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Sponsored by: |
National Institute on Deafness and Other Communication Disorders (NIDCD) |
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Information provided by: | National Institute on Deafness and Other Communication Disorders (NIDCD) |
ClinicalTrials.gov Identifier: | NCT00723151 |
The purpose of the study is to determine if a more intensive application of communication intervention, i.e. 5 hours per week, will result in more frequent intentional communication acts, greater lexical density, and a better verbal comprehension level than children who receive the same communication intervention only one time per week.
Condition | Intervention | Phase |
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Communication Disorders Developmental Disabilities |
Behavioral: Milieu Communication Teaching |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Effects of Intensity of Early Communication Intervention |
Estimated Enrollment: | 60 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Low Intensity: Experimental
One hour of intervention per week
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Behavioral: Milieu Communication Teaching
Communication intervention targeting intentional communication and language skills provided either one hour per week or one hour per day, five days per week
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High Intensity: Experimental
Five hours of intervention per week, one hour per day for five days per week
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Behavioral: Milieu Communication Teaching
Communication intervention targeting intentional communication and language skills provided either one hour per week or one hour per day, five days per week
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Our research team has pioneered the development of a prelinguistic communication intervention referred to as Parent Responsivity Education-Milieu Communication Teaching (PRE-MCT). This intervention is designed to establish and enhance the development of intentional communication prior to the onset of spoken language in children with language delays and disorders. In the early stages of intervention, clinicians target children's use of gestures, vocalizations, and eye contact to produce more frequent and more complex nonverbal communication acts. As the children develop, goals shift to the direct teaching of words and sentence structures.
Our preliminary research using randomized experimental designs has tested the effects of the intervention when delivered in a very small 'dose', averaging just over one hour per week for six months. This standard dose has led to significant but modest effects in the children's use of intentional communication and early language, such that it could be adopted by speech-language pathologists as part of standard care. Unfortunately, the early benefits have not always been maintained 6 and 12 months after the therapy phase ends and have not always benefitted all children.
This research is a test of the hypothesis that a more intensive application of the intervention will have dramatically more positive outcomes than the standard dosage.
Ages Eligible for Study: | 18 Months to 27 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Peggy Waggoner, M.A. | 913-588-0735 | pwaggoner@kumc.edu |
Contact: Nicole I. Thompson, B.A | 615-322-5127 | nicole.thompson@Vanderbilt.Edu |
United States, Kansas | |
University of Kansas Medical Center | Recruiting |
Kansas City, Kansas, United States, 66160 | |
Contact: Peggy Waggoner, M.A. 913-588-0737 pwaggoner@kumc.edu | |
Contact: Shelley L. Bredin-Oja, M.A. 913-588-0574 sbredin-oja@kumc.edu | |
Principal Investigator: Marc E. Fey, Ph.D. | |
United States, Tennessee | |
Vanderbilt University | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: Nicole I Thompson, B.A. 615-322-5127 nicole.thompson@Vanderbilt.Ecu | |
Contact: Elizabeth L Gardner, M.A 615-322-8276 elizabeth.gardner@Vanderbilt.Edu | |
Principal Investigator: Paul J Yoder, Ph.D. |
Principal Investigator: | Steven F. Warren, Ph.D. | University of Kansas |
Responsible Party: | University of Kansas ( Steven F. Warren, Ph. D. Vice Provost for Research and Graduate Studies ) |
Study ID Numbers: | DC007660, R01 DC007660 |
Study First Received: | July 24, 2008 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00723151 History of Changes |
Health Authority: | United States: Federal Government |
Developmental Disabilities Signs and Symptoms Mental Disorders Mental Disorders Diagnosed in Childhood |
Neurologic Manifestations Neurobehavioral Manifestations Communication Disorders |
Developmental Disabilities Signs and Symptoms Mental Disorders Nervous System Diseases |
Mental Disorders Diagnosed in Childhood Neurologic Manifestations Neurobehavioral Manifestations Communication Disorders |