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: Overall ratings: Overall ratings:
Chez et al., 2003 Donepezil hydrochloride • Ages 2-10 years CARS score, mean CARS score, 6
Country:
US
Practice
setting:
(DH), 6 weeks, QD, 2.5 • Prior diagnosis of AD,
mgs (dose was decreased PDD-NOS, or Landauto
1.25 mgs if parents Kleffner Syndrome
noted persistent GI Exclusion criteria:
± SD:
G1: 34.7 ± 7.7
G2: 35.1 ± 7.9
G1/G2: P = NS
weeks, mean ±
SD:
G1: 33.3 ± 8.0
G2: 32.9 ± 7.7
Specialty center
Intervention
setting:
Clinic
Enrollment
period:
NR
Funding:
NR
Author industry
relationship
disclosures:
NR
Design:
RCT
distress or changes in • Concomitant
Communication/ G1/BL: P = NS
behavior and discontinued neurological syndrome language: G2/BL: P < 0.05
if GI intolerability or or disease with EOWPVT-R score, G1/G2: P = NS
behavior changes lasted neurological compromise mean ± SD: CARS, 12 weeks,
> 1 day – considered an (e.g., neurofibromatosis) G1: 35.7 ± 27.8 mean ± SD:
adverse event)
Age, years (range): G2: 31.9 ± 31.1 G1: 30.8 ± 7.9
Placebo: first 6 weeks of G1: 6.8 (2.1-9.9)
G1/G2: P = NS G2: 30.9 ± 9.1
placebo then 6 weeks G2: 6.9 (4.1-10.3) ROWPVT 11 score, G1/BL: P < 0.05
open label treatment for Mental age:
mean ± SD: G2/BL: P < 0.05
all subjects
NR
G1: 38.8 ± 23.5 G1/G2: P = NS
Assessments:
Gender, n (%):
G2: 33.5 ± 27.9 Communication/
Each completed at Male:
G1/G2: P = NS language:
baseline and 6 weeks: G1: 19 (83)
EOWPVT-R
ROWPVT 11 (clinician); G2: 16 (80)
score, 6 weeks,
EOWPVT-R (clinician); Female:
mean ± SD:
CARS (clinician and G1: 4 (17)
G1: 43.3 ± 27.2
parent also completed at G2: 4 (20)
G2: 33.8 ± 32.9
12-week appointment) Race/ethnicity:
G1/BL: P < 0.05
Groups:
NR
G2/BL: P = NS
G1: DH capsule SES:
G1/G2: P = NS
G2: placebo/DH capsule Maternal education: NR
EOWPVT-R
Co-interventions held Household income: NR
score, 12 weeks,
stable during treatment: Diagnostic approach:
mean ± SD:
NR
In Study
G1: 42.5 ± 28.5
Frequency of contact Diagnostic tool/method:
G2: 40.9 ± 38.8
during study:
DSM-IV
G1/BL: P < 0.05
Testing administered at Diagnostic category, n:
G2/BL: P < 0.05**
baseline, 6 weeks and 12 Autistic disorder:
G1/G2: P = NS
weeks; weekly phone logs G1: 8
ROWPVT 11
Concomitant therapies, G2: 5
score, 6 weeks,
n (%):
PDD-NOS:
mean ± SD:
Anticonvulsants G1: 14
G1: 50.3 ± 27.0
(divalproex sodium, G2: 13
G2: 39.83 ± 27
valproic acid or
Landau-Kleffner syndrome:
G1/BL: P < 0.05
lamotrigine):
G1: 1
G2/BL: P = NS
G1: 20
G2: 2
G1/G2: P = NS
G2: 12
Other characteristics, n
ROWPVT 11
Corticosteroids (pulse (%):
score, 12 weeks,
dose prednisone or Nocturnal epileptiform EEG
mean ± SD:
prednisolone):
abnormalities: 28 (72)
G1: 49.7 ± 34.2
G1: 4
Normal 24 EEG patterns:
G2: 87.37 ± 14.2
G2: 2
11 (28)
G1/BL: P < 0.05**
G2/BL: P <
0.05***
G1/G2: P = NS
Chez et al., 2003 CNS stimulants
Harms:
(continued) (dextroamphetamine/
First 6 weeks:
amphetimine or
Increased
methylphenidate):
irritability, mood
G1: 5
swings, crying,
G2: 3
lability:
C-355