Therapies for Children With Autism Spectrum Disorders

Evidence Table. Therapies for children with ASD
Study
Inclusion/Exclusion Baseline
Description Intervention
Criteria/Population Measures Outcomes
**data only illustrated graphically in Figure 2, which appears to erroneously be a reproduction of Figure 1
Evidence Table. Therapies for children with ASD
Study
Inclusion/Exclusion Baseline
Description Intervention
Criteria/Population Measures Outcomes
Author:
Intervention: Risperidone Inclusion criteria: Overall ratings: Overall ratings:
Masi et al., monotherapy. Duration of • Diagnosis of autistic CPRS, mean ± SD: CGAS, mean ± SD:
2003
treatment ranged from 3- disorder or PDD-NOS Total: 51.07 ± 5.2 G1a: 27.1 ± 5.9
Country: 32 months. Started on a according to DSM-IV G1a: 51 ± 5.9 G1b: 33.4 ± 4.7
Italy
dose of 0.25 mg at
criteria and CARS score G1b: 41.8 ± 4.6 P < 0.0001
bedtime. Subsequent above 30
P < 0.0001
Practice
setting:
Third level
titration was by 0.25mg
increments at no more
than weekly intervals
• Absence of comorbid
medical or neurologic
conditions
22 with a CGI-I
score of 1/2
CPRS, mean ± SD:
G1a: 42.5 ± 5.4
G1b: 34.6 ± 3.2
research Hospital
Intervention
setting: Clinic
Enrollment
period: March
depending on clinical • Severe behavioral
response and occurrence symptoms
of side effects. Max daily • Written parental
dose was 1mg.
informed consent to
treatment
Assessments: CPRS,
showed at least a
25% reduction in
CPRS total score
and were
considered
responders
P < 0.0001
Serum Prolactin
level, mean ± SD:
Responders:
24.3 ± 16.3
1999 to April 2002 CGI-I, CGAS, and side Exclusion criteria:
Non-responders:
Funding: effects checklist See inclusion criteria Among responders 27.5 ± 23.2 (P =
NR
administered by Age, mean/yrs ± SD: (n=22):
0.64)
Author industry independent examiners at 4.6 ± 0.7 (3.6-6.6) CARS : 40.1 ± 7
relationship baseline, after 8 wks, and G1a: 4.4 ± 0.6 G1b: 5 ± CPRS: 50.5 ± 6.0 Prolactin level at
disclosures: at irregular intervals 0.8, P = 0.01
last observation:
First author-Eli during follow up (mean Mental age:
Among non- 28.38 ± 22.45 (t = -
Lilly, Pfizer, follow up 7.9±6.8 mos, NR
responders (n=25): 3.8, df = 72, P <
GlaxoSmithKline & range 1-32 mos). CARS, Gender:
CARS: 42.7 ± 5.2 0.0001)
Janssen Griffiths Developmental M, n (%): 45 (84.9) CPRS: 50.7 ± 5.4
Design: Scales, Leiter
F, n (%): 8 (15.1)
G1a: 29 ± 21.3
Prospective case International Performance
Prolactin level, G1b: 26.1 ± 26.0
series
Scale administered at
baseline.
Race/ethnicity:
NR
ng/ml. mean ± SD: P = 0.70
13.3 ± 7.8
Weight in kg, mean
Groups:
G1a: Autistic disorder
G1b: PDD-NOS
SES:
Maternal education: NR
CARS:
G1a: 43.9 ± 5.3
G1b: 35.9 ± 4.0
± SD:
Overall: 23.3 ± 6.3
G1a: 21.5 ± 5.9
Household income: NR P < 0.0001 G1b: 26.1 ± 5.3
P = 0.02
Co-interventions held
stable during treatment:
NR
Frequency of contact
during study:
Behavioral symptoms at
baseline, after 8 weeks
and again at irregular
intervals during follow-up.
Concomitant therapies:
None
N at enrollment: 53
Diagnostic approach:
In Study
Diagnostic tool/method:
Clinical interview, DSM-IV,
CARS score above 30
Diagnostic category, n
(%):
Autism : 37 (69.8)
PDD-NOS : 16 (30.2)
Other characteristics, n
(%):
C-363
CGAS, mean ± SD:
Overall: 20.87± 4.6
G1a: 19.6 ± 4.0
G1b: 23.9 ± 4.6
P = 0.002
Responders/nonresponders:
G1a: 12/21
G1b: 10/4
P = 0.06
Weight in kg, mean
± SD:
Responders / nonresponders:
mean
± SD:
Maximum dosagemg/d:
0.70 ± 0.18 /
0.57 ± 0.16 (P =
0.012)
Optimal dosage,
mg/d:
0.61 ± 0.22 /
0.49 ± 0.16 (P =