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Nicholas Lange, ScD, director of the Neurostatistics Laboratory at McLean Hospital and associate professor of psychiatry at Harvard Medical School, is collaborating with one of the two latest research networks to be been awarded $5.3 million in initial one-year funding from the National Institutes of Health as part of the Autism Centers of Excellence (ACE) Treatment Network program.
Lange is working with the MIND Institute at the University of California, Davis, to conduct multi-site randomized clinical trials to provide information on what effects the style of early intervention for young children with autism, and the intensity of treatment (number of hours per week), have on children’s development. The two styles being compared are naturalistic, play-oriented intervention vs. adult-directed teaching. A second study aims to determine whether toddlers who received early intervention in a previous clinical trial show long-term benefits from the intervention. In an earlier trial, toddlers receiving the intervention showed major improvements in IQ, language, adaptive behavior, and severity of their diagnosis over a two-year study period. The current study will follow participants from toddlerhood up to 6-7 years of age. The questions being addressed in both studies have important implications for health care systems, communities, and families seeking treatment for their children.
Lange will preside over data collected from UC Davis, the University of Washington at Seattle and Vanderbilt University in Nashville, at the independent data coordination and analysis center at McLean, where he will organize the data and conduct analyses at this site to establish continuity of conclusions and neutrality of findings. Lange will be responsible for coordinating the design of a study that involves the enrollment of more than 24 subjects and their families per site, including protocols to randomize the subjects to treatment groups and ensure that data collection is performed with uniformity, and in a way that meets all necessary quotas and unbiased conclusions.
“Having been involved in the early days of the autism research programs sponsored by the NIH, I am particularly proud to be involved in this study,” said Lange. “I have been conducting autism research for over a decade, and as this type of large-scale research grows and gains traction it becomes more and more crucial to coordinate data collection at offsite repositories so that there is a uniform unbiased oversight system in place for collection and reporting data, as well as when performing analysis and drawing conclusions. I am pleased that my lab, and McLean, can be a part of that process.”
With these awards, announced on World Autism Awareness Day, the UC Davis Network and 10 other ACE centers around the country are now being funded for up to five years. The program was created in 2007 to launch an intense and coordinated research effort aimed at identifying the causes of autism spectrum disorders (ASD) and finding new treatments.
ASDs are complex neurodevelopmental disorders that affect how a person behaves, interacts with others, and communicates and learns. The symptoms, skills, and levels of disability present in people diagnosed with an ASD vary widely.
“While progress in research on ASD has been rapid, complex questions remain about the causes of these disorders, how to detect them very early, and how to intervene most effectively,” said National Institute of Mental Health (NIMH) Director Dr. Thomas Insel. “Centers receiving ACE funding have marshaled the interdisciplinary expertise and technical resources needed to move the science forward as quickly as possible.”
The ACE program was established to support collaborative, multidisciplinary science aimed at exploring the causes and identifying the most effective treatments for ASDs. In addition to NIMH, the NIH institutes that support the ACE program are the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Deafness and Other Communication Disorders, the National Institute of Environmental Health Sciences, and the National Institute of Neurological Disorders and Stroke.
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