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: Adaptive
Levy et al., Single IV dose of human • Children in the age CARS total score, behavior:
2003
synthetic secretin
range of 3-8 years with mean ± SD: CSBS standard
Country: (2CU/kg) to a maximum ASD as diagnosed by G1: 34.1 ± 3.13 score, period 1,
US
dose of 75 CU injected ADI-R
G2: 37.32 ± 6.23 mean change ±
Practice slowly over 1 minute Exclusion criteria: G1/G2: P = 0.02 SD:
setting:
Infusions separated by a • Significant hearing or CARS score < 37 G1: 0.14 ± 8.28
Academic 6-week washout period vision loss
(mild-moderate), %: G2: -0.27 ± 7.36
Intervention Assessments:
• Other neurological G1: 84
CSBS standard
setting:
GBRS completed by disorders (e.g., cerebral G2: 55
score, period 2,
Clinic
families and teachers or palsy, phenylketonuria, G1/G2: P = 0.003 mean change
Enrollment therapists; daily log of tuberous sclerosis, Adaptive behavior: from BL ± SD:
period:
gastrointestinal symptoms neurofibromatosis, VABS communica- G1: 2.19 ± 7.73
NR
completed by parents; seizure disorder) tion standard score, G2: -0.70 ± 7.90
Funding: CSBS completed by study • Genetic disorder mean ± SD: Ritvo global
NIH, MRDDRC examiners at BL and two • Prematurity (< 32 weeks G1: 54.50 ± 14.03 score, period 1,
Author industry weeks after each infusion; gestation)
G2: 54.44 ± 13.81 mean change ±
relationship Ritvo Real-life Rating
• Diagnosis of coeliac
G1/G2: P = NS SD:
disclosures: Scale completed by study
disease or other CSBS standard G1: 0.01 ± 1.35
NR
examiners at BL and two
gastrointestinal disease, score, mean ± SD: G2: -0.18 ± 0.79
Design: weeks after each infusion;
associated with
G1: 72.75 ± 7.86 Ritvo global
RCT (double-blind occurrence of adverse
malabsorption
G2: 75.03 ± 10.65 score, period 2,
cross-over) effects monitored
• Previous treatment with
G1/G2: P = NS mean change
throughout the study
secretin
Ritvo subscale from BL ± SD:
Groups:
score, mean ± SD: G1: 0.12 ± 0.66
• Anaemia and plumbism
G1: infusion of secretin
Sensory motor: G2: -0.27 ± 0.96
Age, months ± SD:
followed by placebo six
G1: 0.46 ± 0.06 GBRS score,
G1: 70.65 ± 18.2 G2:
weeks later
G2: 0.41 ± 0.06 teacher-rated,
76.53 ± 14.33
G2: infusion of placebo
G1/G2: P = NS period 1, mean
Age, range:
followed by secretin six
Social relatedness: change ± SD:
43-103
weeks later
G1: 1.03 ± 0.06 G1: 0.34 ± 0.72
Mental age:
Co-interventions held
G2:1.16 ± 0.06 G2: 0.14 ± 0.71
NR
stable during treatment:
G1/G2: P = NS GBRS score,
Gender, %:
NR
Affect:
teacher-rated,
Male:
Frequency of contact
G1: 0.64 ± 0.10 period 1, mean
G1: 87
during study:
G2: 0.74 ± 0.10 change ± SD:
G2: 74
Families & teachers or
G1/G2: P = NS G1: 0.33 ± 1.01
Female:
therapists completed
Sensory:
G2: 0.29 ± 1.06
G1: 13
GBRS weekly
G1: 0.61 ± 0.05 GBRS score,
G2: 26
Concomitant therapies,
G2: 0.68 ± 0.05 parent-rated,
Race/ethnicity, %:
n:
G1/G2: P = NS period 1, mean
Caucasian:
Prozac:
Language: change ± SD:
G1: 87
G1: 3*
G1: 0.80 ± 0.04 CARS < 37:
G2: 94
G2: 1
G2: 0.88 ± 0.05 G1: 0.20 ± 0.76
SES:
Adderall:
G1/G2: P = NS (n=25)
Maternal education: NR
G1: 0
G2: 0.30 ± 0.71
Household income: NR
G2: 2
(n=14)
Diagnostic approach:
Risperidone
CARS ≥ 37:
In Study
G1: 1
G1: 0.73 ± 0.60
Diagnostic tool/method:
G2: 0
(n=5)
ADI-R
Guanfacine:
G2: 0.14 ± 0.58
G1: 1*
G2: 2
(n=16)
Levy et al., Methylphenidate: Diagnostic category, n
GBRS score,
2003 (continued) G1: 0
(%):
parent-rated,
G2: 2
Autism: 61 (100)
period 2, mean
N at enrollment: PDD-NOS: NR
change from BL ±
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