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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
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:
University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE July 24, 2008
First Posted Date  ICMJE July 28, 2008
Last Update Posted Date November 1, 2010
Study Start Date  ICMJE July 2005
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2008)
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 ]
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
 (submitted: July 24, 2008)
  • 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 ]
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.
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 Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Communication Disorders
  • Developmental Disabilities
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
Study Arms
  • Experimental: Low Intensity
    One hour of intervention per week
    Intervention: Behavioral: Milieu Communication Teaching
  • Experimental: High Intensity
    Five hours of intervention per week, one hour per day for five days per week
    Intervention: Behavioral: Milieu Communication Teaching
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 13, 2009)
70
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2008)
60
Actual Study Completion Date October 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Months to 27 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00723151
Other Study ID Numbers  ICMJE DC007660
R01DC007660 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
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
Principal Investigator: Steven F. Warren, Ph.D. University of Kansas
PRS Account University of Kansas Medical Center
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP