Therapies for Children With Autism Spectrum Disorders

Evidence Table. Therapies for children with ASD
Study
Inclusion/Exclusion Baseline
Description Intervention
Criteria/Population Measures Outcomes
Author:
Intervention:
Inclusion criteria: NR Responders
Stigler et al., 2004 Stimulants
• Outpatients hospital-
(CGI-I rating of 1
Country:
based autism treatment
or 2), %:
US
Recent trials: 2.5 mg center
Patients with
Practice
setting:
orally (morning and noon) • Met DSM-IV criteria for
increased by 2.5 mg/week PDD by one of two
if needed
board-certified child and
history of one
stimulant trial:
24.6
Academic
adult psychiatrist
Patients with
Mean dosage ± SD
(range) in mg/day &
duration ± SD (range) in
days:
Methylphenidate (144
total trials):
Dosage: 12.9 ± 11.4 (2.5-
• Recent or past stimulant
trial
• Evaluated in clinic within
Enrollment Period
Exclusion criteria:
See inclusion criteria
history of two
stimulant trials:
23.2
Patients with
history of three
stimulant trials
responded to first
80)
Duration: 545.1 ± 731.2
(1-3650)
Age, mean/yrs ± SD
(range) :
G1: 7.26 ± 3.45 (2-19)
trial: 11.1
Responders, n/N
(%):
Amphetamine/dextroamp Mental age:
hetamine (68 total trials): NR
Dosage: 10.4 ± 7.1 (2.5- Gender:
45)
G1:
Duration: 237.3 ±324.8 (1- M, n (%): 174 (89)
1095)
F, n (%): 21 (11)
(Did not respond
to 1 st trial)
2 nd trial: 6/43
(14.05)
3 rd trial: 2/14
(14.3)
Intervention
setting:
Clinic
Enrollment
period:
October 1997 to
January 2002
Funding:
National Alliance
for Research in
Schizophrenia and
Depression.
NIH.
Department of
Housing and
Urban
development
Author industry
relationship
disclosures:
NR
Design:
Retrospective
case series
Stigler et al., 2004
(continued)
Dextroamphetamine (39
total trials):
Dosage: 5.8 ± 2.8 (2.5-10)
Duration: 196.5 ± 340.6
(7-1424)
Pemoline (23 total trials) :
Dosage: 33.3 ± 18.2
(18.5-75)
Duration: 557.2 ± 889.1
(14-2492)
Assessments:
CGI-I administered pre-
and post-trial (clinician
and parent report) to
determine improvement
Groups:
G1: Stimulants
Co-interventions held
stable during treatment:
Yes
Frequency of contact
during study:
NR
Concomitant therapies,
n:
Atypical antipsychotics:
Race/ethnicity:
NR
SES:
Maternal education: NR
Household income: NR
Diagnostic approach:
In-study
Diagnostic tool/method:
DSM-IV criteria clinical
Diagnostic category, n
(%):
G1:
Autistic disorder: 104 (53)
Asperger’s disorder: 34
(17)
PDD-NOS: 57 (29)
Other characteristics, n
(%):
Mental retardation: 93 (48)
C-350
Harms:
Adverse Effects, n
(%):
Aggression: 15 (8)
Agitation: 50 (26)
Anxiety: 2 (1)
Dyspepsia: 15 (8)
Dysphoria: 23
(12)
Insomnia: 10 (5)
Irritability: 16 (8)
Sedation: 2 (1)
Tics: 9 (5)
Weight loss: 14
(7)
Total: 154/268
trials (57.5)
Modifiers:
PDD subtype (P <
0.013)
Use of
concomitant
medication (P <
0.007)