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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
  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

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723151

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
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Steven F. Warren, Ph.D. University of Kansas
  More 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:
Communication Disorders
Developmental Disabilities
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014