Medication and Parent Training in Children With Pervasive Developmental Disorders and Serious Behavior Problems: Results From a Randomized Clinical Trial

The Nisonger Center UCEDD, Ohio State University, Columbus, OH 43210-1257, USA.
Journal of the American Academy of Child and Adolescent Psychiatry (Impact Factor: 7.26). 10/2009; 48(12):1143-54. DOI: 10.1097/CHI.0b013e3181bfd669
Source: PubMed


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.
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.
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).
Medication 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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    • "While many studies have shown the importance of combining medication and psychosocial interventions (mostly parental education) for children with ADHD, there are only a few studies on the combined medication and behavioral approach in ASD children. Aman et al. (2009) primarily targeted frequent tantrums, self-injury, and aggression in a trial of risperidone treatment and parent training, but the combined effects on hyperactivity were also examined. Results indicated that children who received the combined treatments had lower rates of aggression and greater reduction in hyperactivity (requiring lower risperidone dose), as compared with children who received medication only. "
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