Severely Aggressive Children Receiving Stimulant Medication Versus Stimulant and Risperidone: 12-Month Follow-Up of the TOSCA Trial

Kenneth D. Gadow, Nicole V. Brown, L. Eugene Arnold, Kristin A. Buchan-Page, Oscar G. Bukstein, Eric Butter, Cristan A. Farmer, Robert L. Findling, David J. Kolko, Brooke S.G. Molina, Robert R. Rice, Jayne Schneider, Michael G. Aman

Research output: Contribution to journalArticlepeer-review


Objective The objective of this study was to evaluate 52-week clinical outcomes of children with co-occurring attention-deficit/hyperactivity disorder (ADHD), disruptive behavior disorder, and serious physical aggression who participated in a prospective, longitudinal study that began with a controlled, 9-week clinical trial comparing the relative efficacy of parent training + stimulant medication + placebo (Basic; n = 84) versus parent training + stimulant + risperidone (Augmented; n = 84). Method Almost two-thirds (n = 108; 64%) of families in the 9-week study participated in week 52 follow-ups (Basic, n = 55; Augmented, n = 53) and were representative of the initial study sample. The assessment battery included caregiver and clinician ratings and laboratory tests. Results Only 43% of participants in the Augmented group and 36% in the Basic group still adhered to their assigned regimen (not significant [NS]); 23% of those in the Augmented group and 11% in the Basic group were taking no medication (NS). Both randomized groups improved baseline to follow-up, but the 3 primary parent-reported behavioral outcomes showed no significant between-group differences. Exploratory analyses indicated that participants in the Augmented group (65%) were more likely (p = .02) to have a Clinical Global Impressions (CGI) severity score of 1 to 3 (i.e., normal to mildly ill) at follow-up than those in the Basic group (42%). Parents rated 45% of children as impaired often or very often from ADHD, noncompliant, or aggressive behavior. The Augmented group had elevated prolactin levels, and the Basic group had decreased weight over time. Findings were generally similar whether groups were defined by randomized assignment or follow-up treatment status. Conclusion Both treatment strategies were associated with clinical improvement at follow-up, and primary behavioral outcomes did not differ significantly. Many children evidenced lingering mental health concerns, suggesting the need for additional research into more effective interventions. Clinical trial registration information—Treatment of Severe Childhood Aggression (the TOSCA Study);; NCT00796302

Original languageEnglish (US)
Pages (from-to)469-478
Number of pages10
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Issue number6
StatePublished - Jun 1 2016


  • ADHD
  • conduct disorder
  • methylphenidate
  • oppositional defiant disorder
  • risperidone

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health


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