Study of Toddlers With Language Delay

Completed

Conditions studied: Autism, Language Acquisition, Language Development, Toddlers

In brief

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.

Key facts

Study ID

NCT01339767

Run by

National Institute of Mental Health (NIMH)

People needed

77

Starts

2011-04-18

Expected to finish

2017-06-30

Last updated by the study team

2019-12-12

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• At-risk Group:
• 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)
• Typically Developing Group:
• 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
• Healthy Adult Group:
• Historical or current psychiatric, neurological, or serious medical illness
• Primary language is other than English
• Difficulty hearing (as some sounds and words will be presented during the MRI scan)
• Head injury with loss of consciousness in the last year
• Metal in the body which would make having an MRI scan unsafe, such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have.
• Discomfort in small closed spaces (have claustrophobia) so that there would be discomfort in the MRI machine.
• Inability to lie comfortably flat on the back for up to 60 minutes in the MRI scanner
• If female, and pregnant
• Inability to provide own consent

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.