Psychopharmacology

, Volume 191, Issue 1, pp 149–157 | Cite as

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

  • Elaine Tierney
  • Michael Aman
  • David Stout
  • Krista Pappas
  • L. Eugene Arnold
  • Benedetto Vitiello
  • Lawrence Scahill
  • Christopher McDougle
  • James McCracken
  • Courtney Wheeler
  • Andres Martin
  • David Posey
  • Bhavik Shah
Original Investigation

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.

Keywords

Autism Consumer satisfaction Parent satisfaction Clinical trial Child Risperidone 

Notes

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.

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Copyright information

© Springer-Verlag 2006

Authors and Affiliations

  • Elaine Tierney
    • 1
    • 2
  • Michael Aman
    • 3
  • David Stout
    • 1
  • Krista Pappas
    • 3
  • L. Eugene Arnold
    • 3
  • Benedetto Vitiello
    • 4
  • Lawrence Scahill
    • 5
  • Christopher McDougle
    • 6
  • James McCracken
    • 7
  • Courtney Wheeler
    • 1
  • Andres Martin
    • 5
  • David Posey
    • 6
  • Bhavik Shah
    • 7
  1. 1.Department of PsychiatryKennedy Krieger InstituteBaltimoreUSA
  2. 2.Department of Psychiatry and Behavioral SciencesJohns Hopkins University School of MedicineBaltimoreUSA
  3. 3.Nisonger CenterOhio State UniversityColumbusUSA
  4. 4.National Institute of Mental HealthNational Institutes of HealthBethesdaUSA
  5. 5.Child Study CenterYale UniversityNew HavenUSA
  6. 6.Riley Hospital for ChildrenIndiana UniversityIndianapolisUSA
  7. 7.Neuropsychiatric InstituteUniversity of California, Los AngelesLos AngelesUSA

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