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Effects of Intensity of Early Communication Intervention

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00723151
First received: July 24, 2008
Last updated: October 29, 2010
Last verified: October 2010

July 24, 2008
October 29, 2010
July 2005
September 2010   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00723151 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effects of Intensity of Early Communication Intervention
Effects of Intensity of Early Communication Intervention

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Communication Disorders
  • Developmental Disabilities
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: 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
October 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Months to 27 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00723151
DC007660, R01DC007660
No
Steven F. Warren, Ph. D. Vice Provost for Research and Graduate Studies, University of Kansas
University of Kansas
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Steven F. Warren, Ph.D. University of Kansas
University of Kansas
October 2010

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