Effects of Intensity of Early Communication Intervention
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ClinicalTrials.gov Identifier: NCT00723151 |
Recruitment Status
:
Completed
First Posted
: July 28, 2008
Last Update Posted
: November 1, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Communication Disorders Developmental Disabilities | Behavioral: Milieu Communication Teaching | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects of Intensity of Early Communication Intervention |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | October 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Low Intensity
One hour of intervention per week
|
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
Other Name: Parent Responsivity Education-Milieu Communication Teaching
|
Experimental: High Intensity
Five hours of intervention per week, one hour per day for five days per week
|
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
Other Name: Parent Responsivity Education-Milieu Communication Teaching
|
- Rate of intentional communication, lexical density (observational), and vocabulary (parent report) [ Time Frame: Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment ]
- Parental stress level [ Time Frame: Pre-treatment and post-treatment ]
- Parental responsivity [ Time Frame: Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment ]

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Ages Eligible for Study: | 18 Months to 27 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- must produce at least one intentional communication act during administration of the Communication and Symbolic Behavior Scale
- a minimum raw score of 34 or a composite score not greater than 75 on the cognitive subtest of the Bayley Scales of Infant Development
Exclusion Criteria:
- spontaneous production of more than 20 words
- failure of a screening test for Autism
- English is not the primary language spoken in the home
- corrected hearing or corrected vision is not within normal limits

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723151
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37203 |
Principal Investigator: | Steven F. Warren, Ph.D. | University of Kansas |
Additional Information:
Publications:
Responsible Party: | Steven F. Warren, Ph. D. Vice Provost for Research and Graduate Studies, University of Kansas |
ClinicalTrials.gov Identifier: | NCT00723151 History of Changes |
Other Study ID Numbers: |
DC007660 R01DC007660 ( U.S. NIH Grant/Contract ) |
First Posted: | July 28, 2008 Key Record Dates |
Last Update Posted: | November 1, 2010 |
Last Verified: | October 2010 |
Additional relevant MeSH terms:
Developmental Disabilities Communication Disorders Neurodevelopmental Disorders Mental Disorders |
Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms |