Medication and parent training in children with pervasive developmental disorders and serious behavior problems: results from a randomized clinical trial.
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.


METHODS
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.
The Nisonger Center UCEDD, Ohio State University, Columbus, OH 43210-1257, USA. aman.1@osu.edu
Michael G
MG
Aman
Christopher J
CJ
McDougle
Lawrence
L
Scahill
Benjamin
B
Handen
L Eugene
LE
Arnold
Cynthia
C
Johnson
Kimberly A
KA
Stigler
Karen
K
Bearss
Eric
E
Butter
Naomi B
NB
Swiezy
Denis D
DD
Sukhodolsky
Yaser
Y
Ramadan
Stacie L
SL
Pozdol
Roumen
R
Nikolov
Luc
L
Lecavalier
Arlene E
AE
Kohn
Kathleen
K
Koenig
Jill A
JA
Hollway
Patricia
P
Korzekwa
Allison
A
Gavaletz
James A
JA
Mulick
Kristy L
KL
Hall
James
J
Dziura
Louise
L
Ritz
Stacie
S
Trollinger
Sunkyung
S
Yu
Benedetto
B
Vitiello
Ann
A
Wagner
D000293:Adolescent; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001521:Behavior Therapy; D002648:Child; D002653:Child Behavior Disorders / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D002659:Child Development Disorders, Pervasive / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D002675:Child, Preschool; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004493:Education; D005260:Female; D006801:Humans; D008297:Male; D010552:Personality Assessment / Q000706:statistics & numerical data; D011594:Psychometrics; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*
D014150:Antipsychotic Agents; D018967:Risperidone