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 measures:
Owley et al., Porcine secretin or saline • Diagnosis of autism CGI-S score, mean CGI-S score, week 4,
2001
placebo 2 CU/kg infused confirmed in study ± SD:
mean ± SD:
Country: at baseline or end of week • For subjects younger G1: 3.0 ± 0.8 G1: 2.9 ± 0.8
US
4, injected over 1 minute than 5, non verbal ratio G2: 2.8 ± 0.8 G2: 2.7 ± 0.9
Practice Assessment:
IQ > 20 according to GARS autism GARS autism quotient,
setting:
DAS; MSEL for children Mullen Scales of Early quotient, mean ± week 4, mean ± SD:
Academic under 5 and those for Learning
SD:
G1: 86.9 ± 13.2 (n=26)
Intervention which a basal could not • For subjects with non G1: 93.6 ± 12.0 G2: 82.5 ± 15.2
setting:
be established on
verbal IQ 20-34, VABS (n=26)
Social skills:
Clinic
subtests of the DAS; age equivalent of ≥ 24 G2: 86.5 ± 11.7 ADOS social interaction
Enrollment DTVP-II, ADOS, PPVT-III months
(n=27)
score, week 4, mean ±
period:
(> 5 years and able to Exclusion criteria: G1/G2: P = 0.03 SD:
NR
establish basal)
• History of allergy to Social skills: G1: 11.5 ± 1.5
Funding: VABS Interview Edition porcine products ADOS social G2: 10.1 ± 1.8
UC Davis MIND and CGI scales at • Significant history of interaction score, GARS social interaction
Institute, NIH, baseline and end of illness including mean ± SD: score, week 4, mean ±
Jean Young and weeks 4 and 8, GARS nonfebrile seizures and G1: 11.9 ± 1.5 SD:
Walden Shaw and ABC-C at baseline excluding autism G2: 10.8 ± 1.9 G1: 7.3 ± 2.7
Foundation, Irving and end of weeks 2, 4, 6, Age, months ± SD: G1/G2: P < 0.018 G2: 6.2 ± 2.5
Harris Foundation and 8
G1: 79.6 ± 21.8
GARS social ADOS play score, week
Author industry Groups:
G2: 81.4 ± 24.4
interaction score, 4, mean ± SD:
relationship G1: secretin first, followed Mental age:
mean ± SD: G1: 2.7 ± 1.3
disclosures: by placebo
Non-verbal IQ, mean ± SD: G1: 8.4 ± 2.4 (n=26) G2: 2.0 ± 1.4
NR
G2: placebo first, followed G1: 55.9 ± 24.5
G2: 6.9 ± 2.2 (n=27) Vineland sociali-zation
Design: by secretin
G2: 56.9 ± 19.4
G1/G2: P = 0.02 score, week 4, mean ±
Multisite double- Co-interventions held Gender, n (%):
ADOS play score, SD:
blind, parallel stable during treatment: Male:
mean ± SD: G1: 34.6 ± 17.9
group RCT Yes
G1: 24 (85.7)
G1: 2.6 ± 1.6 G2: 39.3 ± 18.4
crossover design Frequency of contact G2: 24 (85.7)
G2: 2.2 ± 1.5 Communication/
during study:
Female:
Vineland socializa- language:
Baseline and assess- G1: 4 (14.3)
tion score, mean ± ADOS Communi-cation
ments at week 4 (primary G2: 4 (14.3)
SD:
score, wwek 4, mean ±
outcome) and week 8 Race/ethnicity, n (%): G1: 35.5 ± 18.0 SD:
(crossover assessment) African American: G2: 39.5 ± 19.2 G1: 6.5 ± 1.7
Concomitant therapies, G1: 1 (3.6)
Communication/ G2: 6.3 ± 2.2
n:
G2: 3 (10.7)
language: ADOS communi-cation
SSRI: 3
Hispanic:
ADOS communica- + social interaction
Atypical neuroleptics: 3 G1: 2 (7.1)
tion score, mean ± scores, week 4, mean ±
Alpha adrenergic agonist: G2: 4 (14.3)
SD:
SD:
1
Asian:
G1: 6.8 ± 1.8 G1: 18.1 ± 2.5
Psychostimulants: 8 G1: 1 (3.6)
G2: 6.5 ± 2.1 G2: 16.4 ± 3.5
N at enrollment: G2: 0
ADOS communi- GARS commu-nication
G1: 28
White:
cation + social score, week 4, mean ±
G2: 28
G1: 24 (85.7)
interaction scores, SD:
N at follow-up:
G2: 21 (75)
mean ± SD: G1: 9.2 ± 3.0 (n=22)
G1: 28
SES:
G1: 18.7 ± 3.7 G2: 8.0 ± 3.3
G2: 28
Maternal education: NR G2: 17.3 ± 3.5
Household income: NR
Diagnostic approach:
In Study
Owley et al.,
Diagnostic tool/method: GARS communica- Mullen/DAS/PPVT/DTV
2001 (continued)
ADI-R, ADOS confirmed tion score, mean ± P-2 receptive language
with DSM-IV diagnosis SD:
score, week 4, months
Diagnostic category, n G1: 9.5 ± 2.7 (n=22) ± SD:
(%):
G2: 8.5 ± 2.4 (n=27) G1: 29.1 ± 21.8
Autistic disorder:
Mullen/DAS/PPVT/ G2: 40.1 ± 31.6
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