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.

Study Overview

• Status: Completed
• Conditions: Developmental Disabilities; Communication Disorders
• Intervention / Treatment: Behavioral: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Parent Responsivity Education-Milieu Communication Teaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of intentional communication, lexical density (observational), and vocabulary (parent report)	Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Parental stress level	Pre-treatment and post-treatment
Parental responsivity	Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment

Collaborators and Investigators

• Sponsor: University of Kansas
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Steven F. Warren, Ph.D., University of Kansas

Publications and helpful links

General Publications

• 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.
• 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).
• 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).
• 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.
• 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).

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: July 24, 2008
• First Submitted That Met QC Criteria: July 24, 2008
• First Posted (Estimate): July 28, 2008

Study Record Updates

• Last Update Posted (Estimate): November 1, 2010
• Last Update Submitted That Met QC Criteria: October 29, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Developmental Disabilities; Communication Disorders
• Other Study ID Numbers: DC007660; R01DC007660 (U.S. NIH Grant/Contract)