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|Medication and Parent Training in Children With Pervasive Developmental Disorders and Serious Behavior Problems: Results From a Randomized Clinical Trial. |
Aman MG, McDougle CJ, Scahill L, Handen B, Arnold LE, Johnson C, Stigler KA, Bearss K, Butter E, Swiezy NB, Sukhodolsky DD, Ramadan Y, Pozdol SL, Nikolov R, Lecavalier L, Kohn AE, Koenig K, Hollway JA, Korzekwa P, Gavaletz A, Mulick JA, Hall KL, Dziura J, Ritz L, Trollinger S, Yu S, Vitiello B, Wagner A; the Research Units on Pediatric Psychopharmacology Autism Network.
Drs. Aman, Arnold, Butter, Ramadan, Lecavalier, and Mulick and Ms. Hollway and Ms. Hall are with Ohio State University; Drs. McDougle, Stigler, and Swiezy and Ms. Pozdol, Ms. Kohn, and Ms. Korzekwa are with Indiana University; Drs. Scahill, Bearss, Sukhodolsky, Nikolov, and Dziura, and Ms. Koenig, Ms. Gavaletz, and Ms. Yu are with Yale University; Drs. Handen and Johnson are with the University of Pittsburgh; Drs. Vitiello and Wagner and Ms. Ritz are with the National Institute of Mental Health; and Ms. Trollinger is with KAI Research.
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.Clinical trial registration information-RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders.
URL: http://clinicaltrials.gov. Unique identifier: NCT00080145.
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