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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.

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Acknowledgment

This study was supported by contracts from the National Institute of Mental Health (N01MH70001 to Dr. McDougle, N01MH70009 to Dr. Scahill, N01MH80011 to Dr. Aman, and N01MH70010 to Dr. McCracken), General Clinical Research Center grants from the National Institutes of Health (M01 RR00750 to Indiana University, M01 RR06022 to Yale University, M01 RR00034 to Ohio State University, and M01 RR00052 to Johns Hopkins University), and Korczak Foundation to Dr. Scahill. This experiment complies with the law of the USA of America, in which it was performed.

The opinions and assertions contained in this report are the private views of the authors and are not to be construed as official or as reflecting the views of the National Institute of Mental Health, the National Institutes of Health, or the Department of Health and Human Services.

Author information

Authors and Affiliations

  1. Department of Psychiatry, Kennedy Krieger Institute, Baltimore, MD, USA

    Elaine Tierney, David Stout & Courtney Wheeler

  2. Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA

    Elaine Tierney

  3. Nisonger Center, Ohio State University, Columbus, OH, USA

    Michael Aman, Krista Pappas & L. Eugene Arnold

  4. National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA

    Benedetto Vitiello

  5. Child Study Center, Yale University, New Haven, CT, USA

    Lawrence Scahill & Andres Martin

  6. Riley Hospital for Children, Indiana University, Indianapolis, IN, USA

    Christopher McDougle & David Posey

  7. Neuropsychiatric Institute, University of California, Los Angeles, Los Angeles, CA, USA

    James McCracken & Bhavik Shah

Authors
  1. Elaine Tierney
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  2. Michael Aman
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  3. David Stout
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  4. Krista Pappas
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  5. L. Eugene Arnold
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  6. Benedetto Vitiello
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  7. Lawrence Scahill
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  8. Christopher McDougle
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  9. James McCracken
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  10. Courtney Wheeler
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  11. Andres Martin
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  12. David Posey
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  13. Bhavik Shah
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Corresponding author

Correspondence to Elaine Tierney.

Additional information

From the Research Units on Pediatric Psychopharmacology Autism Network.

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Tierney, E., Aman, M., Stout, D. et al. Parent satisfaction in a multi-site acute trial of risperidone in children with autism: a social validity study. Psychopharmacology 191, 149–157 (2007). https://doi.org/10.1007/s00213-006-0604-z

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  • DOI: https://doi.org/10.1007/s00213-006-0604-z

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