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Effects of Intensity of Early Communication Intervention

Effects of Intensity of Early Communication Intervention

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00723151
Enrollment
70
Registered
2008-07-28
Start date
2005-07-31
Completion date
2010-10-31
Last updated
2010-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Communication Disorders, Developmental Disabilities

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.

Interventions

BEHAVIORALMilieu 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

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
University of Kansas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Months to 27 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Parental stress levelPre-treatment and post-treatment
Parental responsivityPre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026