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

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Abstract

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.

Section snippets

Method

Additional information regarding the background, feasibility, and methods for this study are described in detail elsewhere.12, 18, 34 The institutional review boards of the clinical sites approved this investigation, and the parents or legal guardians of all child participants provided written informed consent.

Subject Characteristics

As shown in Figure 1, 199 potential participants were screened, and 124 (62%) were randomized to this trial. Of the 48 ineligible to participate, 18 (38%) did not have a PDD, 14 (29%) had ABC Irritability scores less than 18 (two children failed both criteria), and five (10%) had other DSM diagnoses that were exclusionary. The remaining screen failures were excluded for a multitude of reasons (across five inclusion/exclusion criteria) or because of a threat to the protocol (e.g., already

Discussion

To our knowledge, this is the first randomized controlled trial to examine the combination of PT and medication in children with PDDs. The primary outcome variable, HSQ score, showed additive benefit (p = .006) with COMB, with a between-groups effect size of 0.34 at week 24. This added effect of PT was detectable over and above the large treatment effect of medication alone. Combined treatment also showed added benefit in reducing the serious behavioral problems that brought the children into

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    This article was reviewed under and accepted by Deputy Editor John T. Walkup, M.D.

    This work was funded by the National Institute of Mental Health by the following RUPP grants: Ohio State University, U10MH66768; Indiana University, U10MH66766; and Yale University, U10MH66764. Johnson & Johnson Pharmaceutical Research & Development provided active risperidone for the study.

    National Institutes of Health participation is reflected above in individual authors' contributions. The views expressed in this article are those of the authors and do not necessarily reflect the official position of the National Institute of Mental Health, the National Institutes of Health, or any other part of the U.S. Department of Health and Human Services.

    The authors acknowledge the contributions of: Ohio State University: Amanda Cook, B.A.; Kristina Humphries, M.S.; Lorelai Ark, M.A.; Susan Thompson, M.S.N., C.P.N.P., Indiana University: Jon T. Diener, B.S.; Kelly A. Ernsperger, L.C.S.W.; Joy M. Fairbanks, M.S.; Jennifer E. Mullett, R.N.; Marianna R. Zaphiriou, B.A. Yale University: Mary Ellen Pachler. National Institute of Mental Health: William R. Harlan, M.D., NIH National Library of Medicine; for support as scientific advisors: Andrew C. Leon, Ph.D., Weill Medical College of Cornell University; Jose Alvir, Dr.P.H., Pfizer, Inc.; C.T. Gordon, M.D., private practice, Rockville, MD; Sandra Harris, Ph.D., Rutgers University, State University of New Jersey; Henrietta Leonard, M.D., Brown University; Susan Swedo, M.D., NIMH Intramural Research Program; Richard Todd, Ph.D., M.D., Washington University School of Medicine.

    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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