TY - JOUR
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 B.
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
UR - http://www.scopus.com/inward/record.url?scp=71949101279&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=71949101279&partnerID=8YFLogxK
U2 - 10.1097/CHI.0b013e3181bfd669
DO - 10.1097/CHI.0b013e3181bfd669
M3 - Article
C2 - 19858761
AN - SCOPUS:71949101279
SN - 0890-8567
VL - 48
SP - 1143
EP - 1154
JO - Journal of the American Academy of Child and Adolescent Psychiatry
JF - Journal of the American Academy of Child and Adolescent Psychiatry
IS - 12
ER -