Therapies for Children With Autism Spectrum Disorders

Evidence Table. Therapies for children with ASD
Study
Inclusion/Exclusion
Description Intervention
Criteria/Population
Author:
Intervention:
Inclusion criteria:
Kern et al., Oral dimethylglycine, 125 • Met the DSM-IV
2001
mg/day (placebo group diagnostic criteria for
Country: received mannitol tablets autism or PDD
US
of the same size and Exclusion criteria:
Practice
setting:
frequency)
Titration by weight:
• See inclusion criteria
Age, years (range):
Community
Intervention
< 40 lbs: 1 tablet
41-70 lbs: 2 tablets
NR (3-11)
Mental age:
setting:
71-100 lbs: 3 tablets NR
Clinic
101-130 lbs: 4 tablets Gender:
Enrollment
period:
> 131 lbs: 5 tablets
Assessments:
NR
Race/ethnicity:
NR
Funding:
Neurological and
behavioral assessments
NR
SES:
FoodScience performed in childcare Maternal education: NR
Corporation
Author industry
room at University of
Dallas with toys and
Household income: NR
Diagnostic approach:
relationship
disclosures:
activity centers; a variety In Study
of items were available to Diagnostic tool/method:
NR
Design:
use during the behavioral DSM-IV
observations, such as Diagnostic category, n
Double-blind, wooden blocks, crayons, (%):
randomized pencils, paper, and balls; Autistic or PDD-NOS: 37
controlled trial parents were present (100)
Behavioral: VABS Other characteristics, n
maladaptive behavior (%):
domain, ABC subscales I- Gross/fine motor skill
V; obtained at baseline delay: 26 (70)
and 4 weeks post treat- Problems with gross/fine
ment; videotaped ocular pursuit: 4 (11)
Neurologic: examination Poor muscle tone: 5 (14)
of coordination, posturing, Non-verbal: 10 (27)
toe walking
Echolalic: 12 (32)
Groups:
G1: dimethylglycine
G2: placebo
Co-interventions held
stable during treatment,
n:
Yes
Difficulty sleeping: 16 (43)
Eating disorders: 16 (43)
Hyperlexia: 4 (11)
Kern et al.,
2001 (continued)
Frequency of contact
during study:
Participants met with
investigators at baseline
and 4 weeks after
treatment began
Concomitant therapies:
Psychoactive medication
(clonidine, thioridazine,
paroxetine, imipramine,
methylphenidate, &
fluoxetine): 7
N at enrollment:
C-397
Baseline
Measures Outcomes
Problem behavior: Overall ratings:
VABS maladaptive Main behavioral
behavior score, effect change,
mean:
mean (range
G1: NR
across all assess-
G2: NR
ment methods):
G1/G2: P < 0.35 G1: 0.71 (0.06,
ABC irritability and 1.94)
self-abusive G2: 0.87 (0.32,
behavior score, 1.68)
mean:
G1/G2: P = NS
G1: NR
Parent report of
G2: NR
treatment effect, n
G1/G2: P < 0.46 (%):
Social skills: Positive response:
ABC lethargy, social G1: 11 (58)
withdrawal, and G2: 10 (53)
withdrawal score, Negative
mean:
response:
G1: NR
G1: 3 (16)
G2: NR
G2: 6 (32)
G1/G2: P < 0.0003 No response:
Repetitive G1: 5 (26)
behavior:
G2: 3(16)
ABC stereotypic Social skills:
behavior score, ABC lethargy,
mean:
social withdrawal,
G1: NR
and withdrawal
G2: NR
score, mean
G1/G2: P < 0.58 change (%
ABC hyperactivity improvement):
score, mean: G1: 1.94 (15.3)
G1: NR
G2: 0.95 (13.6)
G2: NR
G1/G2: P < 0.12
G1/G2: P < 0.35 Communication/
Communication/ language:
language: ABC inappropriate
ABC inappropriate speech score,
speech score, mean change:
mean:
G1: NR
G1: NR
G2: NR
G2: NR
G1/G2: P = NS
G1/G2: P < 0.84 Repetitive
Neurologic behavior:
assessments: ABC stereotypic
Standard neuro- behavior score,
logical exam, n: mean change:
G1: 17
G1: NR
G2: 16
G2: NR
G1/G2: P = NS
ABC hyperactivity
score, mean
change:
G1: NR
G2: NR
G1/G2: P = NS
Problem