COLUMBUS, Ohio - Previous research published by researchers at The Ohio State University Wexner Medical Center and three other institutions showed that when children with attention-deficit/hyperactivity disorder (ADHD) and serious physical aggression were prescribed both a stimulant and an antipsychotic drug, along with teaching parents behavior management techniques, they had a reduction of aggressive and serious disruptive behavior.
Now, L. Eugene Arnold and Michael Aman, professors emeritus at the Nisonger Center at Ohio State's Wexner Medical Center, and their colleagues have published a study, available online today in the Journal of Child and Adolescent Psychopharmacology (JCAP), showing the addition of risperidone to parent training and a stimulant also improves teachers' assessments of anxiety and social avoidance. Improvement in teacher-rated anxiety and social withdrawal also contributed to improvements in parent-rated disruptive behavior. Children who showed reduced anxiety also showed less disruptive behavior.
For the "Treatment of Severe Childhood Aggression (TOSCA) Study," 168 children (ages 6-12) who had been diagnosed with ADHD and disruptive behavior disorder (DBD) and displayed severe physical aggression were randomly assigned to two groups: parent training plus stimulant plus placebo (Basic treatment) or parent training plus stimulant plus the antipsychotic drug risperidone (Augmented treatment). All participants received only parent training plus stimulant for the first three weeks of the nine-week study.
"We wanted to see if we could expand or augment treatment by adding a second medication. So, we added a placebo for the 'Basic group' and added risperidone for the 'Augmented group,' if there was room for improvement at the end of the third week," said Aman, also coordinating principal investigator of the multi-site study.
Teacher ratings showed a significant advantage for the "Augmented group" receiving the stimulant drug plus risperidone and parent training, compared to the "Basic group," for symptoms of anxiety.
"Clinicians need to attend to both internal emotional and external behavioral symptoms in children presenting with aggressive symptoms. Aggression accompanied by anxiety and social avoidance may partially reflect an anxiety-driven fight-or-flight reaction, which we speculate may respond to specific anxiety treatment," Arnold said. "This possibility deserves further exploration."
Other researchers involved in the study from Johns Hopkins University, Stony Brook University and the University of Pittsburg include Drs. Kenneth D. Gadow, Cristan A. Farmer, Robert L. Findling, Oscar Bukstein, Brooke B.S.G. Molina, Nicole V. Brown, Xiaobai Li, E. Victoria Rundberg-Rivera, Srihari Bangalore, Kristin Page, Elizabeth A. Hurt, Robert Rice and Nora K. McNamara.
This research was funded by the National Institute of Mental Health and was conducted by the Ohio State Nisonger Center's Clinical Trials Program, which specializes in studies of new treatments for ADHD and autism.
In addition, two other TOSCA studies appear online today in JCAP:
- Aman and collaborators looked for predictors and moderators of treatment outcomes in children with severe aggression, DBD and ADHD. They found that "callous and unemotional" traits and ADHD symptom severity were predictors of outcome, whereas anger and irritability symptoms, manic scores and maternal education variously influenced changes in disruptive or prosocial behavior.
- The multi-site team surveyed 150 of the participating families and reported remarkably high levels of satisfaction with the research experience (e.g., 98 percent said they would recommend the study to other parents of children having similar difficulties). Parents enthusiastically endorsed the parent training provided.
"We strongly recommend parent training or similar psychosocial support in future trials," Aman said.