Working on Rapid Language Development in Toddlers (WORLD)
June 27, 2017 updated by: Ann Kaiser, Vanderbilt University
An Efficacy Trial of Milieu Teaching Language Intervention in Children With Language Disorders
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 3 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Language delay
Exclusion Criteria:
- Hearing loss
- Language other than English as the home language
- Additional disabilities (e.g., autism, Down syndrome)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Enhanced Milieu Teaching
Parents receive 28 intervention sessions in which they learn to use language support strategies with their children. Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline. |
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.
|
|
No Intervention: Community Services
Children receive speech-language services in the community.
Children are assessed at baseline, 4 months after baseline, 10 months after baseline, and 16 months after baseline.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Language Skills at 4 Months After Baseline as Measured by the Pre-school Language Scale - 4th Edition
Time Frame: 4 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Expressive Vocabulary at 4 Months After Baseline
Time Frame: 4 months
|
Number of different words the child says during a 20-minute language sample.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
October 23, 2013
First Submitted That Met QC Criteria
October 28, 2013
First Posted (Estimate)
November 5, 2013
Study Record Updates
Last Update Posted (Actual)
January 26, 2018
Last Update Submitted That Met QC Criteria
June 27, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 090904
- R324A090181 (Other Grant/Funding Number: IES)
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