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Effects of Intensity of Early Communication Intervention

Primary Purpose

Communication Disorders, Developmental Disabilities

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Milieu Communication Teaching
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Communication Disorders

Eligibility Criteria

18 Months - 27 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kansas Medical Center
  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Intensity

High Intensity

Arm Description

One hour of intervention per week

Five hours of intervention per week, one hour per day for five days per week

Outcomes

Primary Outcome Measures

Rate of intentional communication, lexical density (observational), and vocabulary (parent report)

Secondary Outcome Measures

Parental stress level
Parental responsivity

Full Information

First Posted
July 24, 2008
Last Updated
October 29, 2010
Sponsor
University of Kansas
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT00723151
Brief Title
Effects of Intensity of Early Communication Intervention
Official Title
Effects of Intensity of Early Communication Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Kansas
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Communication Disorders, Developmental Disabilities

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Intensity
Arm Type
Experimental
Arm Description
One hour of intervention per week
Arm Title
High Intensity
Arm Type
Experimental
Arm Description
Five hours of intervention per week, one hour per day for five days per week
Intervention Type
Behavioral
Intervention Name(s)
Milieu Communication Teaching
Other Intervention Name(s)
Parent Responsivity Education-Milieu Communication Teaching
Intervention Description
Communication intervention targeting intentional communication and language skills provided either one hour per week or one hour per day, five days per week
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Parental stress level
Time Frame
Pre-treatment and post-treatment
Title
Parental responsivity
Time Frame
Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
27 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven F. Warren, Ph.D.
Organizational Affiliation
University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9771641
Citation
Yoder PJ, Warren SF. Maternal responsivity predicts the prelinguistic communication intervention that facilitates generalized intentional communication. J Speech Lang Hear Res. 1998 Oct;41(5):1207-19. doi: 10.1044/jslhr.4105.1207.
Results Reference
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PubMed Identifier
11218105
Citation
Yoder PJ, Warren SF. Relative treatment effects of two prelinguistic communication interventions on language development in toddlers with developmental delays vary by maternal characteristics. J Speech Lang Hear Res. 2001 Feb;44(1):224-37. doi: 10.1044/1092-4388(2001/019).
Results Reference
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PubMed Identifier
12546485
Citation
Yoder PJ, Warren SF. Effects of prelinguistic milieu teaching and parent responsivity education on dyads involving children with intellectual disabilities. J Speech Lang Hear Res. 2002 Dec;45(6):1158-74. doi: 10.1044/1092-4388(2002/094).
Results Reference
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PubMed Identifier
16787894
Citation
Fey ME, Warren SF, Brady N, Finestack LH, Bredin-Oja SL, Fairchild M, Sokol S, Yoder PJ. Early effects of responsivity education/prelinguistic milieu teaching for children with developmental delays and their parents. J Speech Lang Hear Res. 2006 Jun;49(3):526-47. doi: 10.1044/1092-4388(2006/039). Erratum In: J Speech Lang Hear Res. 2007 Apr;50(2): 549.
Results Reference
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PubMed Identifier
18367689
Citation
Warren SF, Fey ME, Finestack LH, Brady NC, Bredin-Oja SL, Fleming KK. A randomized trial of longitudinal effects of low-intensity responsivity education/prelinguistic milieu teaching. J Speech Lang Hear Res. 2008 Apr;51(2):451-70. doi: 10.1044/1092-4388(2008/033).
Results Reference
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Effects of Intensity of Early Communication Intervention

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