Abstract | OBJECTIVE: METHODS: A total of 168 children ages 6-12 with severe aggression (physical harm), DBD, and ADHD were randomized to parent training plus stimulant plus placebo (basic treatment) or parent training plus stimulant plus risperidone (augmented treatment) for 9 weeks. All received only parent training plus stimulant for the first 3 weeks, then those with room for improvement received a second drug (placebo or risperidone) for 6 weeks. CASI-4R category item means at baseline and week 9 were entered into linear mixed-effects models for repeated measures to evaluate group differences in changes. Mediation of the primary DBD outcome was explored. RESULTS: Parent ratings were nonsignificant with small/negligible effects, but teacher ratings (n=46 with complete data) showed significant augmented treatment advantage for symptoms of anxiety (p=0.013, d=0.71), schizophrenia spectrum (p=0.017, d=0.45), and impairment in these domains (p=0.02, d=0.26), all remaining significant after false discovery rate correction for multiple tests. Improvement in teacher-rated anxiety significantly (p=0.001) mediated the effect of risperidone augmentation on the primary outcome, the Disruptive-total of the parent-rated Nisonger Child Behavior Rating Form. CONCLUSIONS: Addition of risperidone to parent training plus stimulant improves not only parent-rated DBD as previously reported, but also teacher-rated anxiety-social avoidance. Improvement in anxiety mediates improvement in DBD, suggesting anxiety-driven fight-or-flight disruptive behavior with aggression, with implications for potential treatment strategies. Clinicians should attend to possible anxiety in children presenting with aggression and DBD. CLINICAL TRIAL REGISTRY: Treatment of Severe Childhood Aggression (The TOSCA Study). NCT00796302. clinicaltrials.gov.
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Authors | L Eugene Arnold, Kenneth D Gadow, Cristan A Farmer, Robert L Findling, Oscar Bukstein, Brooke S G Molina, Nicole V Brown, Xiaobai Li, E Victoria Rundberg-Rivera, Srihari Bangalore, Kristin Buchan-Page, Elizabeth A Hurt, Robert Rice, Nora K McNamara, Michael G Aman |
Journal | Journal of child and adolescent psychopharmacology
(J Child Adolesc Psychopharmacol)
Vol. 25
Issue 3
Pg. 203-12
(Apr 2015)
ISSN: 1557-8992 [Electronic] United States |
PMID | 25885010
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antipsychotic Agents
- Central Nervous System Stimulants
- Risperidone
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Topics |
- Aggression
(drug effects)
- Antipsychotic Agents
(administration & dosage, therapeutic use)
- Anxiety Disorders
(complications, drug therapy)
- Attention Deficit Disorder with Hyperactivity
(complications, drug therapy)
- Attention Deficit and Disruptive Behavior Disorders
(complications, drug therapy)
- Central Nervous System Stimulants
(administration & dosage, therapeutic use)
- Child
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Humans
- Male
- Parents
(education)
- Risperidone
(administration & dosage, therapeutic use)
- Social Behavior
- Treatment Outcome
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