Autism Clinical Trial
Official title:
Markers of Autism Spectrum Disorders in At-Risk Toddlers: A Pilot Study
The purpose of this study is to learn more about risk factors for autism by studying the behavior and brain functioning of toddlers with early communication delays and typically developing toddlers. Children 12 or 18 months of age with language delays (i.e., no words at 18 months, limited vocalizations at 12 months) and typically developing toddlers may be eligible to participate. This study will be conducted at the NIH Clinical Center in Bethesda, Maryland. There will be an initial screening evaluation that will include behavioral assessment. Eligible participants will then complete a baseline visit that includes an overnight sleep study that includes Electroencephalogram (EEG) test to measure brain electrical activity, and an MRI scan. Follow-up visits that include behavioral assessment will occur every 6-12 months, depending on age at study entry. The final study visit will occur at 36 months of age and will include behavioral assessment, sleep/EEG study, and MRI. There is no cost for participation. Compensation will be provided. To find out if your child qualifies or for more information, please call 301-451-7822 (TTY: 1-866-411-1010) or e-mail NIMH-ASD@mail.nih.gov. National Institute of Mental Health, National Institutes of Health, Department of Health & Human Services.
Objective
This investigation will focus on two areas: 1) early communication impairments as predictors
of autism spectrum disorder (ASD) and later developmental delays, and 2) the relationship
between communication and evidence of CNS function (sleep, EEG) and structure (MRI DTI and
volumetrics) in young children at risk for ASD. The objective is to delineate early
communicative impairments that predict ASD vs. other developmental delays and to examine how
these impairments correlate with brain abnormalities in both structure and function.
Study Population
We will recruit 64 children [n=32 at 12 months of age (plus or minus 2 months); n=32 at 18
months of age (plus or minus 2 months)] who are at-risk for ASD due to communication/language
delays (at-risk group). The at-risk children will be matched at initial on chronological age,
SES, and sex, to typically developing children (n=75) with no history of developmental
delays. These 139 participants will hereafter be referred to as the toddler sample. At the 36
month final visit, diagnostic status (e.g. ASD, non-ASD specific delays, catch up) will be
determined for children in the at-risk group. In addition, 10 healthy adults, aged 18-40 will
serve as control participants for the purpose of piloting the functional paradigms for the
MRI portion of the protocol.
Design
We propose to conduct a prospective, longitudinal study of toddlers at-risk for ASD compared
to typically developing toddlers. Children will complete behavioral testing and an overnight
Sleep/EEG as well as MRI at either a 12 or 18 month initial. Follow-up visits that include
behavioral assessment will occur at 24 and 36 months for all children (and at 18 months of
age for the 12-month cohort). The Sleep/EEG and MRI will be repeated at the 36 month final
follow-up.
Outcome Measures
Autism symptoms, language status, and cognitive development at 36 months will serve as the
primary outcome measures.
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