TOSCA Study
Treatment of
Severe Childhood Aggression
This study will look at the safety and effectiveness of the use of methylphenidate (Concerta®) alone and in combination with
risperidone to treat aggression in children who have been diagnosed with ADHD. Children between the ages of 6-12 may be eligible to
participate in the study.
Following initial assessments to determine that a child is healthy and appropriate for the study, he or she will begin a 9-week medication
assessment. During the first 3 weeks of this assessment, all children will begin on a low dose of methylphenidate. The dose of
methylphenidate will be adjusted twice per week (as needed) until the best dose for each child is achieved. For the next 6 weeks of the
assessment, half of the children will be randomly assigned (like the flip of a coin) to receive risperidone (in addition to the methylphenidate)
and half of the children will receive placebo. As with the methylphenidate, children will begin on a low dose of risperidone or placebo
and have their dose increased twice a week (as needed) until the best dose of risperidone or placebo for that child is achieved.
Simultaneous to the medication assessment, parents will participate in nine weekly parent education sessions to learn strategies to manage
their child’s aggression and ADHD.
At the completion of the 9-week assessment, children will continue on the medications and complete monthly study visits for 3 months.
Parents will be offered two booster parent education sessions during this time. A final visit will then occur one year after the start of the study.
All study visits will be conducted at our offices at 200 Meyran Avenue. Participants will be compensated for their time.
This study, funded by the National Institute of Mental Health, is currently enrolling interested families. For more information on this study,
please do not hesitate to contact Heidi Kipp, M.Ed., L.P.C at 412-246-5661 or
kipphl@upmc.edu or Jennifer Baker at 412-246-5651 or
bakerjl@upmc.edu.
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