Understanding Sleep Problems in Children With Autism Spectrum Disorder

This is a proposal to study the relationship between melatonin (MT) and sleep problems in
children with autism spectrum disorder (ASD), as part of the collaborative research
structure of the Autism Treatment Network (ATN). A major goal of the ATN is to conduct
clinical research that will have a significant impact on the daily lives and functioning of
individuals with ASD and to address immediate concerns of parents. Children with ASD
experience high rates of sleep disturbance, which likely contribute to the severity of their
daytime cognitive and behavioral dysfunction and to poorer quality of life for them and
their families.

As a step toward addressing sleep problems in ASD, we propose to test the hypothesis that
children with ASD and sleep problems will have a delay in MT onset and/or have decreased MT
secretion over 24 hours compared to normal controls.

Primary endpoint: Characterize the endogenous MT profiles in children with ASD:

We predict that results from this study will reveal lower levels of metabolized MT in
children with ASD when compared to normal children. In addition, we anticipate that children
with ASD will have delayed MT onset or altered circadian phase.

Data from this study will provide important information concerning circadian rhythm
dysregulation in ASD and will support the development of future studies using MT to modify
and correct abnormal circadian rhythms.

Inclusion Criteria:

1. Diagnosis of Autism Spectrum Disorder; supported by ADOS and the ADI or SCQ
(subjects).

2. Age greater than or equal to 4 or less than or equal to 9 years;

3. Parents have given informed consent.

4. Parent/Caregiver fluent in written and spoken English.

5. Controls only: A SCQ score of less than 10 without parental or physician concern for
another neurodevelopmental disorder will be used to define normal children.

Exclusion Criteria:

1. Current use of psychoactive medications (e.g. fluoxetine, methylphenidate,
risperidone, lithium, etc.)*;

2. Current or use within the last 1 month of beta-blockers or melatonin;

3. Current use of sleep aids;

4. Presence of untreated medical problems that could otherwise explain sleep problems
(e.g. obstructive sleep apnea, gastroesophageal reflux disease - GERD);

5. Blindness.

6. Controls only: current or past diagnosis of ADHD, depression, anxiety or with any
other psychiatric conditions. (7) Controls only: Sibling has a diagnosis of Autism
Spectrum Disorder.

- Psychoactive medications can be discontinued but the parents must discuss
medication discontinuation with their prescribing physician prior to reducing or
stopping the medications.