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Effects of Intensity of Early Communication Intervention

Kansas Board of Regents logo

Kansas Board of Regents

Status and phase

Completed
Phase 2

Conditions

Developmental Disabilities
Communication Disorders

Treatments

Behavioral: Milieu Communication Teaching

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00723151
DC007660
R01DC007660 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 27 months old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Low Intensity
Experimental group
Description:
One hour of intervention per week
Treatment:
Behavioral: Milieu Communication Teaching
High Intensity
Experimental group
Description:
Five hours of intervention per week, one hour per day for five days per week
Treatment:
Behavioral: Milieu Communication Teaching

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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