Effects of Intensity of Early Communication Intervention

Phase 2

Completed

• Conditions: Developmental Disabilities; Communication Disorders
• Interventions: Behavioral: Milieu Communication Teaching

• Registration Number: NCT00723151
• Lead Sponsor: University of Kansas

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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2008-07-24
• Study First Submitted QC: 2008-07-24
• Study First Posted: 2008-07-28
• Primary Completion: 2010-09
• Status Verified: 2010-10
• Study Completion: 2010-10
• Last Update Submitted: 2010-10-29
• Last Update Posted: 2010-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Intensity	Milieu Communication Teaching	One hour of intervention per week
High Intensity	Milieu Communication Teaching	Five hours of intervention per week, one hour per day for five days per week

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Parental stress level	Pre-treatment and post-treatment
Parental responsivity	Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment

Trial Locations

Locations (2)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States