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document
Parent satisfaction in a multi-site acute trial of risperidone in children with autism : a social validity study . 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 .
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Intervention_Pharmacological
risperidone
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Intervention_Pharmacological
risperidone
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Intervention_Control
placebo
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Intervention_Control
placebo
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Outcome_Other
highly satisfied and supportive of the clinical trial procedures
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Participant_Condition
autistic disorder
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Participant_Condition
severely disruptive behavior
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Participant_Sample-size
101
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Participant_Age
children
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Participant_Condition
autism