RATIONALE: Subjects who view experimental procedures as worthwhile are more likely to participate in clinical trials and comply with study procedures. Designing studies that consider the consumer's perspective will help to forge a better alliance between participants and researchers. OBJECTIVE: Participant satisfaction is seldom assessed in pharmacological research. In this paper, we report on parent satisfaction in a randomized clinical trial in children with autistic disorder and severely disruptive behavior. METHOD:Parents of 101 children with autism who had participated in a multi-site 8-week double-blind clinical trial ofrisperidone were given a questionnaire at the end to elicit their perceptions of the appropriateness and acceptability of clinical trial procedures. RESULTS: Ninety-six (95.0%) parents returned the questionnaire. Of these, 80.0 to 96.8%, depending on the question, expressed satisfaction with their child's research participation regardless of treatment outcome or assignment to active drug or placebo. In all, 90.5% of parents indicated that they would "definitely" recommend the clinical trial to other families with similar children. A total of 92.7% indicated that they would rejoin the clinical trial if they had to do it all over again. Ethnic minority subjects were more satisfied than white participants with the use of "learning tests". CONCLUSIONS:Parents of children participating in this trial were highly satisfied and supportive of the clinical trial procedures. Random assignment to drug or placebo and the clinical response of their children did not appear to influence their views. Further satisfaction studies of this sort are encouraged.
RCT Entities:
RATIONALE: Subjects who view experimental procedures as worthwhile are more likely to participate in clinical trials and comply with study procedures. Designing studies that consider the consumer's perspective will help to forge a better alliance between participants and researchers. OBJECTIVE:Participant satisfaction is seldom assessed in pharmacological research. In this paper, we report on parent satisfaction in a randomized clinical trial in children with autistic disorder and severely disruptive behavior. METHOD: Parents of 101 children with autism who had participated in a multi-site 8-week double-blind clinical trial of risperidone were given a questionnaire at the end to elicit their perceptions of the appropriateness and acceptability of clinical trial procedures. RESULTS: Ninety-six (95.0%) parents returned the questionnaire. Of these, 80.0 to 96.8%, depending on the question, expressed satisfaction with their child's research participation regardless of treatment outcome or assignment to active drug or placebo. In all, 90.5% of parents indicated that they would "definitely" recommend the clinical trial to other families with similar children. A total of 92.7% indicated that they would rejoin the clinical trial if they had to do it all over again. Ethnic minority subjects were more satisfied than white participants with the use of "learning tests". CONCLUSIONS: Parents of children participating in this trial were highly satisfied and supportive of the clinical trial procedures. Random assignment to drug or placebo and the clinical response of their children did not appear to influence their views. Further satisfaction studies of this sort are encouraged.
Authors: M L Wolraich; L L Greenhill; W Pelham; J Swanson; T Wilens; D Palumbo; M Atkins; K McBurnett; O Bukstein; G August Journal: Pediatrics Date: 2001-10 Impact factor: 7.124
Authors: E Victoria Rundberg-Rivera; Lisa D Townsend; Jayne Schneider; Cristan A Farmer; Brooke B S G Molina; Robert L Findling; Kenneth D Gadow; Oscar G Bukstein; L Eugene Arnold; David J Kolko; Kristin A Buchan-Page; Nora K McNamara; Chenel Michel; Adrienne Austin; Heidi Kipp; Robert R Rice; Michael G Aman Journal: J Child Adolesc Psychopharmacol Date: 2015-04 Impact factor: 2.576
Authors: Jill A Hollway; Michael G Aman; Marissa I Mendoza-Burcham; Laura Silverman; L Eugene Arnold; Rameshwari Tumuluru; Benjamin L Handen; Luc Lecavalier; Kristin Page; Pamela Sayre; Tristram Smith Journal: J Child Adolesc Psychopharmacol Date: 2016-01-21 Impact factor: 2.576