What does risperidone add to parent training and stimulant for severe aggression in child attention-deficit/hyperactivity disorder?
ABSTRACT Although combination pharmacotherapy is common in child and adolescent psychiatry, there has been little research evaluating it. The value of adding risperidone to concurrent psychostimulant and parent training (PT) in behavior management for children with severe aggression was tested.
One hundred sixty-eight children 6 to 12 years old (mean age 8.89 ± 2.01 years) with severe physical aggression were randomized to a 9-week trial of PT, stimulant (STIM), and placebo (Basic treatment; n = 84) or PT, STIM, and risperidone (Augmented treatment; n = 84). All had diagnoses of attention-deficit/hyperactivity disorder and oppositional-defiant disorder (n = 124) or conduct disorder (n = 44). Children received psychostimulant (usually Osmotic Release Oral System methylphenidate) for 3 weeks, titrated for optimal effect, while parents received PT. If there was room for improvement at the end of week 3, placebo or risperidone was added. Assessments included parent ratings on the Nisonger Child Behavior Rating Form (Disruptive-Total subscale was the primary outcome) and Antisocial Behavior Scale; blinded clinicians rated change on the Clinical Global Impressions scale.
Compared with Basic treatment (PT + STIM [44.8 ± 14.6 mg/day] + placebo [1.88 mg/day ± 0.72]), Augmented treatment (PT + STIM [46.1 ± 16.8 mg/day] + risperidone [1.65 mg/day ± 0.75]) showed statistically significant improvement on the Nisonger Child Behavior Rating Form Disruptive-Total subscale (treatment-by-time interaction, p = .0016), the Nisonger Child Behavior Rating Form Social Competence subscale (p = .0049), and Antisocial Behavior Scale Reactive Aggression subscale (p = .01). Clinical Global Impressions scores were substantially improved for the 2 groups but did not discriminate between treatments (Clinical Global Impressions-Improvement score ≤2, 70% for Basic treatment versus 79% for Augmented treatment). Prolactin elevations and gastrointestinal upset occurred more with Augmented treatment; other adverse events differed modestly from Basic treatment; weight gain in the Augmented treatment group was minor.
Risperidone provided moderate but variable improvement in aggressive and other seriously disruptive child behaviors when added to PT and optimized stimulant treatment. Clinical trial registration information-Treatment of Severe Childhood Aggression (The TOSCA Study), URL: http://clinicaltrials.gov, unique identifier: NCT00796302.
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ABSTRACT: The purpose of this study was to examine the satisfaction of families who participated in the Treatment of Severe Childhood Aggression (TOSCA) study. TOSCA was a randomized clinical trial of psychostimulant plus parent training plus placebo (basic treatment) versus psychostimulant plus parent training plus risperidone (augmented treatment) for children with severe physical aggression, disruptive behavior disorder, and attention-deficit/hyperactivity disorder. Parents completed a standardized Parent Satisfaction Questionnaire (PSQ). Of the 168 families randomized, 150 (89.3%) provided consumer satisfaction data. When they were asked if they would join the study again if they had the option to repeat, 136 (91%) said "yes," 11 (7%) said "maybe," and one (<1%) said "no." When asked if they would recommend the study to other parents with children having similar problems, 147 (98%) said "yes" and 3 (2%) said "maybe." Between 71% (rating one aspect of the Parent Training) and 96% (regarding the diagnostic interview) endorsed study procedures using the most positive response option. Asked if there were certain aspects of the study that they especially liked, 64 (43%) spontaneously reported parent training. Treatment assignment (basic vs. augmented) and responder status were not associated with reported satisfaction. However, responder status was strongly associated with parent confidence in managing present (p<0.001) and future (p<0.005) problem behaviors. These findings indicate high levels of satisfaction with TOSCA study involvement and, taken together with previous pediatric psychopharmacology social validity studies, suggest high levels of support for the research experience. These findings may inform research bioethics and may have implications for deliberations of institutional review boards. Treatment of Severe Childhood Aggression (The TOSCA Study), NCT00796302, clinicaltrials.gov .Journal of child and adolescent psychopharmacology 04/2015; 25(3):225-233. DOI:10.1089/cap.2014.0097 · 3.07 Impact Factor
Journal of the American Academy of Child & Adolescent Psychiatry 09/2014; 53(9):942-944. DOI:10.1016/j.jaac.2014.05.018 · 6.35 Impact Factor
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ABSTRACT: Maladaptive aggression in adolescents is an increasing public health concern. Cognitive Behavior Therapy (CBT) is one of the most common and promising treatments of aggression. However, there is a lack of information on predictors of treatment response regarding CBT. Therefore, a meta-analysis was performed examining the role of predictors on treatment response of CBT. Twenty-five studies were evaluated (including 2,302 participants; 1,580 boys and 722 girls), and retrieved through searches on PubMed, PsycINFO and EMBASE. Effect sizes were calculated for studies that met inclusion criteria. Study population differences and specific CBT characteristics were examined for their explanatory power. There was substantial variation across studies in design and outcome variables. The meta-analysis showed a medium treatment effect for CBT to reduce aggression (Cohen'd = 0.50). No predictors of treatment response were found in the meta-analysis. Only two studies did examine whether proactive versus reactive aggression could be a moderator of treatment outcome, and no effect was found of this subtyping of aggression. These study results suggest that CBT is effective in reducing maladaptive aggression. Furthermore, treatment setting and duration did not seem to influence treatment effect, which shows the need for development of more cost-effective and less-invasive interventions. More research is needed on moderators of outcome of CBT, including proactive versus reactive aggression. This requires better standardization of design, predictors, and outcome measures across studies.European Child & Adolescent Psychiatry 08/2014; 24(3). DOI:10.1007/s00787-014-0592-1 · 3.55 Impact Factor