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Researchers in the Department of Psychiatry and Behavioral Sciences at Stony Brook University Medical Center are conducting a study of children with attention deficit hyperactivity disorder (ADHD) and severe problems with aggressive behavior. The purpose of the study is to evaluate the safety and effectiveness of stimulant medication alone and in combination with risperidone, an antipsychotic drug, to treat aggression in ADHD-diagnosed children.

"Disruptive behavior disorders with severe aggression constitute a public health problem for which evidence-based treatment options are limited," says Kenneth Gadow, Ph.D., Professor of Psychiatry at SBUMC, and Principal Investigator of the Treatment of Severe Childhood Aggression (TOSCA) study. "The impetus of TOSCA is that increasing numbers of youth with aggression are being treated with atypical antipsychotics without good evidence of safety and incremental advantage over safer stimulants and behavioral treatment."

TOSCA includes evaluating a stimulant medication plus either risperidone or a placebo (inactive substance) throughout the course of one year in children diagnosed with ADHD. Another element of the study involves parents of the children attending weekly training sessions addressing the challenges of parenting a child with aggressive behavior.

TOSCA is also a multi-institutional national clinical trial that will enroll a total of 160 children over the course of four years. Participants will be recruited at four sites: SBUMC, Case Western Reserve University, Ohio State University, and the University of Pittsburgh. Researchers at SBUMC are currently looking to include children with ADHD and aggression for the trial.

To be eligible to participate, children must be between 6 and 12 years of age. Both the child and a parent must be willing to participate in the study. All children will receive a thorough diagnostic evaluation to confirm the diagnosis of ADHD and be screened for symptoms of aggression by a psychiatrist in the Department of Child Psychiatry. All participants receive the stimulant treatment and risperidone or placebo for nine weeks, with a possibility of a three month extension, and follow-up after one year.

Patient visits to the study offices will be weekly for the first three months, followed by three monthly visits and a final visit at the close of one year. Parents will receive nine weeks of parent training during the study period. There is no charge to families for any services.

For more information about TOSCA or to inquire about patient enrollment, please call the Study Director, Dr. Jayne Schneider, at 631-632-3091.
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