Effects of Intensity of Early Communication Intervention

Developmental Disabilities Clinical Trial

Official title:

Effects of Intensity of Early Communication Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723151
• Other study ID #: DC007660
• Secondary ID: R01DC007660
• Status: Completed
• Phase: Phase 2
• First received: July 24, 2008
• Last updated: October 29, 2010
• Start date: July 2005
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 27 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communication Disorders
• Developmental Disabilities

Intervention

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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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). — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Parental stress level		Pre-treatment and post-treatment	No
Secondary	Parental responsivity		Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment	No

External Links

•   Language Intervention Lab