individuals with FASD. Moreover, given the high prevalence of FASD, there continues to be a need for new and effective FASD prevention strategies.

In 2003, NIAAA established the Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD), a consortium designed to inform and develop effective interventions and treatment approaches for FASD through a highly integrated multidisciplinary research approach involving basic scientists and clinical investigators and projects. The initiative also supports multiple study cohorts to overcome the limitations of smaller individual studies. Past iterations of the consortium have made significant advances in a number of areas, including human interventions with choline and multi-vitamins, 2D/3D imaging of sentinel and non-sentinel facial features and neurobehavioral profiling for improved diagnosis, longitudinal studies of brain development, biomarker discovery to predict FASD outcomes in children, and mHealth and imaging technologies for case identification and intervention. Many of these advances are poised for translation to improve the clinical management of FASD in diverse populations. And importantly, CIFASD has been successful in training of a new generation of FASD researchers for both independent and collaborative research.

Key Dates:

Open Date (Earliest Submission Date): July 16, 2021
Letter of Intent Due Date(s): July 16, 2021
Application Due Date: August 16, 2021

URL for more information:

Filed Under: Funding Opportunities