, Volume 191, Issue 1, pp 149-157

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

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Abstract

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.

From the Research Units on Pediatric Psychopharmacology Autism Network.