Study of Toddlers With Language Delay
Condition: Autism; Language Acquisition; Language Development; Toddlers
MeSH terms: Autistic Disorder
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Time perspective: Prospective
Keywords: Autism; Language Acquisition; Language Development; Toddlers