NIH Autism Center of Excellence Network Announces Launch of Most Comprehensive Study of Earliest Possible Causes of Autism

Baltimore/Washington Area One of Three Regions Nationwide Where Research Will Be Conducted

The Johns Hopkins Bloomberg School of Public Health and the Kennedy Krieger Institute, along with other leading autism research centers, are partnering to participate in one of the largest research studies of its kind to investigate early risk factors for Autism Spectrum Disorders (ASD). The network, called the Early Autism Risk Longitudinal Investigation (EARLI), will follow a cohort of up to 1,200 pregnant women who already have a child with autism. The study is considered one of the best-equipped to discover biological markers and environmental risk factors for autism due to its elevated autism risk pregnancy cohort, wide ranging data collection with extensive bio-sampling, length of time it follows pregnant women and their babies, and multi-disciplinary team of expert investigators.

Under the study, researchers at four network field sites in three regions across the nation will study possible environmental risk factors and their interplay with genetic susceptibility during the prenatal, neonatal and early postnatal periods. The project will also investigate early biological indicators of autism. The EARLI Study is one of eleven National Institutes of Health Autism Centers of Excellence projects nationwide.

The Drexel University School of Public Health in Philadelphia is the national coordinator of the EARLI Study network under the direction of principal investigator, Craig Newschaffer, PhD. The local research sites for the study include: Drexel University School of Public Health/Children’s Hospital of Philadelphia (CHOP); University of California at Davis/MIND Institute; Johns Hopkins Bloomberg School of Public Health and Kennedy Krieger Institute; and the Kaiser Permanente Division of Research in Oakland, Calif.

The principal investigators for the Baltimore region are M. Daniele Fallin, PhD, associate professor of epidemiology at the Bloomberg School of Public Health, and Rebecca Landa, PhD, director of the Center for Autism and Related Disorders at the Kennedy Krieger Institute.

According to EARLI researchers in the study, the study’s cohort of elevated autism risk pregnancies will help to greatly advance the understanding of possible autism environmental risk factors and biomarkers during different developmental windows, as well as the interplay of genetic susceptibility and environmental exposure.

The network also includes a data coordinating center at the University of California at Davis and a central lab and secure bio-sample repository at the Bloomberg School of Public Health.

Participants in the study will be followed for a period of up to four years, including the time during pregnancy and up until the newborn baby is three years old. The baby born during the study period will have a number of developmental assessments beginning at six months until three years of age. The older sibling with autism may also have additional assessments to confirm their diagnosis.

Mothers in the EARLI Study will be asked to fill out questionnaires, participate in phone interviews and provide biological samples. Researchers will also collect bio-samples of the newborn from birth through two years of age. The study participants will be compensated for their time as well as reimbursed for travel related expenses for visits to the clinic and will receive reports on the developmental assessments completed on their new babies.

Preliminary analyses are slated to begin as soon as the third year of enrollment. Analyses of the influence of genetic factors on developmental trajectory in high risk siblings are anticipated to begin after four years of EARLI Study enrollment. Other major analyses, including those involving interaction of genes and environment, will follow as more families complete the study protocol.

The EARLI Study was established with a $14 million Autism Centers of Excellence grant awarded by the National Institute of Environmental Health Sciences, National Institute of Mental Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development and National Institute of Neurological Disorders and Stroke, all components of the National Institutes of Health, to the Drexel University School of Public Health.

The EARLI Study is also supported by a $2.5 million grant from Autism Speaks. The funding, made possible by an anonymous donation to Autism Speaks, expanded and linked two complementary multi-site, network studies that are both NIH Autism Centers of Excellence. The funding represented one of the largest public-private partnerships focused on understanding the causes of autism.

ASDs refer to a group of complex neurobiological disorders that today are diagnosed in 1:150 U.S. children. Boys are four times more likely to have an ASD than girls. ASDs are characterized by an impaired ability to relate to others and difficulties with verbal and nonverbal communication. Persons with ASDs also typically have repetitive behaviors, restricted interests, and/or tend to follow rigid routines. Although the degree of impairment across individuals with ASDs can vary, ASD is considered a serious developmental disability.

The causes of autism are unknown and there is currently no cure. The prevalence of autism has increased tenfold in the last decade. The Centers for Disease Control and Prevention consider autism to be a national public health crisis.

For more information about the EARLI Study, please visit http://earlistudy.org or the Bloomberg School's Center for Autism & Developmental Disabilities Epidemiology (CADDE).