Therapies for Children With Autism Spectrum Disorders

Evidence Table. Therapies for children with ASD (continued)
Study
Description Intervention
Adams et al.,
2009 (A)
Adams et al.,
2009 (B)†
(continued)
Inclusion/ Exclusion
Criteria/ Population
Comments: * Baseline results reported for participants who completed Phase 2 of study.
** There were no significant differences between G1 (n=24) and G2 (n=12) on the PGI.
Author:
Aman et al., 2009
Country:
US
Practice
setting:
Academic
Intervention
setting:
Clinic and home
Enrollment
period:
NR
Funding:
NIMH; Johnson
and Johnson
provided
risperidone
Author industry
relationship
disclosures:
7 of 28
Abbott (1)
Boehringer-
Ingelheim (1)
Bristol-Myers
Squibb (5)
CureMark (1)
Eli Lilly (1)
Forest (2)
Janssen (2)
Johnson &
Johnson (2)
Neuropharm (3)
Intervention:
Risperidone administered
over first 4 weeks
Dosage by weight:
• 14-20 kg: 0.25 mg/day
with gradual increases
to maximum of 1.75 mg
• 20-45 kg: 0.5 mg/day
with gradual increases
to maximum of 2.5 mg
• > 45 kg: 0.5 mg/day
with gradual increases
to maximum of 3.5 mg
If response to risperidone
was unsatisfactory,
treatment was switched to
aripiprazole, which was
increased as risperidone
was tapered
Parent training: delivered
by one therapist/parent or
couple; 11 core treatment
sessions and 3 optional
treatment sessions/
booster session and two
follow-up phone consults
Assessments:
Stanford Binet IQ, LIPS,
MSEL
Diagnostic assessment,
medical evaluation
(including
electrocardiogram,
medical history, routine
Inclusion criteria:
• Presence of PDD
(autism, PDD-NOS,
Asperger’s) established
by DSM-IV-TR clinical
criteria and corroborated
by ADI-R
• Age 4-13 years
• Score of ≥ 18 on ABC
irritability subscale
• CGI-S score ≥ 4
• Medication free 2 weeks
for most psychotropic
drugs and 4 weeks for
fluoxetine and/or depot
neuroleptics
• IQ ≥ 35 or mental age ≥
18 months as assessed
by Stanford Binet, LIPS,
or Mullen Scales of
Development
• If taking anticonvulsant,
seizure-free ≥ 6 months
and with stable dose for
4 weeks
Exclusion criteria:
• Positive HCG pregnancy
test for females
• Previous adequate trial
of risperidone
• Other PDD (e.g., Rett’s,
childhood disintegrative
disorder)
C-33
Baseline
Measures Outcomes
phase 2 due to
adverse events:
G1: 2
G2: 2
Withdrew from
phase 2 due to
low urinary
excretion of
metals:
G1: 2
G2: 0
Sleep problems,
worsening of
some behavior
and skills, more
self-stimulatory
behavior, and
some regression
Modifiers:
NR
Social skills:
ABC social
withdrawal score,
mean ± SD:
G1: 17.1 ± 8.37
G2: 15.2 ± 9.01
VABS socialization
score, mean ± SD:
G1: 53.5 ± 14.4
G2: 59.5 ± 15.0
Communication/
language:
ABC inappropriate
speech score, mean
± SD:
G1: 6.37 ± 4.03
G2: 5.75 ± 3.43
VABS
communication
score, mean ± SD:
G1: 53.2 ± 19.9
G2: 61.1 ± 20.9
Repetitive
behavior:
ABC stereotypic
behavior score,
mean ± SD:
G1: 10.6 ± 5.46
G2: 7.59 ± 5.2
Problem behavior:
Home Situations
Questionnaire
score, mean ± SD:
G1: 4.16 ± 1.47
Social skills:
ABC social
withdrawal score,
week 24, mean ±
SD
G1: 6.44 ± 7.16
G2: 4.26 ± 5.17
G1/G2: P = 0.78
Communication/
language:
ABC inappropriate
speech score,
week 24, mean ±
SD:
G1: 3.30 ± 3.66
G2: 2.56 ± 2.93
G1/G2: P = 0.20
Repetitive
behavior:
ABC stereotypic
behavior score,
week 24, mean ±
SD:
G1: 6.25 ± 5.68
G2: 3.20 ± 4.09
G1/G2: P = 0.04
Problem
behavior:
Home Situations
Questionnaire
score, week 24,
mean ± SD:
G1: 1.68 ± 1.36
G2: 1.23 ± 1.36