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| Brief Title † | Effects of Intensity of Early Communication Intervention | ||||||||
| Official Title † | 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 Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | 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 ] | ||||||||
| Secondary Outcome Measure † | Parental stress level [ Time Frame: Pre-treatment and post-treatment ] [ Designated as safety issue: No ] Parental responsivity [ Time Frame: Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment ] [ Designated as safety issue: No ] |
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| Condition † | Communication Disorders Developmental Disabilities |
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| Intervention † | Behavioral: Milieu Communication Teaching | ||||||||
| MEDLINE PMIDs | 9771641, 11218105, 12546485, 16787894, 18367689 | ||||||||
| Links | Language Intervention Lab  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 60 | ||||||||
| Start Date † | July 2005 | ||||||||
| Completion Date | July 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Months to 27 Months | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00723151 | ||||||||
| Organization ID | DC007660 | ||||||||
| Secondary IDs †† | R01 DC007660 | ||||||||
| Study Sponsor † | National Institute on Deafness and Other Communication Disorders (NIDCD) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute on Deafness and Other Communication Disorders (NIDCD) | ||||||||
| Verification Date | July 2008 | ||||||||
| First Received Date † | July 24, 2008 | ||||||||
| Last Updated Date | July 24, 2008 | ||||||||
