Study of Toddlers With Language Delay (NCT01339767) | Clinical Trial Compass
CompletedNot Applicable
Study of Toddlers With Language Delay
United States77 participantsStarted 2011-04-18
Plain-language 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.
Who can participate
Age range9 Months – 21 Months
SexALL
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Inclusion criteria
✓. 12 or 18 months of age (plus or minus 3 months)
✓. Limited spoken words (for both the 12 and 18 month groups)
✓. Expressive and Receptive scores in the Very Low range on the Mullen Scales of Early Learning (a standardized observational measure),
✓. 12 or 18 months of age (plus or minor 3 months)
✓. Development in nonverbal and verbal areas within age expectations (per scores on all 4 domains of the Mullen Scales of Early learning no more than 1.5 standard deviation below the mean).
Exclusion criteria
✕. Primary language spoken in the home is other than English
✕. Prematurity at birth (defined as less than 36 weeks gestation), or birth weight significantly below normal for gestational age (SGA- small for gestational age) or other significant birth trauma.
✕. Motor or other medical impairment deemed responsible for delays (e.g. cerebral palsy; known genetic disorder)
. Primary language spoken in the home is other than English
✕. Prematurity at birth (defined as less than 36 weeks gestation); or birth weight significantly below normal for gestational age (SGA- small for gestational age).
✕. Motor or other medical impairment that would interfere with study participation
✕. Known genetic disorder
✕. Status as a younger sibling of a child diagnosed with autism