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 ratings:
Molloy et al., IV Synthetic Human • 2-15 years of age CARS score, mean CARS score,
2002
Secretin (2IU/kg at the • Autism criteria met as ± SD:
week 12, mean ±
Country: first visit, followed by per DSM-IV following a G1: 40.2 ± 5 SD:
US
equal volume of saline multidisciplinary G2: 39.2 ± 5.6 G1: 40.2 ± 4.9
Practice placebo at week 6); other evaluation
G1/G2: P = NS G2: 38.6 ± 5
setting:
group in the reverse order • Diagnosis by
GARS autism G1/BL: P = NS
Academic
developmental quotient, mean ± G1/BL: P = NS
Intervention Assessments:
pediatrician if from SD:
G1/G2: P = NS
setting:
Participants evaluated on outside this center G1: 102 ± 7.9 GARS autism
Clinic
5 occasions: baseline Exclusion criteria: G2: 98.6 ± 9.2 quotient week 12,
Enrollment prior to first infusion, week • Chromosomal/genetic G1/G2: P = NS mean ± SD:
period:
3, week 6 prior to cross- disorders
Communication/ G1: 98.1 ± 8.4
NR
over infusion, & weeks 9 • Structural abnormality on language: G2: 94.9 ± 8.3
Funding: and 12; each evaluation neuroimaging
Merrill-Palmer scale, G1/BL: P = NS
NIH
took place in same room • Acute or chronic
mean ± SD: G1/BL: P = NS
Author industry & included CARS, GARS,
pancreatic disease
G1: 22.1 ± 28.5 G1/G2: P = NS
relationship & DTVP or selected tests
G2: 30.1 ± 34.6 Communication/
• Any medical condition
disclosures: of MPS all administered
that makes participation
G1/G2: P = NS language:
NR
by a clinical psychologist
unsafe
Mullen receptive Merrill-Palmer
Design: Parents completed ABC
Age, months ± SD:
language score, scale, week 12,
RCT (double-blind and the Autism Behavior
G1: 83.5 ± 32.4
mean ± SD: mean ± SD:
cross-over trial) Checklist, which were
G2: 80.7 ± 30.7
G1: 18.3 ± 10.5 G1: 29.5 ± 39.6
interpreted by the clinical
Mental age:
G2: 18.5 ± 11.5 G2: 40.1 ± 34.8
psychologist; parents
G1/G2: P = NS G1/BL: P = NS
NR
were asked about stool
Gender, n (%):
PPVT score, mean G1/BL: P = NS
patterns at each visit, as
Male:
± SD:
G1/G2: P = NS
well as inter-current
G1: 17 (89.5)
G1: 10 ± 22.4 Mullen receptive
illnesses, medical prob-
G2: 20 (87)
G2: 13.3 ± 25.1 language score,
lems and medications,
G1/G2: P = NS
Female:
week 12, mean ±
and adverse events
G1: 2 (10)
Utterance, mean SD:
Receptive language skills
G2: 3 (13)
length ± SD: G1: 19.5 ± 10.4
evaluated by team of two
Race/ethnicity, n (%):
G1: 1.10 ± 1.09 G2: 21.1 ± 11
speech & language
G2: 1.06 ± 1.04 G1/BL: P = NS
Caucasian:
pathologists using PPVT-
G1: 15 (79)
G1/G2: P = NS G1/BL: P = NS
III & Receptive Language
G2: 17 (74)
Type token ratio, G1/G2: P = NS
Scale of MSEL
SES:
mean ± SD: PPVT score,
Expressive language
G1: 0.42 ± 0.41
Maternal education: NR
week 12, mean ±
abilities assessed at each
Household income: NR
G2: 0.45 ± 0.41 SD:
visit using 15-minute
Diagnostic approach:
G1/G2: P = NS G1: 14.2 ± 24.1
videotaped sample of
In study
G2: 16.9 ± 27.3
spontaneous language
Diagnostic tool/method:
G1/BL: P = NS
during play with caregiver
DSM-IV
G1/BL: P = NS
Clinical lab evaluation
Diagnostic category, n
G1/G2: P = NS
obtained before each
(%):
Utterance, week
infusion and at week 12
Autism: 42 (100%)
12, mean length ±
Groups:
PDD-NOS: NR
SD:
G1: secretin first, followed
Aspergers : NR
G1: 0.82 ± 1.11
by placebo
Other characteristics:
G2: 0.94 ± 1.07
G2: placebo first, followed
G1/BL: P = NS
NR
by secretin
G1/BL: P = NS
G1/G2: P = NS
Molloy et al., Co-interventions held
Type token ratio,
2002 (continued) stable during treatment:
week 12, mean ±
NR
SD:
Frequency of contact
G1: 0.22 ± 0.31
during study:
G2: 0.31 ± 0.3
C-380