title: Trial design challenges when combining medication and parent training in children with pervasive developmental disorders.
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 At week 24, the medication was gradually withdrawn to determine whether subjects in the combined treatment group could be managed on a lower dose or off medication without relapse.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.
authors.affiliation: Child Study Center, Yale University, New Haven, CT 06520, USA. Lawrence.scahill@yale.edu
authors.forename: Lawrence
authors.initials: L
authors.lastname: Scahill
authors.forename: Michael G
authors.initials: MG
authors.lastname: Aman
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: McDougle
authors.forename: L Eugene
authors.initials: LE
authors.lastname: Arnold
authors.forename: James T
authors.initials: JT
authors.lastname: McCracken
authors.forename: Benjamin
authors.initials: B
authors.lastname: Handen
authors.forename: Cynthia
authors.initials: C
authors.lastname: Johnson
authors.forename: James
authors.initials: J
authors.lastname: Dziura
authors.forename: Eric
authors.initials: E
authors.lastname: Butter
authors.forename: Denis
authors.initials: D
authors.lastname: Sukhodolsky
authors.forename: Naomi
authors.initials: N
authors.lastname: Swiezy
authors.forename: James
authors.initials: J
authors.lastname: Mulick
authors.forename: Kimberly
authors.initials: K
authors.lastname: Stigler
authors.forename: Karen
authors.initials: K
authors.lastname: Bearss
authors.forename: Louise
authors.initials: L
authors.lastname: Ritz
authors.forename: Ann
authors.initials: A
authors.lastname: Wagner
authors.forename: Benedetto
authors.initials: B
authors.lastname: Vitiello
mesh_terms: D000293:Adolescent; D000374:Aggression / Q000187:drug effects / Q000523:psychology*; D001521:Behavior Therapy / Q000379:methods; D002648:Child; D002659:Child Development Disorders, Pervasive / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D003131:Combined Modality Therapy; D018492:Dopamine Antagonists / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D010045:Outpatients; D010287:Parent-Child Relations; D010290:Parents / Q000523:psychology*; D010349:Patient Compliance / Q000523:psychology; D010552:Personality Assessment; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000627:therapeutic use*; D016728:Self-Injurious Behavior / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D018492:Dopamine Antagonists; D018967:Risperidone