title: Participant satisfaction in a study of stimulant, parent training, and risperidone in children with severe physical aggression.
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.
  
  
  BACKGROUND
  Treatment of Severe Childhood Aggression (The TOSCA Study), NCT00796302, clinicaltrials.gov .
authors.affiliation: 1 Department of Psychiatry, Stony Brook University School of Medicine , Stony Brook, New York.
authors.forename: E Victoria
authors.initials: EV
authors.lastname: Rundberg-Rivera
authors.forename: Lisa D
authors.initials: LD
authors.lastname: Townsend
authors.forename: Jayne
authors.initials: J
authors.lastname: Schneider
authors.forename: Cristan A
authors.initials: CA
authors.lastname: Farmer
authors.forename: Brooke B S G
authors.initials: BB
authors.lastname: Molina
authors.forename: Robert L
authors.initials: RL
authors.lastname: Findling
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Gadow
authors.forename: Oscar G
authors.initials: OG
authors.lastname: Bukstein
authors.forename: L Eugene
authors.initials: LE
authors.lastname: Arnold
authors.forename: David J
authors.initials: DJ
authors.lastname: Kolko
authors.forename: Kristin A
authors.initials: KA
authors.lastname: Buchan-Page
authors.forename: Nora K
authors.initials: NK
authors.lastname: McNamara
authors.forename: Chenel
authors.initials: C
authors.lastname: Michel
authors.forename: Adrienne
authors.initials: A
authors.lastname: Austin
authors.forename: Heidi
authors.initials: H
authors.lastname: Kipp
authors.forename: Robert R
authors.initials: RR
authors.lastname: Rice
authors.forename: Michael G
authors.initials: MG
authors.lastname: Aman
mesh_terms: D000374:Aggression / Q000187:drug effects*; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001289:Attention Deficit Disorder with Hyperactivity / Q000150:complications / Q000188:drug therapy*; D019958:Attention Deficit and Disruptive Behavior Disorders / Q000150:complications / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D010290:Parents / Q000193:education / Q000523:psychology; D017060:Patient Satisfaction; D018967:Risperidone / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D000697:Central Nervous System Stimulants; D018967:Risperidone