title: Effects of risperidone and parent training on adaptive functioning in children with pervasive developmental disorders and serious behavioral problems.
abstract: OBJECTIVE
  Children with Pervasive Developmental Disorders (PDDs) have social interaction deficits, delayed communication, and repetitive behaviors as well as impairments in adaptive functioning. Many children actually show a decline in adaptive skills compared with age mates over time.
  
  
  METHODS
  This 24-week, three-site, controlled clinical trial randomized 124 children (4 through 13 years of age) with PDDs and serious behavioral problems to medication alone (MED; n = 49; risperidone 0.5 to 3.5 mg/day; if ineffective, switch to aripiprazole was permitted) or a combination of medication plus parent training (PT) (COMB; n = 75). Parents of children in COMB received an average of 11.4 PT sessions. Standard scores and Age-Equivalent scores on Vineland Adaptive Behavior Scales were the outcome measures of primary interest.
  
  
  RESULTS
  Seventeen subjects did not have a post-randomization Vineland assessment. Thus, we used a mixed model with outcome conditioned on the baseline Vineland scores. Both groups showed improvement over the 24-week trial on all Vineland domains. Compared with MED, Vineland Socialization and Adaptive Composite Standard scores showed greater improvement in the COMB group (p = .01 and .05, and effect sizes = 0.35 and 0.22, respectively). On Age Equivalent scores, Socialization and Communication domains showed greater improvement in COMB versus MED (p = .03 and 0.05, and effect sizes = 0.33 and 0.14, respectively). Using logistic regression, children in the COMB group were twice as likely to make at least 6 months' gain (equal to the passage of time) in the Vineland Communication Age Equivalent score compared with MED (p = .02). After controlling for IQ, this difference was no longer significant.
  
  
  CONCLUSIONS
  Reduction of serious maladaptive behavior promotes improvement in adaptive behavior. Medication plus PT shows modest additional benefit over medication alone. Clinical trial registration information-RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders; http://www.clinicaltrials.gov; NCT00080145.
authors.affiliation: Child Study Center, New Haven, CT 06520, USA. Lawrence.scahill@yale.edu
authors.forename: Lawrence
authors.initials: L
authors.lastname: Scahill
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: McDougle
authors.forename: Michael G
authors.initials: MG
authors.lastname: Aman
authors.forename: Cynthia
authors.initials: C
authors.lastname: Johnson
authors.forename: Benjamin
authors.initials: B
authors.lastname: Handen
authors.forename: Karen
authors.initials: K
authors.lastname: Bearss
authors.forename: James
authors.initials: J
authors.lastname: Dziura
authors.forename: Eric
authors.initials: E
authors.lastname: Butter
authors.forename: Naomi G
authors.initials: NG
authors.lastname: Swiezy
authors.forename: L Eugene
authors.initials: LE
authors.lastname: Arnold
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Stigler
authors.forename: Denis D
authors.initials: DD
authors.lastname: Sukhodolsky
authors.forename: Luc
authors.initials: L
authors.lastname: Lecavalier
authors.forename: Stacie L
authors.initials: SL
authors.lastname: Pozdol
authors.forename: Roumen
authors.initials: R
authors.lastname: Nikolov
authors.forename: Jill A
authors.initials: JA
authors.lastname: Hollway
authors.forename: Patricia
authors.initials: P
authors.lastname: Korzekwa
authors.forename: Allison
authors.initials: A
authors.lastname: Gavaletz
authors.forename: Arlene E
authors.initials: AE
authors.lastname: Kohn
authors.forename: Kathleen
authors.initials: K
authors.lastname: Koenig
authors.forename: Stacie
authors.initials: S
authors.lastname: Grinnon
authors.forename: James A
authors.initials: JA
authors.lastname: Mulick
authors.forename: Sunkyung
authors.initials: S
authors.lastname: Yu
authors.forename: Benedetto
authors.initials: B
authors.lastname: Vitiello
mesh_terms: D000223:Adaptation, Psychological / Q000187:drug effects*; D000293:Adolescent; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D020817:Asperger Syndrome / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D001321:Autistic Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D057189:Checklist; D002648:Child; D002653:Child Behavior Disorders / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D002659:Child Development Disorders, Pervasive / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D002675:Child, Preschool; D003131:Combined Modality Therapy; D003142:Communication; D003299:Cooperative Behavior; D004305:Dose-Response Relationship, Drug; D004493:Education; D005260:Female; D006801:Humans; D008297:Male; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*; D012951:Socialization
chemical_list: D014150:Antipsychotic Agents; D018967:Risperidone