Skip to main content
Clinical Trials/NCT00723151
NCT00723151
Completed
Phase 2

Effects of Intensity of Early Communication Intervention

University of Kansas2 sites in 1 country70 target enrollmentJuly 2005

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Communication Disorders
Sponsor
University of Kansas
Enrollment
70
Locations
2
Primary Endpoint
Rate of intentional communication, lexical density (observational), and vocabulary (parent report)
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2005
End Date
October 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Parental stress level(Pre-treatment and post-treatment)
  • Parental responsivity(Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment)

Study Sites (2)

Loading locations...

Similar Trials