Medication and parent training in children with pervasive developmental disorders and serious behavior problems: results from a randomized clinical trial

Autor: Roumen Nikolov, Stacie L. Pozdol, Yaser Ramadan, L. Eugene Arnold, Jill A. Hollway, Louise Ritz, Eric Butter, Naomi B. Swiezy, Karen Bearss, Allison Gavaletz, Stacie Trollinger, Kimberly A. Stigler, Kathleen Koenig, Ann Wagner, Lawrence Scahill, Michael G. Aman, Patricia Korzekwa, Sunkyung Yu, Christopher J. McDougle, Arlene E. Kohn, Luc Lecavalier, Denis D. Sukhodolsky, Benjamin L. Handen, Cynthia R. Johnson, Kristy L. Hall, James Dziura, James A. Mulick, Benedetto Vitiello
Rok vydání: 2009
Předmět:
Male
Pediatrics
medicine.medical_specialty
Child Development Disorders
aripiprazole
autistic disorder
parent management training
pervasive developmental disorders
risperidone
Adolescent
Antipsychotic Agents
Behavior Therapy
Child
Child Behavior Disorders
Child Development Disorders
Pervasive

Child
Preschool

Combined Modality Therapy
Dose-Response Relationship
Drug

Double-Blind Method
Female
Humans
Personality Assessment
Psychometrics
Risperidone
Education
Developmental and Educational Psychology
Psychiatry and Mental Health
medicine.drug_class
Atypical antipsychotic
Irritability
Article
law.invention
Dose-Response Relationship
Randomized controlled trial
law
Pervasive developmental disorder
medicine
Psychiatry
Preschool
Pervasive
medicine.disease
Developmental disorder
Parent training
Aripiprazole
medicine.symptom
Drug
Psychology
medicine.drug
Zdroj: Journal of the American Academy of Child and Adolescent Psychiatry. 48(12)
ISSN: 1527-5418
Popis: Objective Many children with pervasive developmental disorders (PDDs) have serious, functionally impairing behavioral problems. We tested whether combined treatment (COMB) with risperidone and parent training (PT) in behavior management is superior to medication alone (MED) in improving severe behavioral problems in children with PDDs. Method This 24-week, three-site, randomized, parallel-groups clinical trial enrolled 124 children, aged 4 through 13 years, with PDDs, accompanied by frequent tantrums, self-injury, and aggression. The children were randomized 3:2 to COMB ( n = 75) or MED ( n = 49). The participants received risperidone monotherapy from 0.5 to 3.5 mg/day (with switch to aripiprazole if risperidone was ineffective). Parents in the COMB group ( n = 75; 60.5%) received a mean of 10.9 PT sessions. The primary measure of compliance was the Home Situations Questionnaire (HSQ) score. Results Primary: intent-to-treat random effects regression showed that COMB was superior to MED on HSQ ( p = .006) [effect size at week 24 ( d ) = 0.34]. The HSQ score declined from 4.31 (±1.67) to 1.23 (±1.36) for COMB compared with 4.16 (±1.47) to 1.68 (±1.36) for MED. Secondary: groups did not differ on Clinical Global Impressions–Improvement scores at endpoint; compared with MED, COMB showed significant reductions on Aberrant Behavior Checklist Irritability ( d = 0.48; p = .01), Stereotypic Behavior ( d = 0.23; p = .04), and Hyperactivity/Noncompliance subscales ( d = 0.55; p = .04). Final risperidone mean dose for MED was 2.26 mg/day (0.071 mg/kg), compared with 1.98 mg/day for COMB (0.066 mg/kg) ( p = .04). Conclusions Medication plus PT resulted in greater reduction of serious maladaptive behavior than MED in children with PDDs, with a lower risperidone dose.
Databáze: OpenAIRE