Effects of Intensity of Early Communication Intervention
| Tracking Information | |||||
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| First Received Date ICMJE | July 24, 2008 | ||||
| Last Updated Date | October 29, 2010 | ||||
| Start Date ICMJE | July 2005 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00723151 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Intensity of Early Communication Intervention | ||||
| Official Title ICMJE | Effects of Intensity of Early Communication Intervention | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 70 | ||||
| Completion Date | October 2010 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Months to 27 Months | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00723151 | ||||
| Other Study ID Numbers ICMJE | DC007660, R01DC007660 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Steven F. Warren, Ph. D. Vice Provost for Research and Graduate Studies, University of Kansas | ||||
| Study Sponsor ICMJE | University of Kansas | ||||
| Collaborators ICMJE | National Institute on Deafness and Other Communication Disorders (NIDCD) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Kansas | ||||
| Verification Date | October 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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