Effects of Intensity of Early Communication Intervention

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ClinicalTrials.gov Identifier: NCT00723151

Recruitment Status : Completed

First Posted : July 28, 2008

Last Update Posted : November 1, 2010

Sponsor:

Collaborator:

National Institute on Deafness and Other Communication Disorders (NIDCD)

Information provided by:

University of Kansas Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Communication Disorders Developmental Disabilities	Behavioral: Milieu Communication Teaching	Phase 2

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 Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	70 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Effects of Intensity of Early Communication Intervention
Study Start Date :	July 2005
Actual Primary Completion Date :	September 2010
Actual Study Completion Date :	October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Speech and Communication Disorders

U.S. FDA Resources

Arms and Interventions

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 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

Outcome Measures

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 ]

Secondary Outcome Measures :

Parental stress level [ Time Frame: Pre-treatment and post-treatment ]
Parental responsivity [ Time Frame: Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment ]

Eligibility Criteria

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Ages Eligible for Study:	18 Months to 27 Months (Child)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators


Principal Investigator:	Steven F. Warren, Ph.D.	University of Kansas

More Information

Additional Information:

Language Intervention Lab This link exits the ClinicalTrials.gov site

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.

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.

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.

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. 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).


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 ( U.S. NIH Grant/Contract )
First Posted:	July 28, 2008 Key Record Dates
Last Update Posted:	November 1, 2010
Last Verified:	October 2010

Additional relevant MeSH terms:


Developmental Disabilities Communication Disorders Neurodevelopmental Disorders Mental Disorders	Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms

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