Effects of Intensity of Early Communication Intervention
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Purpose
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 |
|---|---|---|
|
Communication Disorders Developmental Disabilities |
Behavioral: Milieu Communication Teaching |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of Intensity of Early Communication Intervention |
- 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 ]
- 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 ]
| Estimated Enrollment: | 70 |
| Study Start Date: | July 2005 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Months to 27 Months |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 |
More Information
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 |
| Study First Received: | July 24, 2008 |
| Last Updated: | October 29, 2010 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Developmental Disabilities Communication Disorders Mental Disorders Diagnosed in Childhood Mental Disorders |
Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013