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OpenTrials
Completed

NCT Number: NCT00723151

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.

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Key information

Age range

18 month–27 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Milieu Communication Teaching

Behavioral

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

Primary outcomes

  1. 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 outcomes

  1. Parental stress level

    Time frame: Pre-treatment and post-treatment

  2. Parental responsivity

    Time frame: Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Jul 28, 2008
Registry last updated
Nov 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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