TY - JOUR
T1 - Trial design challenges when combining medication and parent training in children with pervasive developmental disorders
AU - Scahill, Lawrence
AU - Aman, Michael G.
AU - McDougle, Christopher J.
AU - Arnold, L. Eugene
AU - McCracken, James T.
AU - Handen, Benjamin
AU - Johnson, Cynthia
AU - Dziura, James
AU - Butter, Eric
AU - Sukhodolsky, Denis
AU - Swiezy, Naomi
AU - Mulick, James
AU - Stigler, Kimberly
AU - Bearss, Karen
AU - Ritz, Louise
AU - Wagner, Ann
AU - Vitiello, Benedetto
N1 - Funding Information:
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.
PY - 2009/5
Y1 - 2009/5
N2 - 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 At week 24, the medication was gradually withdrawn to determine whether subjects in the combined treatment group could be managed on a lower dose or off medication without relapse.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.
AB - 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.
KW - Autism
KW - Behavior therapy
KW - Clinical trial methodology
KW - Risperidone
UR - https://www.scopus.com/pages/publications/67349249372
UR - https://www.scopus.com/pages/publications/67349249372#tab=citedBy
U2 - 10.1007/s10803-008-0675-2
DO - 10.1007/s10803-008-0675-2
M3 - Article
C2 - 19096921
AN - SCOPUS:67349249372
SN - 0162-3257
VL - 39
SP - 720
EP - 729
JO - Journal of Autism and Developmental Disorders
JF - Journal of Autism and Developmental Disorders
IS - 5
ER -