Working on Rapid Language Development in Toddlers

Language Developmental Disorders Clinical Trial

— WORLD  

Official title:

An Efficacy Trial of Milieu Teaching Language Intervention in Children With Language Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975922
• Other study ID #: 090904
• Secondary ID: R324A090181
• Status: Completed
• Phase: N/A
• First received: October 23, 2013
• Last updated: June 27, 2017
• Start date: September 2009
• Est. completion date: December 2015

Study information

• Verified date: June 2017
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the study is to examine the effects of teaching parents to use language support strategies on language skills in toddlers with language delays. We hypothesize that children whose parents who learn to use language support strategies at home will have greater language skills than those children whose parents do not learn the strategies.

Description:

The goal of the proposed project is to conduct an efficacy trial to determine whether Enhanced Milieu Teaching (EMT) significantly improves language deficits in young children at high risk for persistent language delays. The target population is children ages 24 -36 months who exhibit significant co-occurring delays in productive and receptive language skills, who have cognitive skills within the range of normal development, and who do not have other identified disabilities. An empirically based and manualized language intervention, Enhanced Milieu Teaching (EMT), implemented by therapists and parents will be compared to community based "business as usual" services in a randomized experiment enrolling 120 children and their parents. Children assigned to the EMT group will receive 24, 1-hour sessions of direct intervention at home that will include teaching their parents to implement EMT procedures across activities. Children will be assessed at 4 time points (before and after intervention, at 6 months and 12 months post-intervention) allowing the description and comparison of individual language growth trajectories over a period of 18 months. In addition, we will examine the relation between language growth and emergent problems in behavior and social skill development to determine whether early language intervention can prevent these difficulties frequently associated with early language delays. Results from this study will determine the efficacy of parent-plus-therapist implemented EMT with a new population of children, provide evidence about the potential for preventing persistent language delays and secondary social effects of early language delays, and expand developmental theory linking persistent language delays to specific risk factors and behavioral outcomes. The results of this study will have specific policy implications related to early identification and the inclusion of young children with language delays as a target population for early intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Months to 42 Months

Eligibility

Inclusion Criteria:

• Language delay

Exclusion Criteria:

• Hearing loss

• Language other than English as the home language

• Additional disabilities (e.g., autism, Down syndrome)

Related Conditions & MeSH terms

• Developmental Disabilities
• Language Developmental Disorders
• Language Disorders

Intervention

Behavioral:
• Enhanced Milieu Teaching
Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Language Skills at 4 Months After Baseline as Measured by the Pre-school Language Scale - 4th Edition	Pre-school Language Scale - 4th Edition (a norm-referenced measure of receptive and expressive language) This scale measures the child's expressive and receptive language by going through a standard protocol of items, beginning based on the child's age, requiring a Basal of 3 consecutive correct responses and a Ceiling of 6 consecutive incorrect responses.; A higher score is considered better. A standard score of 100 is considered average for the child's age with scores ranging from 50-150.	4 months
Secondary	Expressive Vocabulary at 4 Months After Baseline	Number of different words the child says during a 20-minute language sample.	4 months