Effects of Intensity of Early Communication Intervention

Sponsor
University of Kansas (Other)
Overall Status
Completed
CT.gov ID
NCT00723151
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
70
2
2
63
35
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Milieu Communication Teaching
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Jul 1, 2005
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Oct 1, 2010

Arms and Interventions

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 Names:
  • 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 Names:
  • Parent Responsivity Education-Milieu Communication Teaching
  • Outcome Measures

    Primary Outcome Measures

    1. Rate of intentional communication, lexical density (observational), and vocabulary (parent report) [Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment]

    Secondary Outcome Measures

    1. Parental stress level [Pre-treatment and post-treatment]

    2. Parental responsivity [Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Months to 27 Months
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kansas Medical Center Kansas City Kansas United States 66160
    2 Vanderbilt University Nashville Tennessee United States 37203

    Sponsors and Collaborators

    • University of Kansas
    • National Institute on Deafness and Other Communication Disorders (NIDCD)

    Investigators

    • Principal Investigator: Steven F. Warren, Ph.D., University of Kansas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00723151
    Other Study ID Numbers:
    • DC007660
    • R01DC007660
    First Posted:
    Jul 28, 2008
    Last Update Posted:
    Nov 1, 2010
    Last Verified:
    Oct 1, 2010
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 1, 2010