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

TitleTrial design challenges when combining medication and parent training in children with pervasive developmental disorders.
Publication TypeJournal Article
Year of Publication2009
AuthorsScahill, L, Aman MG, McDougle CJ, Arnold EL, 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
JournalJournal of autism and developmental disorders
Volume39
Issue5
Pagination720-9
Date Published2009 May
ISSN1573-3432
KeywordsAdolescent, Aggression, Behavior Therapy, Child, Child Development Disorders, Pervasive, Combined Modality Therapy, Dopamine Antagonists, Female, Humans, Male, Outpatients, Parent-Child Relations, Parents, Patient Compliance, Personality Assessment, Psychiatric Status Rating Scales, Risperidone, Self-Injurious Behavior, Treatment Outcome
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 At week 24, the medication was gradually withdrawn to determine whether subjects in the combined treatment group could be managed on a lower dose or off medication without relapse.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.

DOI10.1016/j.brat.2011.06.001
Alternate JournalJ Autism Dev Disord