15364
document
Parent-defined target symptoms respond to risperidone in RUPP autism study : customer approach to clinical trials . OBJECTIVE A consumer-oriented efficacy assessment in clinical trials should measure changes in chief complaint and consumer request ( symptoms of most concern to patient/caregiver ) , which may be diluted in change scores of multisymptom scales . METHOD In the Research Units on Pediatric Psychopharmacology ( RUPP ) Autism Network 8-week double-blind trial of risperidone versus placebo , the chief concerns of parents were collected at 0 , 4 , and 8 weeks ( endpoint ) , in addition to standardized primary measures . Blinded clinical judges rated change from baseline to 4 and 8 weeks on a 9-point scale ( 1 = normalized , 5 = unchanged , 9 = disastrous ) ; 94 participants had usable data . RESULTS The most common symptoms identified by parents were tantrums , aggression , and hyperactivity . Interrater reliability was excellent . Mean ratings at endpoint were 2.8 +/- 1.2 on risperidone and 4.5 +/- 1.3 on placebo ( p < .001 ) . Ratings were collinear with Clinical Global Impression-Improvement and Aberrant Behavior Checklist Irritability subscale ( primary dimensional measure ) . Effect size d was 1.4 , compared to 1.2 on the Aberrant Behavior Checklist Irritability subscale . Effect sizes varied twofold by symptom category , largest for self-injury ( 2.11 ) and tantrums ( 1.95 ) . CONCLUSIONS Risperidone was superior to placebo in reducing symptoms of most concern to parents of autistic children with irritable behavior . Rating individualized participant-chosen target symptoms seems a reliable , sensitive , efficient , and consumer-friendly way to assess treatment effect and might have clinical application .
15365
Intervention_Pharmacological
risperidone
15366
Intervention_Pharmacological
risperidone
15367
Intervention_Control
placebo
15368
Intervention_Pharmacological
risperidone
15369
Intervention_Control
placebo
15370
Intervention_Pharmacological
Risperidone
15371
Intervention_Control
placebo
15372
Outcome_Mental
tantrums
15373
Outcome_Mental
aggression
15374
Outcome_Mental
hyperactivity
15375
Outcome_Mental
Interrater reliability
15376
Outcome_Other
Mean ratings at endpoint
15377
Outcome_Other
Clinical Global Impression-Improvement
15378
Outcome_Other
Aberrant Behavior Checklist Irritability
15379
Outcome_Physical
Effect size
15380
Outcome_Other
Aberrant Behavior Checklist
15381
Outcome_Physical
Effect sizes
15382
Outcome_Physical
symptoms
15383
Outcome_Mental
irritable behavior
15384
Participant_Condition
RUPP autism
15385
Participant_Sample-size
94
15386
Participant_Condition
autistic
15387
Participant_Age
children
15388
Participant_Condition
irritable behavior