Therapies for Children With Autism Spectrum Disorders

Evidence Table. Therapies for children with ASD (continued)
Study
Inclusion/ Exclusion Baseline
Description Intervention
Criteria/ Population Measures Outcomes
NR
glutathione lotion • No liver or kidney G2: 93.8 ± 29.5 ± SD:
Author industry received DSMA, those disease
REXSCA/C G1: 79.5 ± 49.9
relationship
disclosures:
who received placebo • Well hydrated
lotion received placebo Phase II:
composite (social G2: 71.6 ± 38.8
approach + express + G1/BL: P <
None
Design:
RCT
in Phase II
• Excretion of high LMRL), mean ± SD: 0.001
• All participants received amounts of toxic metals G1: 127 ± 52.7 G2/BL: P <
vitamin/mineral
in Phase I
(n=25)
0.001
supplements for ≥ 2 • Normal liver function G2: 135 ± 65.5 REXSCA/C
months prior to and (serum transaminases Autism composite composite:
through the study ALT and AST), normal (sensory + ritual + G1: 139 ± 54.5
period
renal function, and social problems – G2: 150 ± 53.6
Duration:
complete blood cell social approach G1/BL: P < 0.01
NR
count was not below the behaviors – G2/BL: P < 0.05
Frequency:
normal reference range expressive
Autism
NR
• No changes in
language), mean ± composite:
Assessments:
medication,
SD:
G1: -73.3 ± 67.9
Phase I: ATEC and Heavy supplements, diet, or G1: -53.1 ± 66.4 G2: -88.8 ± 58.3
Metal Exposure Question- behavioral interventions (n=25)
G1/BL: P < 0.01
naire completed by during the study G2: -63.5 ± 65.1 G2/BL: P < 0.01
parents at baseline • At least a two-month
SAS score, phase 1 SAS score, com-
Phase II: ADOS
history of taking a multi-
onset, mean ± SD: pletion of phase
administered by clinician vitamin/mineral
G1: 5.2 ± 2.2) 2, mean ± SD:
following the completion supplement with a least
G2: 5.5 ± 2.7) G1: 4.2 ± 2
of Phase I (at onset and the RDA of zinc, and
Social skills: G2: 4.5 ± 2.6
completion of Phase II); continuing to take that
ATEC Sociability, G1/BL: P <
parent completed the during Phase II
mean ± SD: 0.001
PDD-BI and SAS (at
• Continue to stay well
G1: 16.6 ± 8.5 G2/BL: P < 0.01
onset and completion of
hydrated
G2: 14.9 ± 6.8 Social skills:
Phase II); Parental Global Exclusion criteria:
PDD-BI Social ATEC
Impressions questionnaire
pragmatic problems, Sociability, mean
• See inclusion criteria
(post-treatment only,
mean ± SD: ± SD:
Age, years:†
answers range from -3
G1: 16.9 ± 9.2 (n=25) G1: 12.1 ± 6.5
G1: 6.7
“much worse” to +3 “much
G2: 13.9 ± 7.5 G2: 11.2 ± 6.5
G2: 6.5
better”); clinician working
G1/BL: P <
Mental age:
with child to complete
0.001
NR
ATEC for the child (post-
G2/BL: P < 0.05
treatment only)
Adams et al., Groups:
Gender, n:†
AWP/C Social PDD-BI Social
2009 (A) G1: treatment (7 rounds Male:
approach behaviors, pragma-tic
Adams et al., of treatment)
G1: 24
mean ± SD: problems, mean
2009 (B)† G2: placebo (1 round G2: 14
G1: 63.8 ± 20.6 ± SD:
(continued) of treatment followed by 6 Female:
(n=25)
G1: 14.5 ± 9.2
rounds of placebo) G1: 2
G2: 68.2 ± 25.4 G2: 9.9 ± 7.5
Provider(s):
G2: 1
ADOS Sociability, G1/BL: P = NS
NR
Race/ethnicity:
mean:
G2/BL: P < 0.01
Measure of treatment NR
G1: 9.3
AWP/C Social
fidelity reported: SES:
G2: 8.1
approach
Yes
Maternal education: NR ADOS
behaviors, mean
Co-interventions held Household income: NR Communication + ± SD:
stable during treatment: Diagnostic approach: sociability, mean: G1: 70.8 ± 23.6
NR
Referral
G1: 17
G2: 72.6 ± 20.2
Concomitant therapies: Diagnostic tool/method: G2: 14.7
G1/BL: P < 0.01
NR
Initially diagnosed by
G2/BL: P = NS
N at enrollment: community clinicians Communication/ ADOS
Phase 1: 82
independent of this study, language:
Sociability, mean
Phase 2 :49
confirmed by ADOS- PDD-BI
(% change):
N at follow-up:
certified evaluator Semantic/pragmatic G1: 8.3 (-10)
C-28