Principal Investigator: Brooke Molina, PhD
Funding Source: National Institute on Drug Abuse
The TOSCA Study (Treatment of Severe Childhood Aggression) was a multisite randomized clinical trial conducted at the University of Pittsburgh, The Ohio State University, Case Western Reserve University, and the State University of New York, Stony Brook. The purpose of the TOSCA study was to investigate treatments for children aged 6-12 with Attention-Deficit/Hyperactivity Disorder (ADHD) who were also physically aggressive. The study was launched because community providers were using a particular medication for this combination of problems, but a randomized clinical trial had not yet been conducted and was needed to better inform clinical practice. For this study, 168 children and their parent(s)/guardians participated across the four university sites.
In the first phase of TOSCA, an effective dose of long-acting stimulant medication (Concerta® for most of the children) was established for each child while their parent participated in weekly parent training sessions to help them master strategies to manage their child's aggression and ADHD. If the child continued to have impairment despite these two already well-established treatments for ADHD, the child was randomly assigned (like flipping a coin) to either receive risperidone – a medication shown to have positive benefits in reducing aggression - or to receive a placebo (a pill with no active ingredient) in addition to continued stimulant medication and weekly parent education. Everyone completing the assessments in this study - parents, teachers, doctors, etc. - were "blind" to the assignment. This meant that they were not aware of which group the child was assigned to (risperidone or placebo).
Following this first 9-week phase of the study, children who were experiencing positive outcomes - improvement in behavior at home and at school - were invited to participate in a three month follow-up study to determine if improvements in the child's behavior continued over time. Children who had not reached an acceptable level of improvement were referred for further clinical care. All participants were invited back for a final assessment one year after starting the study to again measure long-term outcomes.
The primary results of the study were that risperidone, when added to stimulant medication and parent training, was moderately more effective than placebo in treating the children’s behavior (Aman et al., 2014). One year later, although children were less symptomatic than at study entry, major group differences were not observed and many children continued to experience difficulty (Gadow et al., 2016), suggesting a need for ongoing research into this clinical challenge. We continue to analyze the data and results; you can read about the many findings from the TOSCA on the TOSCA Publications page.