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Trial Design Challenges When Combining Medication and Parent Training in Children with Pervasive Developmental Disorders

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Abstract

This paper presents the rationale for a 24-week, randomized trial designed to test whether risperidone plus structured parent training would be superior to risperidone only on measures of noncompliance, irritability and adaptive functioning. In this model, medication reduces tantrums, aggression and self-injury; parent training promotes improvement in noncompliance and adaptive functioning. Thus, medication and parent training target related, but separate, outcomes. At week 24, the medication was gradually withdrawn to determine whether subjects in the combined treatment group could be managed on a lower dose or off medication without relapse. Both symptom reduction and functional improvement are important clinical treatment targets. Thus, experimental evidence on the beneficial effects of combining pharmacotherapy and exportable behavioral interventions is needed to guide clinical practice.

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Acknowledgments

This study was supported by the following cooperative agreement grants from the National Institute of Mental Health: U10MH66768 (P.I., M. Aman), U10MH66766 (P.I., C. McDougle), and U10MH66764 (P.I., L. Scahill). The views expressed in this article are those of the authors and do not necessarily reflect the official position of the National Institute of Mental Health, the National Institutes of Health, or any other part of the U.S. Department of Health and Human Services. The authors would like to acknowledge the following people: Stacie Trollinger, Patricia Shugarts, Allison Gavaletz, Kristy Hall, Arlene Kohn, Kathy Koenig, MSN, Maryellen Pachler, MSN, Sue Thompson, MSN, Roumen Niklov, MD, Kristina Siefker, MS, Mariana Zaphiriou, Erin Kustan, Scientific Advisors, Data Safety and Monitoring Board.

Disclosure

Dr. Scahill consults to Janssen Pharmaceutica, Supernus and Bristol-Myers Squibb, Neuropharm, Shire. Dr. Aman consults to Janssen Pharmaceutica, Eli Lilly, Forest Labs and Abbott. Dr. Arnold consults to Eli Lilly, McNeil, Novartis, Noven, Shire, Sigma Tau and Targacept. Dr. McDougle consults to Forest Research Institute, Bristol-Myers Squibb, Eli Lilly, Janssen Pharmaceutica. Dr. McCracken consults to Janssen Pharmaceutica, Eli Lilly, Abbott, Bristol Myers Squibb, Shire, Wyeth, Pfizer, Cephalon, and McNeil. Dr. Handen consults to Bristol Myers Squibb, Forest Labs, Pfizer. The other authors have no financial relationships with for-profit enterprises to disclose.

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Authors and Affiliations

  1. Child Study Center, Yale University, 230 S. Frontage Rd, P.O. Box 207900, New Haven, CT, 06520, USA

    Lawrence Scahill, James Dziura, Denis Sukhodolsky & Karen Bearss

  2. Ohio State University, Columbus, OH, USA

    Michael G. Aman, L. Eugene Arnold, Eric Butter & James Mulick

  3. Indiana University, Indianapolis, IN, USA

    Christopher J. McDougle, Naomi Swiezy & Kimberly Stigler

  4. University of California at Los Angeles, Los Angeles, CA, USA

    James T. McCracken

  5. University of Pittsburgh, Pittsburgh, PA, USA

    Benjamin Handen & Cynthia Johnson

  6. National Institute of Mental Health, Rockville, MD, USA

    Louise Ritz, Ann Wagner & Benedetto Vitiello

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  1. Lawrence Scahill
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  2. Michael G. Aman
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  3. Christopher J. McDougle
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  4. L. Eugene Arnold
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  5. James T. McCracken
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  6. Benjamin Handen
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  7. Cynthia Johnson
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  8. James Dziura
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  9. Eric Butter
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  10. Denis Sukhodolsky
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  11. Naomi Swiezy
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  12. James Mulick
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  13. Kimberly Stigler
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  14. Karen Bearss
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  15. Louise Ritz
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  16. Ann Wagner
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  17. Benedetto Vitiello
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Corresponding author

Correspondence to Lawrence Scahill.

Additional information

From the Research Units on Pediatric Psychopharmacology (RUPP) Autism Network.

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Scahill, L., Aman, M.G., McDougle, C.J. et al. Trial Design Challenges When Combining Medication and Parent Training in Children with Pervasive Developmental Disorders. J Autism Dev Disord 39, 720–729 (2009). https://doi.org/10.1007/s10803-008-0675-2

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  • DOI: https://doi.org/10.1007/s10803-008-0675-2

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