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
Lilly (5)
NR
Education of parent or Daily living: G1: 0.03 ± 0.29
McNeil (2) Frequency of contact primary caregiver, n (%): G1: 40.8 ± 21.0 G2: 0.34 ± 0.41
Novartis (1) during study:
High school or less: G2: 34.0 ± 15.6 G1/G2: P = NS
Noven (1) Weekly during RCT, G1: 9 (18)
Medical:
(ES = 0.81)
Pediamed (1) monthly thereafter G2: 13 (25)
CYBOCS score, Post-extension
Pfizer (4) Concomitant therapies: Trade school or college: mean ± SD:^ phase:
Shire (2)
NR
G1: 33 (67)
G1: 15.51 ± 2.73 G1: 0.10 ± 0.36
Sigma Tau (1) N at RCT enrollment: G2: 31 (60)
G2: 15.18 ± 3.88 VABS communi-
Targacept (1) G1: 49
Advanced degree: BMI, CDC standard cation, standard
Wyeth (1) G2: 52
G1: 7 (14)
score, mean ± SD: score, post-
7 of 17§
N at start of 8 week G2: 8 (15)
G1: 0.4 ± 1.4 extension phase,
Bristol-Myers extension trial:
Annual household income, G2: 0.7 ± 1.3 mean change ±
Squibb (6) G1: 46
n (%):
SARS score, mean ± SD:º
Forest (3)
< $20,000:
SD:
G1: 1.63 ± 8.91
Jannssen (4)
G1: 5/48 (10)
G1: 0.27 ± 0.70 (n=48)
Johnson and
G2: 8/51 (16)
G2: 0.54 ± 1.60 G1/BL: P = NS
Johnson (1)
$20,001-$40,000: AIMS score, mean ± (ES = 0.11)
Lilly (4)
G1: 12/48 (25)
SD:
Repetitive
McNeil (3)
G2: 16/51 (31)
G1: 0.36 ± 0.99 behavior:
Neuropharm (3)
$40,001-$60,000: G2: 0.23 ± 1.02 ABC stereotypy
Novartis (2)
G1: 10/48 (21)
Sleep time, mean score, mean ± SD:
Organon (1)
G2: 7/51 (15)
hours/day:
Post-RCT:‡
Pfizer (1)
> $60,000:
G1: 9.66
G1: 5.8 ± 4.6
Shire (3)
G1: 21/48 (44)
G2: 9.42
G2: 7.3 ± 4.8
Supernus (2)
G2: 20/51 (39)
Serum prolactin, G1/G2: P < 0.001
UCB (1)
Diagnostic approach: mean ng/mL ± SD:ª (ES = 0.8)
Wyeth (1)
In Study
G1: 9.3 ± 7.5 (n=42) (ES = 1.2)
Diagnostic tool/method: G2: 9.3 ± 7.6 (n=36)
Diagnosis corroborated by Motor skills:
ADI-R, administered by a Purdue pegboard,
clinician with special
training and systematic
review to ensure reliability
mean ± SD:§
Aman et al., 2005
Diagnostic category: Dominant hand Problem
McDougle et al.,
See inclusion criteria insert:
behavior:
2005^
CGI-S, RCT population, n G1: 32.76 ± 17.4 ABC irritability
Arnold et al.,
(%)
(n=17)
score, post-RCT,
2003†
Moderate:
G2: 24.08 ± 10.5 mean ± SD:‡
RUPP, 2002‡
G1: 9/49 (18)
(n=13)
G1: 11.3 ± 7.4
Williams et al,
G2: 9/49 (18)
Nondominant hand G2: 21.9 ± 9.5
2006º
Marked:
insert:
G1/G2: P < 0.001
Anderson et al.,
G1: 27/49 (55)
G1: 26.82 ± 18.4 ABC lethargy/
2007ª
G2: 28/49 (57)
(n=17)
social withdrawal
Aman et al., 2008§
Severe:
G2: 22.38 ± 9.9 score, mean ± SD:
Martin et al.,
G1: 12/49 (24)
(n=13)
Post-RCT:‡
2004¥
G2: 12/49 (24)
Dominant hand G1: 8.9 ± 6.4
(continued)
Extreme:
drops:
G2: 12.0 ± 8.3
G1: 1/49 (2)
G1: 2.35 ± 1.9 G1/G2: P = 0.03
Design:
G2: 0
(n=17)
(ES = 0.4)
Randomized trial
Other characteristics, n G2: 2.77 ± 2.4 ABC hyperactivity
with open label
(%):
(n=13)
score, mean ± SD:
continuation phase
Educational placement of Nondominant hand Post-RCT:‡
child, RCT population: drops:
G1: 17.0 ± 9.7
Regular class:
G1: 3.24 ± 3.0 G2: 27.6 ± 10.6
G1: 5/47 (11)
(n=17)
G1/G2: P < 0.001
G2: 3/50 (6)
G2: 2.31 ± 2.4 (ES = 1.0)
Special education program: (n=13)
ABC inappropriate
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