Therapies for Children With Autism Spectrum Disorders

Evidence Table. Therapies for children with ASD (continued)
Study
Description Intervention
Reed et al., 2009
(continued)
Inclusion/ Exclusion
Criteria/ Population
Comments: *The authors reported no improvement on other subscales of the RBS.
Author:
Rossignol et al.,
2009
Country:
US
Practice
setting:
Specialty
Intervention
setting:
Clinic
Enrollment
period:
NR
Funding:
International
Hyperbarics
Association
Author industry
relationship
disclosures:
8 of 11
Clinicians deriving
revenue from
hyperbaric
treatment (8)
International
Hyperbaric
Association (3)
OxyHealth (1)
Design:
Prospective RCT
(Double-blind, Rx
in parallel groups)
Intervention:
40 sessions of 1 hourlong
hyperbaric treatments
at 1.3 atm and 24%
oxygen
Controls received 40
hour-long treatments in
slightly pressurized air
(1.03 atm) and 21%
oxygen
Groups:
G1: hyperbaric treatment
G2: control
Assessments:
ABC, ATEC, CGI
Co-interventions held
stable during treatment:
Yes
Frequency of contact
during study:
40 sessions for each
group: twice a day, 5
days/week for 4
consecutive weeks
Concomitant therapies,
n (%):
Nutritional supplements,
medications:
G1: 23/33
G2: 20/29
ABA therapy:
G1: 15/33
G2: 11/29
Medications:
G1: 16/33
G2: 10/29
G1/G2: P = NS
Children not allowed to
Inclusion criteria:
• Autistic disorder
• Ages 2-7 years
• No previous hyperbaric
treatment
Exclusion criteria:
• Aspergers, PDD-NOS
• Seizure disorder, current
ear infection,
uncontrolled asthma,
inability to equalize ear
pressure, fragile X,
ongoing chelation
treatment
Age, yrs ± SD (range):
Total: 4.92 ± 1.21 (2-7)
G1: 4.97 ± 1.29 (NR)
G2: 4.86 ± 1.13 (NR)
Mental age, mean/yrs
(range): NR
Gender, n (%):
Male:
G1: 30 (90.9)
G2: 22 (75.9)
Female:
G1: 3 (9.1)
G2: 7 (24.1)
Race/ethnicity:
NR
SES:
Maternal education: NR
Household income: NR
Diagnostic approach:
Referral diagnosis of
autistic disorder
Diagnostic tool/method:
ADOS and ADI-R, plus
C-95
Baseline
Measures Outcomes
issues score,
mean ± SD:
G1: 2.70 ± 0.73
G1/BL: P = NS
Harms:
NR
Modifiers:
The PPVT
receptive
language score
did not correlate
significantly with
either the total or
modified total
Children’s Sleep
Habits Questionnaire
score
Overall ratings:
ABC total score,
mean ± SD:
G1: 55.2 ± 28.7
G2: 53.3 ± 24.0
ATEC total score,
mean ± SD:
G1: 75.3 ± 19.5
G2: 75.6 ± 21.0
Social skills:
ABC social
withdrawal score,
mean ± SD:
G1: 10.5 ± 6.9
G2: 11.2 ± 6.9
ATEC sociability
score, mean ± SD:
G1: 17.4 ± 6.6
G2: 17.8 ± 6.2
Communication/
language:
ABC speech score,
mean ± SD:
G1: 3.4 ± 3.1
G2: 3.6 ± 3.6
ATEC speech/
language/commu-
nication score,
mean ± SD:
G1: 16.3 ± 5.0
G2: 15.9 ± 6.1
Repetitive
behavior:
ABC stereotypy
score, mean ± SD:
G1: 7.5 ± 4.9
G2: 6.2 ± 4.7
Problem behavior:
Overall ratings:
CGI score,
clinician-rated,
mean ± SD:
G1: 2.87 ± 0.78
G2: 3.62 ± 0.75
G1/BL: P =
0.0008
G2/BL: P = NS
CGI score,
clinician-rated, n
(%):
1 or 2:
G1: 9/30 (30)
G2: 2/26 (7.7)
(P = 0.0471)
1/2/3:
G1: 24/30 (80)
G2: 10/26 (38)
(P = 0.0024)
4/5:
G1: 6/30 (20)
G2: 16/26 (62)
(P = 0.0024)
5:
G1: 0
G2: 2/26 (7.7)
G1/G2: P = 0.211
Significant
improvement in
G1 compared to
G2 in CGI
subscales,
Receptive
language (P