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

Michael G. Aman, Christopher J. Mcdougle, Lawrence Scahill, Benjamin Handen, L. Eugene Arnold, Cynthia Johnson, Kimberly A. Stigler, Karen Bearss, Eric Butter, Naomi Swiezy, Denis D. Sukhodolsky, Yaser Ramadan, Stacie L. Pozdol, Roumen Nikolov, Luc Lecavalier, Arlene E. Kohn, Kathleen Koenig, Jill A. Hollway, Patricia Korzekwa, Allison GavaletzJames A. Mulick, Kristy L. Hall, James Dziura, Louise Ritz, Stacie Trollinger, Sunkyung Yu, Benedetto Vitiello, Ann Wagner

Research output: Contribution to journalArticle

151 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1143-1154
Number of pages12
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume48
Issue number12
DOIs
StatePublished - Dec 2009
Externally publishedYes

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Risperidone
Randomized Controlled Trials
Therapeutics
Problem Behavior
Checklist
Aggression
Compliance
Parents
Clinical Trials
Wounds and Injuries
Surveys and Questionnaires

Keywords

  • aripiprazole
  • autistic disorder
  • parent management training
  • pervasive developmental disorders
  • risperidone

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Developmental and Educational Psychology

Cite this

Medication and Parent Training in Children With Pervasive Developmental Disorders and Serious Behavior Problems : Results From a Randomized Clinical Trial. / Aman, Michael G.; Mcdougle, Christopher J.; Scahill, Lawrence; Handen, Benjamin; Arnold, L. Eugene; Johnson, Cynthia; Stigler, Kimberly A.; Bearss, Karen; Butter, Eric; Swiezy, Naomi; Sukhodolsky, Denis D.; Ramadan, Yaser; Pozdol, Stacie L.; Nikolov, Roumen; Lecavalier, Luc; Kohn, Arlene E.; Koenig, Kathleen; Hollway, Jill A.; Korzekwa, Patricia; Gavaletz, Allison; Mulick, James A.; Hall, Kristy L.; Dziura, James; Ritz, Louise; Trollinger, Stacie; Yu, Sunkyung; Vitiello, Benedetto; Wagner, Ann.

In: Journal of the American Academy of Child and Adolescent Psychiatry, Vol. 48, No. 12, 12.2009, p. 1143-1154.

Research output: Contribution to journalArticle

Aman, MG, Mcdougle, CJ, Scahill, L, Handen, B, Arnold, LE, Johnson, C, Stigler, KA, Bearss, K, Butter, E, Swiezy, N, 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 2009, 'Medication and Parent Training in Children With Pervasive Developmental Disorders and Serious Behavior Problems: Results From a Randomized Clinical Trial', Journal of the American Academy of Child and Adolescent Psychiatry, vol. 48, no. 12, pp. 1143-1154. https://doi.org/10.1097/CHI.0b013e3181bfd669
Aman, Michael G. ; Mcdougle, Christopher J. ; Scahill, Lawrence ; Handen, Benjamin ; Arnold, L. Eugene ; Johnson, Cynthia ; Stigler, Kimberly A. ; Bearss, Karen ; Butter, Eric ; Swiezy, Naomi ; Sukhodolsky, Denis D. ; Ramadan, Yaser ; Pozdol, Stacie L. ; Nikolov, Roumen ; Lecavalier, Luc ; Kohn, Arlene E. ; Koenig, Kathleen ; Hollway, Jill A. ; Korzekwa, Patricia ; Gavaletz, Allison ; Mulick, James A. ; Hall, Kristy L. ; Dziura, James ; Ritz, Louise ; Trollinger, Stacie ; Yu, Sunkyung ; Vitiello, Benedetto ; Wagner, Ann. / Medication and Parent Training in Children With Pervasive Developmental Disorders and Serious Behavior Problems : Results From a Randomized Clinical Trial. In: Journal of the American Academy of Child and Adolescent Psychiatry. 2009 ; Vol. 48, No. 12. pp. 1143-1154.
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T1 - Medication and Parent Training in Children With Pervasive Developmental Disorders and Serious Behavior Problems

T2 - Results From a Randomized Clinical Trial

AU - Aman, Michael G.

AU - Mcdougle, Christopher J.

AU - Scahill, Lawrence

AU - Handen, Benjamin

AU - Arnold, L. Eugene

AU - Johnson, Cynthia

AU - Stigler, Kimberly A.

AU - Bearss, Karen

AU - Butter, Eric

AU - Swiezy, Naomi

AU - Sukhodolsky, Denis D.

AU - Ramadan, Yaser

AU - Pozdol, Stacie L.

AU - Nikolov, Roumen

AU - Lecavalier, Luc

AU - Kohn, Arlene E.

AU - Koenig, Kathleen

AU - Hollway, Jill A.

AU - Korzekwa, Patricia

AU - Gavaletz, Allison

AU - Mulick, James A.

AU - Hall, Kristy L.

AU - Dziura, James

AU - Ritz, Louise

AU - Trollinger, Stacie

AU - Yu, Sunkyung

AU - Vitiello, Benedetto

AU - Wagner, Ann

PY - 2009/12

Y1 - 2009/12

N2 - 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.

AB - 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.

KW - aripiprazole

KW - autistic disorder

KW - parent management training

KW - pervasive developmental disorders

KW - risperidone

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