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NCT01339767 · ClinicalTrials.gov registry record

Study of Toddlers With Language Delay

A clinical trial of Autism and Language Development, sponsored by National Institute of Mental Health (NIMH).

Completed
Registry status
77
Enrollment target
1
Study location

NCT01339767 is a study of Autism and Language Development that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 77 participants, below the 183-participant average among 104 other Autism trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01339767, a study of Autism and Language Development, has completed, sponsored by National Institute of Mental Health (NIMH).

COMPLETED
Registry status
77 participants
Enrollment target
1
Study location

Study 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.

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2011-04-18
Est. Completion 2017-06-30

What the Registry Record Tells You About NCT01339767

The ClinicalTrials.gov registry entry for NCT01339767 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 183-participant average among 104 other Autism trials with a reported enrollment target (58% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Autism appearing as the primary indexed condition, and to 0 interventions.

NCT01339767 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01339767 about?

NCT01339767 is a clinical study titled "Study of Toddlers With Language Delay". 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 vocalizati...

What is the current status of trial NCT01339767?

This trial is currently completed. The enrollment target is 77 participants. The study started on 2011-04-18. Estimated completion is 2017-06-30.

What conditions does trial NCT01339767 study?

This clinical trial studies the following conditions: Autism, Language Development, Language Acquisition, Toddlers.

Who is sponsoring clinical trial NCT01339767?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01339767 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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