Medication and Parent Training in Children With Pervasive Developmental Disorders and Serious Behavior Problems: Results From a Randomized Clinical Trial |
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| Authors: | Michael G Aman Christopher J Mcdougle Lawrence Scahill Benjamin Handen L Eugene Arnold Cynthia Johnson Kimberly A Stigler Karen Bearss Eric Butter Naomi B Swiezy Denis D Sukhodolsky Yaser Ramadan Stacie L Pozdol Roumen Nikolov Luc Lecavalier Arlene E Kohn Kathleen Koenig Jill A Hollway Patricia Korzekwa Allison Gavaletz Ann Wagner |
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| Institution: | 1. Division of Neurodevelopmental and Behavioral Pediatrics at the University of Rochester, Rochester, NY;2. Nisonger Center UCEDD, The Ohio State University, Columbus;3. University of Pittsburgh School of Medicine;4. Center for Biostatistics, The Ohio State University;1. Emory University;2. Case Western Reserve University;3. Harvard University;4. Ohio State University;5. Vanderbilt University School of Medicine;6. University of California at Los Angeles;7. Johns Hopkins University;8. University of Arizona;9. Virginia Polytechnic University;10. Kings College in London;11. University of Washington;12. National Institute of Mental Health (NIMH);1. The Ohio State University;2. University of Texas–Houston Medical School;3. Stony Brook University;4. University of Pittsburg School of Medicine;5. Case Western Reserve University;6. Stony Brook University Medical Center;7. Nationwide Children''s Hospital of Columbus;8. Children''s Hospital of Pittsburgh of University of Pittsburgh Medical Center;9. Johns Hopkins University;1. Emory University School of Medicine and Marcus Autism Center, Atlanta;2. Yale University School of Nursing, West Haven, CT;3. Harvard Medical School, Massachusetts General Hospital, and Lurie Center for Autism, Boston;4. Nisonger Center, Ohio State University, Columbus;5. Yale School of Medicine, New Haven, CT;6. Division of Child Psychiatry, University of California, Los Angeles;7. Washington University, St. Louis;8. Yale University;9. Emory University School of Medicine;10. National Institute of Mental Health (NIMH), Bethesda, MD;1. Stony Brook University, Stony Brook, NY;2. Center for Biostatistics, Ohio State University, Columbus;3. Nisonger Center, Ohio State University;4. Nisonger Center and is now with Pediatrics and Developmental Neuroscience Branch, National Institute of Mental Health (NIMH), Bethesda, MD;5. University of Pittsburgh;6. University of Pittsburgh and is now with Boston Children''s Hospital and Harvard Medical School;7. Case Western Reserve University, Cleveland, and is now with Johns Hopkins University, Kennedy Krieger Institute, Baltimore;1. ASD Roadmap, 5 Nine Gates Road, Chadds Ford, PA 19317, USA;2. Child Study Center, Yale School of Medicine, 230 South Frontage Road, New Haven, CT 06519, USA;3. Developmental Disorders Unit, Foundations Behavioral Health, 833 East Butler Avenue, Doylestown, PA 18901, USA;4. Neurobehavioral Inpatient Unit, Kennedy Krieger Institute, The Johns Hopkins School of Medicine, 707 North Broadway, Baltimore, MD 21205, USA;5. Neurobehavioral Inpatient Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, The Johns Hopkins School of Medicine, 707 North Broadway, Baltimore, MD 21205, USA |
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| Abstract: | ObjectiveMany 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.MethodThis 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.ResultsPrimary: 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).ConclusionsMedication plus PT resulted in greater reduction of serious maladaptive behavior than MED in children with PDDs, with a lower risperidone dose. |
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