ABSTRACT
OBJECTIVE: The purpose of this study was to examine the satisfaction of families who participated in the Treatment of Severe Childhood Aggression (TOSCA) study. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRY: Treatment of Severe Childhood Aggression (The TOSCA Study), NCT00796302, clinicaltrials.gov .
Subject(s)
Aggression/drug effects , Attention Deficit Disorder with Hyperactivity/drug therapy , Attention Deficit and Disruptive Behavior Disorders/drug therapy , Central Nervous System Stimulants/therapeutic use , Risperidone/therapeutic use , Antipsychotic Agents/administration & dosage , Antipsychotic Agents/therapeutic use , Attention Deficit Disorder with Hyperactivity/complications , Attention Deficit and Disruptive Behavior Disorders/complications , Central Nervous System Stimulants/administration & dosage , Child , Double-Blind Method , Drug Therapy, Combination , Female , Humans , Male , Parents/education , Parents/psychology , Patient Satisfaction , Risperidone/administration & dosage , Severity of Illness Index , Surveys and Questionnaires , Treatment OutcomeABSTRACT
OBJECTIVE: Characteristics of psychotropic medication use have rarely been investigated for special education students with emotional and/or behavioral disorders. METHODS: The prevalence of psychotropic medication use was obtained at the beginning of a school year for a cohort of 77 students attending a self-contained middle school for special education students with emotional and/or behavioral problems, in the suburban New York City area. Demographics, intelligence quotient (IQ) and achievement testing, and objective measures of both psychopathology and school functioning were gathered. RESULTS: Overall, psychotropic medication was used in 77.9% of the participants; 52.0% received more than one medication. The most commonly prescribed medicines were atypical antipsychotics (49.4%) followed by attention-deficit/hyperactivity disorder (ADHD) medications (48.0%). Usage patterns for specific diagnostic presentations were examined, and appeared consistent with current clinical practice. Persistent elevated psychopathology appeared frequently in students on medication. CONCLUSIONS: Psychotropic medication use in this unique but important sample of special education students appeared generally consistent with recent psychotropic prevalence research. The need for collaboration between special education teachers and prescribing physicians, in order to achieve optimal medication adjustment for these students, was highlighted.
