Therapies for Children With Autism Spectrum Disorders

Evidence Table. Therapies for children with ASD (continued)
Study
Inclusion/ Exclusion Baseline
Description Intervention
Criteria/ Population Measures Outcomes
Novartis (1) lab tests), ADI-R inter- • Lifetime diagnosis of G2: 4.31 ± 1.67 G1/G2: P = 0.006
Noven (1) view, parent ratings on schizophrenia, other ABC irritability ABC irritability
Organon (1) Home Situations
psychotic disorder, or score, mean ± SD: score, week 24,
Shire (2) Questionnaire and ABC, bipolar disorder G1: 29.7 ± 6.10 mean ± SD:
Sigma Tau (1)
Supernus (1)
Targacept (1)
Design:
RCT
and IQ testing; VABS,
CGI-S, CY-BOCS
Assessed at 8 weeks for
response to risperidone
At 16 weeks, a face-toface
“booster” session
and 2 follow-up phone
consultations (conducted
at 2 week intervals) to
maintain treatment gains
Groups:
G1: risperidone
G2: risperidone plus
parent training
• Current diagnosis of
major depression,
obsessive-compulsive
disorder, or substance
abuse
• Significant medical
condition (e.g., heart,
liver, renal, pulmonary
disease), unstable
seizure disorder, or
significant abnormality
on routine laboratory
tests
Age, years ± SD:
G1: 7.5 ± 2.80
G2: 7.38 ± 2.21
G2: 29.3 ± 6.97 G1: 14.53 ± 9.90
ABC hyperactivity/ G2: 10.96 ± 6.64
noncompliance G1/G2: P = 0.01
score, mean ± SD: ABC hyperactivity/
G1: 36.1 ± 6.86 noncompliance
G2: 35.3 ± 9.30 score, week 24,
Adaptive behavior: mean ± SD:
VABS daily living G1: 20.78 ± 12.38
skills score, mean ± G2: 15.38 ± 10.23
SD:
G1/G2: P = 0.04
G1: 41.1 ± 19.8
G2: 50.8 ± 18.5
Aman et al., 2009 Co-interventions held Mental age:
Commonly Commonly
(continued) stable during treatment: NR
occurring occurring
NR
Gender, n (%):
comorbidities: comorbidities:
Treatment fidelity Male: 105 (85)
CYBOCS score, CYBOCS score,
assessed:
Female: 19 (15)
mean ± SD: week 24, mean ±
Yes
Race/ethnicity, n (%): G1: 16.22 ± 2.47 SD:
Frequency of contact White/non-Hispanic: G2: 14.72 ± 2.85 G1: 11.86 ± 4.47
during study:
G1: 34 (69.4)
Home Situations G2: 10.11 ± 3.83
Weekly for first 18 weeks G2: 59 (78.7)
Questionnaire, “yes” G1/G2: P = 0.62
Concomitant therapies, Hispanic:
count, mean ± SD: Harms, n (%):
n (%):
G1: 7 (14.3)
G1: 18.9 ± 3.46 Rhinitis:
Anticonvulsant
G2: 4 (5.3)
G2: 18.6 ± 4.65 G1: 39 (79.6)
medication:
African American: CGI-S score, n (%): G2: 60 (80.0)
G1: 4 (8.2)
G1: 7 (14.3)
Moderate/4: G1/G2: P = 0.96
G2: 0
G2: 9 (12.1)
G1: 14 (28.6) Cough:
N at enrollment: Asian American:
G2: 25 (33.3) G1: 39 (79.6)
G1: 49
G1: 0
Marked/5:
G2: 58 (77.3)
G2: 75
G2: 3 (4.0)
G1: 19 (38.8) G1/G2: P = 0.77
N at 24 week follow-up: Native American
G2: 33 (44.0) Appetite increase:
G1: 40
G2: 55
G1: 1 (2.0)
G2: 0 (0)
Severe/6:
G1: 15 (30.6)
G1: 38 (77.6)
G2: 55 (73.3)
SES:
G2: 17 (22.7) G1/G2: P = 0.6
Maternal education: NR Extreme/7: Fatigue:
Household income: NR G1: 1 (2.0) G1: 33 (67.5)
Diagnostic approach: G2: 0 (0)
G2: 60 (80)
In Study
VABS composite G1/G2: P = 0.11
Diagnostic tool/method: score, mean ± SD: Weight increase:
ADI, DSM-IV
G1: 45.8 ± 15.5 G1: 40 (81.6)
Diagnostic category, n G2: 53.1 ± 15.7 G2: 53 (70.7)
(%):
Educational/ G1/G2: P = 0.17
Autism:
cognitive/ Somnolence:
G1: 32 (65.3)
academic G1: 24 (49.0)
G2: 49 (65.3)
attainment: G2: 32 (42.7)
PDD-NOS:
IQ category, n (%): G1/G2: P = 0.49
G1: 13 (26.5)
Average:
Vomiting:
G2: 22 (29.3)
G1: 11 (22.5) G1: 19 (38.8)
Aspergers:
G2: 28 (38.4) G2: 34 (45.3)
C-34