Kern et al., 2001

Study DescriptionInterventionInclusion/Exclusion
Criteria/Population
Baseline MeasuresOutcomes
Author:
Kern et al., 2001
Country:
US
Practice setting:
Community
Intervention setting:
Clinic
Enrollment period:
NR
Funding:
FoodScience Corporation
Author industry relationship disclosures:
NR
Design:
Double-blind, randomized controlled trial
Intervention:
Oral dimethylglycine, 125 mg/day (placebo group received mannitol tablets of the same size and frequency)
Titration by weight:
< 40 lbs: 1 tablet
41–70 lbs: 2 tablets
71–100 lbs: 3 tablets
101–130 lbs: 4 tablets
> 131 lbs: 5 tablets
Assessments:
Neurological and behavioral assessments performed in childcare room at University of Dallas with toys and activity centers; a variety of items were available to use during the behavioral observations, such as wooden blocks, crayons, pencils, paper, and balls; parents were present Behavioral: VABS maladaptive behavior domain, ABC subscales I-V; obtained at baseline and 4 weeks post treatment; videotaped
Neurologic: examination of coordination, posturing, toe walking
Groups:
G1: dimethylglycine
G2: placebo
Co-interventions held stable during treatment, n:
Yes

Frequency of contact during study:
Participants met with investigators at baseline and 4 weeks after treatment began
Inclusion criteria:
  • Met the DSM-IV diagnostic criteria for autism or PDD
Exclusion criteria:
  • See inclusion criteria
Age, years (range):
NR (3–11)
Mental age:
NR
Gender:
NR
Race/ethnicity:
NR
SES:
Maternal education: NR
Household income: NR
Diagnostic approach:
In Study
Diagnostic tool/method:
DSM-IV
Diagnostic category, n (%):
Autistic or PDD-NOS: 37 (100)
Other characteristics, n (%):
Gross/fine motor skill delay: 26 (70)
Problems with gross/fine ocular pursuit: 4 (11)
Poor muscle tone: 5 (14)
Non-verbal: 10 (27)
Echolalic: 12 (32)
Difficulty sleeping: 16 (43)
Eating disorders: 16 (43)
Hyperlexia: 4 (11)
Problem behavior:
VABS maladaptive behavior score, mean:
G1: NR
G2: NR
G1/G2: P < 0.35
ABC irritability and self-abusive behavior score, mean:
G1: NR
G2: NR
G1/G2: P < 0.46
Social skills:
ABC lethargy, social withdrawal, and withdrawal score, mean:
G1: NR
G2: NR
G1/G2: P < 0.0003
Repetitive behavior:
ABC stereotypic behavior score, mean:
G1: NR
G2: NR
G1/G2: P < 0.58
ABC hyperactivity score, mean:
G1: NR
G2: NR
G1/G2: P < 0.35
Communication/language:
ABC inappropriate speech score, mean:
G1: NR
G2: NR
G1/G2: P < 0.84
Neurologic assessments:
Standard neurological exam, n:
G1: 17
G2: 16
Overall ratings:
Main behavioral effect change, mean (range across all assessment methods):
G1: 0.71 (0.06, 1.94)
G2: 0.87 (0.32, 1.68)
G1/G2: P = NS
Parent report of treatment effect, n (%):
Positive response:
G1: 11 (58)
G2: 10 (53)
Negative response:
G1: 3 (16)
G2: 6 (32)
No response:
G1: 5 (26)
G2: 3(16)
Social skills:
ABC lethargy, social withdrawal, and withdrawal score, mean change (%improvement):
G1: 1.94 (15.3)
G2: 0.95 (13.6)
G1/G2: P < 0.12
Communication/language:
ABC inappropriate speech score, mean change:
G1: NR
G2: NR
G1/G2: P = NS
Repetitive behavior:
ABC stereotypic behavior score, mean change:
G1: NR
G2: NR
G1/G2: P = NS
Concomitant therapies:
Psychoactive medication (clonidine, thioridazine, paroxetine, imipramine, methylphenidate, & fluoxetine): 7
N at enrollment:
G1: 20
G2: 19
N at follow-up:
G1: 18
G2: 19
ABC hyperactivity score, mean change:
G1: NR
G2: NR
G1/G2: P = NS
Problem behavior:
VABS maladaptive behavior score, mean change:
G1: NR
G2: NR
G1/G2: P = NS
ABC irritability and self-abusive behavior score, mean change:
G1: NR
G2: NR
G1/G2: P = NS
Motor skills:
Improved gross motor function, neurologic assessment, n:
G1: 3/17
G2: 0/16
G1/G2: P = 0.57
Harms, n (%):
Hyperactivity:
G1: 2 (11)
G2: 4 (21)
Increased aggression:
G1: 1 (5)
G2: 2 (11)
Difficulty sleeping:
G1: 1 (5)
G2: 2 (11)
Any negative effects, %:
G1: 16
G2: 32
Withdrawn due to adverse behavioral changes, n:
Total: 1
Modifiers:
NR

From: Appendix C, Evidence Tables

Cover of Therapies for Children With Autism Spectrum Disorders
Therapies for Children With Autism Spectrum Disorders.
Comparative Effectiveness Reviews, No. 26.
Warren Z, Veenstra-VanderWeele J, Stone W, et al.

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