Therapies for Children With Autism Spectrum Disorders

Evidence Table. Therapies for children with ASD (continued)
Study
Description Intervention
Inclusion/ Exclusion
Criteria/ Population
C-51
Baseline
Measures Outcomes
G1a: 1 (3.2)
G1b: 0
G1c: 0
G2: 0
Immune system
disorders:**
G1a: 1 (3.2)
G1b: 0
G1c: 0
G2: 0
Vascular
disorders:**
G1a: 0
G1b: 0
G1c: 1 (3.2)
G2: 0
Modifiers:
NR
Comments: *Each subject was considered a responder if he or she was moderately improved or substantially improved on at
least 2 of the last 4 assessments or somewhat improved for all of the last 4 assessments of the MGIS.
**There were no significant differences in adverse events between treatment groups.
Author:
Posey et al.,
2007*
Jahromi et al.,
2009^
RUPP, 2005†
Country:
US
Practice
setting:
Academic
Intervention
setting:
Clinic
Enrollment
period:
November 2001 to
September 2003
Funding:
NIH, Korczak
Foundation
Author industry
relationship
disclosures:
NR†
8 of 18*
Abbott (1)
Amgen (1)
Bard CR (1)
Bristol-Myers
Squibb (4)
Cephalon (1)
Forest (3)
GSK (1)
Jannssen (4)
Intervention, test dose
phase:
Day 1: placebo pill; then 2
days each of 3 different
doses of methylphenidate
(0.125, 0.250, 0.500
mg/kg per dose) 3 times
daily (3 rd dose daily at half
of the earlier doses), in a
stepwise fashion; if
participants had
intolerable side effects to
methylphenidate, they did
not continue to trial phase
Intervention, randomized
crossover phase:
Subjects tolerating
methylphenidate during
the test-dose phase
received a week of
placebo and one week
each of 3 different dose
levels (low, medium, high)
of methylphenidate,
administered by subject
weight. Participants who
could not tolerate the high
dose of methylphenidate
received two weeks of the
medium dose (n=16;
leading to 77 trials of
medium dose in 62
subjects); the high dose
did not follow the placebo
phase to avoid abrupt
Inclusion criteria:
• Children aged 5-14
years with a diagnosis of
autistic disorder,
Asperger disorder, or
PDD-NOS based on
DSM-IV criteria
• Interfering symptoms of
hyperactivity and/or
impulsiveness that were
present for at least 6
months and began prior
to the age of 7 years
• Severity confirmed by
CGI severity subscale
score of ≥ 4 and a total
score ≥ 27 on both
parent- and teacherrated
Swanson, Nolan
and Pelham version IV
ADHD scale, with a
score of at least 10 on
the hyperactivity/
impulsivity subscale;
children also eligible if
hyperactivity/impulsivity
subscale was ≥ 15 even
in the absence of
notable inattentiveness
• No concurrent psychotropic
medications for at
least 1-3 weeks (1 week
for stimulants and
clonidine hydrochloride;
2 weeks for anti-
Overall ratings:
CGI severity subscale
rating, n (%):
Moderately ill: 20
(30.3)
Markedly ill: 35
(52.0)
Severely ill: 11
(16.7)
Educational/cognitive/academic
attainment:
Slosson IQ, mean ±
SD (range):
62.6 ± 32.9 (16-135)
Social skills:
VBS score, mean ±
SD (range):†
Socialization:
61.7 ± 16.7 (20-109)
Communication/
language:
VABS
Communication:
62.8 ± 21.8 (20-126)
Adaptive behavior:
VABS composite:
56.2 ± 21.0 (20-109)
VABS Daily living
skills: 54.4 ± 19.8
(20-110)
Problem behavior:
ABC score, parent-
Overall ratings:
Responded to
treatment, subjects
completing
cross-over phase,
n (%):
Total: 44 (76)
Optimal/best
treatment:†
Placebo: 9 (20)
Low: 11 (25)
Medium: 14 (32)
High: 10 (23)
Response rate, by
dose, n (%):†
G1: 20/61 (33)
G2: 27/77 (35)
G3: 18/47 (38)
G5: 12/61 (20)
G1/G5: P = 0.18
G2/G5: P = 0.05
(including first
medium dose)
G2/G5: P = 0.06
(including first and
second medium
dose when
applicable)
G3/G5: P = 0.07
Social skills:^
Joint attention
(n=33), mean ±
SD
Initiations:
G1: 23.29 ± 16.62