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: Communication/ Communication/
Unis et al., Single Infusion of either • Aged 3-12 years language: language:
2002
Country:
extracted porcine secretin • DSM-IV diagnosis of
(2 CU/kg), synthetic autism or PDD-NOS by
ADOS
communication:
ADOS
communication
US
Practice
setting:
porcine secretin (0.4
μg/kg) or an appropriate
volume of placebo over 2
a physician or clinical
psychologist
Exclusion criteria:
score, mean ± SD:
G1: 5.6 ± 1.7
G2: 6 ± 1.8
score, mean
change (95% CI):
G1: -0.2 (-0.8,
Academic
Intervention
setting:
Clinic
Enrollment
period:
NR
Funding:
NIH
Author industry
relationship
disclosures:
NR
Design:
RCT (doubleblind)
minutes
• Previously received G3: 5.7 ± 2 0.4)
Assessments:
secretin
G1/G2/G3: P = 0.75 G2: -0.2 (-0.8,
During 1 week prior to • Any medical condition MacArthur 0.5)
infusion (telephone for which autism was vocabulary score, G3: 0.2 (-0.5, 0.8)
interview) and 4 weeks considered symptomatic mean ± SD: ANOVA: time &
after infusion; Secretin • Had comorbid epilepsy G1: 226.2 ± 242.2 treatment (P =
Outcome Survey (SOS)
• Receiving psychotropic
G2: 225.3 ± 229.4 NS)
and ABC-C at 2 weeks drug Rx 6 months prior
G3: 245.9 ± 228.3 MacArthur
postinfusion and 4 weeks to recruitment
G1/G2/G3: P = 0.93 vocabulary score,
ADOS-G, EOWPVT-R,
• Known allergies to pork
EOW vocabulary mean change
ABC-C
products
score, mean ± SD: (95% CI):
Groups:
G1: 15.2 ± 19.5 G1: 16.5 (-11.7,
• NVIQ < 35
G1: biologic secretin
G2: 14.9 ± 17.6 44.8)
Age, months ± SD:
G2: synthetic secretin
G3: 14.6 ± 15.1 G2: 12.3 (-5.6,
G1: 76.5 ± 25.7 G2: 80.7
G3: placebo
G1/G2/G3: P = 0.99 30.2)
± 29.8 G3: 78.3 ± 24.9
Co-interventions held
Social Skills: G3: 23.4 (9.7,
Mental age, non-verbal
stable during treatment:
ADOS social score, 37.1)
IQ, months ± SD:
NR
mean ± SD: ANOVA: time (P <
Total: 55 ± 13
Frequency of contact
G1: 10 ± 2.0 0.01) treatment (P
Gender:
during study:
G2: 9.8 ± 2.3 = NS)
NR
Telephone interview 1
G3: 9.6 ± 2.1 EOW vocabulary
Race/ethnicity:
week after infusion;
G1/G2/G3: P = 0.78 score, mean
NR
follow-up assessments 4
Problem behavior: change (95% CI):
SES:
weeks after infusion
ABC total score, G1: 1.2 (-0.4, 2.9)
Maternal education: NR
Concomitant therapies:
parent-rated, mean G2: -0.7 (-2.2,
Household income: NR
NR
± SD:
0.7)
Diagnostic approach:
N at enrollment:
G1: 61.4 ± 22.1 G3: 2.1 (0.2, 4.1)
In study
90
G2: 54.2 ± 24 ANOVA: time &
Diagnostic tool/method:
N at follow-up:
G3: 58.9 ± 32 treatment (P =
ADOS-G
Total: 85
G1/G2/G3: P = 0.63 NS)
Diagnostic category, n
G1: 26
ABC total score, Social Skills:
(%):
G2: 26
teacher-rated, mean ADOS social
Autism/PDD-NOS: 85
G3: 33
± SD:
score, mean
(100)
G1: 54.8 ± 22.3 change (95% CI):
Aspergers: NR
G2: 56.4 ± 24.0 G1: 0.0 (-0.9, 0.9)
Other characteristics:
G3: 57.5 ± 20.4 G2: 0.0 (-0.9, 0.9)
NR
G1/G2/G3: P = 0.90 G3: -0.5 (-1.3,
Medical:
0.3)
SOS score, teacher- ANOVA: time &
rated, mean ± SD: treatment (P =
G1: 4.7 ± 1.3
G2: 4.7 ± 1.6
G3: 4.7 ± 1.2
G1/G2/G3: P = 0.99
NS)
Unis et al.,
SOS total score, Problem
2002 (continued)
parent-rated, mean Behavior:
± SD:
ABC total score,
G1: 4.3 ± 1.5 parent-rated,
G2: 4.4 ± 1.5 mean change
G3: 4.0 ± 1.9 (95% CI):
C-386