Therapies for Children With Autism Spectrum Disorders

Evidence Table. Therapies for children with ASD (continued)
Study
Inclusion/ Exclusion Baseline
Description Intervention
Criteria/ Population Measures Outcomes
Clinic
started on 1.5 mg and Exclusion criteria: insomnia: 68 (60)**
Enrollment increased to 3 mg after 2 • Comorbid childhood Early awakening: 1 Sleep still a major
period:
weeks if no response bipolar disorder Medication-free at concern: 14 (13)
NR
All children who did not Age, years (range): baseline, n (%):* Worse sleep after
Funding: show a response after 4 NR (2-18)
45 (42)
melatonin: 1 (1)
NR
weeks were increased to Mental age:
Undetermined
Author industry 6 mg
NR
response: 1 (1)
relationship Sleep hygiene techniques Gender, %:
Harms:
disclosures: were suggested with start Male: 80
Morning
None
of melatonin
Female: 20
sleepiness,
Design: Assessments:
Race/ethnicity, %:
fogginess,
Retrospective Parent report in medical Caucasian: 60
increased
case series chart; children were from African American: 6
enuresis, n: 3
a single pediatrician’s Race unknown: 34
Modifiers:
practice (specializing in SES:
No significant
ASD)
Maternal education: NR
difference in
Groups:
Household income: NR
melatonin
G1: melatonin (dose Diagnostic approach:NR
response between
range: 0.75-6.0 mg) Diagnostic tool/method:
medication-free
Measure of treatment Chart review, based on
before taking
fidelity reported: DSM-IV criteria
melatonin vs.
Parental compliance with Diagnostic category, %:
prescribed
sleep hygiene techniques Autistic disorder: 71
psychotropic
documented in 65 (58%) PDD-NOS: 19
medication.
children
Aspergers: 5
Co-interventions held Other characteristics, n
stable during treatment: (%):
NR
Epileptic seizures: 21 (20)
Frequency of contact Refractory epilepsy: 4 (4)
during study:
Comorbid psychiatric
2-6 month intervals for an diagnoses, including
average of 1.8 ± 1.4 years ADHD, OCD, depression,
after initiating melatonin ODD, anxiety: 31 (29)
(18 children had only 1 Mean age at onset of sleep
documented follow-up problems, years ± SD:
visit after initiation of 6.7 ± 3.8
melatonin)
Mean age at start of
melatonin, years ± SD:
8 ± 3.9
Andersen et al., Concomitant therapies,
2008 (continued) n (%):
Any psychotropic
medication use: 96 (90)
Antidepressants: 60 (56)
Antipsychotics: 68 (64)
Sedative/hypnotics: 50
(45)
Antiepileptics: 36 (34)
Stimulants: 46 (43)
N at enrollment:
G1: 107
N at follow-up:
G1: 107
Comments: *34 of these 45 children started psychotropic medication within 2-6 months after initiation of melatonin.
**7 initially reported improvement, but sleep problems returned after 3-12 months
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