Trial design challenges when combining medication and parent training in children with pervasive developmental disorders

Lawrence Scahill, Michael G. Aman, Christopher J. McDougle, L. Eugene Arnold, James T. McCracken, Benjamin Handen, Cynthia Johnson, James Dziura, Eric Butter, Denis Sukhodolsky, Naomi Swiezy, James Mulick, Kimberly Stigler, Karen Bearss, Louise Ritz, Ann Wagner, Benedetto Vitiello

Research output: Contribution to journalArticle

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 At week 24, the medication was gradually withdrawn to determine whether subjects in the combined treatment group could be managed on a lower dose or off medication without relapse.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.

Original languageEnglish (US)
Pages (from-to)720-729
Number of pages10
JournalJournal of Autism and Developmental Disorders
Volume39
Issue number5
DOIs
StatePublished - May 2009
Externally publishedYes

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Risperidone
Aggression
Recurrence
Drug Therapy
Wounds and Injuries
Therapeutics

Keywords

  • Autism
  • Behavior therapy
  • Clinical trial methodology
  • Risperidone

ASJC Scopus subject areas

  • Developmental and Educational Psychology

Cite this

Trial design challenges when combining medication and parent training in children with pervasive developmental disorders. / Scahill, Lawrence; Aman, Michael G.; McDougle, Christopher J.; Arnold, L. Eugene; McCracken, James T.; Handen, Benjamin; Johnson, Cynthia; Dziura, James; Butter, Eric; Sukhodolsky, Denis; Swiezy, Naomi; Mulick, James; Stigler, Kimberly; Bearss, Karen; Ritz, Louise; Wagner, Ann; Vitiello, Benedetto.

In: Journal of Autism and Developmental Disorders, Vol. 39, No. 5, 05.2009, p. 720-729.

Research output: Contribution to journalArticle

Scahill, L, Aman, MG, McDougle, CJ, Arnold, LE, McCracken, JT, Handen, B, Johnson, C, Dziura, J, Butter, E, Sukhodolsky, D, Swiezy, N, Mulick, J, Stigler, K, Bearss, K, Ritz, L, Wagner, A & Vitiello, B 2009, 'Trial design challenges when combining medication and parent training in children with pervasive developmental disorders', Journal of Autism and Developmental Disorders, vol. 39, no. 5, pp. 720-729. https://doi.org/10.1007/s10803-008-0675-2
Scahill, Lawrence ; Aman, Michael G. ; McDougle, Christopher J. ; Arnold, L. Eugene ; McCracken, James T. ; Handen, Benjamin ; Johnson, Cynthia ; Dziura, James ; Butter, Eric ; Sukhodolsky, Denis ; Swiezy, Naomi ; Mulick, James ; Stigler, Kimberly ; Bearss, Karen ; Ritz, Louise ; Wagner, Ann ; Vitiello, Benedetto. / Trial design challenges when combining medication and parent training in children with pervasive developmental disorders. In: Journal of Autism and Developmental Disorders. 2009 ; Vol. 39, No. 5. pp. 720-729.
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