Parent satisfaction in a multi-site acute trial of risperidone in children with autism: a social validity study.
BACKGROUND
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.


METHODS
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.
Tierney
Elaine
E
Department of Psychiatry, Kennedy Krieger Institute, Baltimore, MD, USA. Tierney@kennedykrieger.org
Aman
Michael
M
Stout
David
D
Pappas
Krista
K
Arnold
L Eugene
LE
Vitiello
Benedetto
B
Scahill
Lawrence
L
McDougle
Christopher
C
McCracken
James
J
Wheeler
Courtney
C
Martin
Andres
A
Posey
David
D
Shah
Bhavik
B
D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001321:Autistic Disorder / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D003258:Consumer Behavior; D004311:Double-Blind Method; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D033282:Parental Consent; D010290:Parents / Q000523:psychology; D012107:Research Design; D018967:Risperidone / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States
D014150:Antipsychotic Agents; D018967:Risperidone