Therapies for Children With Autism Spectrum Disorders

Country:
US
Practice
setting:
Clinic
Intervention
setting:
Clinic
Enrollment
period:
NR
Funding:
NR
Author industry
relationship
disclosures:
NR
Design:
Study 1:
Prospec-tive
case series
Study 2: Not
included (N < 30)
weight over 1-2 mins
Assessments:
CARS at baseline and
post injection office visits
Physicians or nurses
assessed GI function,
eye contact, expressive
speech, and receptive
language; parents noted
changes in eye contact,
interpersonal relations,
self-stimulatory behavior,
bowel movement
consistency, toy play,
expressive language/
verbalizations, receptive
language, and overall
behavior with
observational diaries;
observed for 1 hour
post-injection
Groups:
G1: secretin
Co-interventions held
stable during
treatment:
NR
Frequency of contact
during study:
Study 1: 2 times, followup
(3.7 ± 1.4 weeks;
range 3-6 weeks)
Concomitant therapies,
n (%):
Other drug treatments:
45 (80.4)
Antidepressants:
9 (16.1)
CNS stimulants:
9 (16.1)
N at enrollment:
G1: 56
N at follow-up:
G1: 56
Author: Intervention:
Dunn-Geier et al.,
2000
Country:
Canada
Practice
setting:
Academic
Intervention
setting:
Clinic
Enrollment
Single dose of secretin
(test dose 0.1 CU
injected through saline
lock; if no immediate
hyper-sensitivity
occurred after 1 minute,
injection of 2 CU/kg (0.2
ml/kg) to a maximum of
1 vial (75 CU))
Assessments:
Autism Behavior Check-
disorder
G1: 36.5 ± 6.4
Exclusion criteria:
• See inclusion criteria
Age, years ± SD:
6.4 ± 2.7
Mental age:
NR
Gender, n (%):
Male: 49 (88)
Female: 7(13)
Race/ethnicity:
NR
SES:
Maternal education: NR
Household income: NR
Diagnostic approach:
Self-Referral
Diagnostic tool/method:
DSM-IV
Diagnostic category, n
(%):
Autism: 22 (40)
PDD-NOS: 34 (60)
Other characteristics, n
(%):
GI distress: 33 (59)
Abnormal EEG: 31 (63)
Inclusion criteria:
• Diagnosis of autism
based on behavioral
observation of the child
and semistructured
interview with the
parent (CARS score ≥
30)
• Score of ≥ 6 on DSM-
IV criteria for autism
• Clinical judgment by a
development
C-409
Overall ratings:
CARS score, mean
± SD:
G1: 38.5 ± 4.5
G2: 37.9 ± 4.4
Autism Behavior
Checklist, total
score, mean ± SD:
G1: 79.0 ± 31.6
G2: 79.9 ± 26.9
Autism Behavior
Checklist body and
G1: 33.2 ± 5.4
G1/BL: P < 0.01
CARS score,
decrease from
baseline, n:
≥ 6 (clinically
meaningful): 13
1 to 5.5: 32
0 (no change): 2
-0.5 to -11
(worsening): 9
Social skills, n
(%):
Improved eye
contact: 19 (34)
Communication
/ language, n
(%):
Improved expressive
language:
30 (34)
Receptive
speech
improvements:
15 (27)
Improvements in
expressive
speech: 30 (54)
Improvements in
receptive
speech: 15 (27)
Worsening of
expressive
speech: 1 (1.8)
Medical, n (%):
Improved GI: 19
(34)
Worsening of GI
function & eye
contact: 1 (1.8)
Harms:
Reports of increased
agitation,
decreased focusing
& decreased
responsiveness
to others
Modifiers:
NR
Overall ratings:
CARS score, mean
change (SE):
G1: -1.2 (0.3)
G2: -1.5 (0.4)
G1/G2: P = 0.62
Autism Behavior
Checklist, total score,
mean change (SE):
G1: -13.1 (2.6)
G2: -14.0 (2.7)
G1/G2: P = 0.81