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Working on Rapid Language Development in Toddlers (WORLD)

Primary Purpose

Language Developmental Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Milieu Teaching
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Language Developmental Disorders focused on measuring language impairment, language disorder, language delay, late talkers, late talking

Eligibility Criteria

24 Months - 42 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Language delay

Exclusion Criteria:

  • Hearing loss
  • Language other than English as the home language
  • Additional disabilities (e.g., autism, Down syndrome)

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enhanced Milieu Teaching

Community Services

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Expressive Vocabulary at 4 Months After Baseline
Number of different words the child says during a 20-minute language sample.

Full Information

First Posted
October 23, 2013
Last Updated
June 27, 2017
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT01975922
Brief Title
Working on Rapid Language Development in Toddlers
Acronym
WORLD
Official Title
An Efficacy Trial of Milieu Teaching Language Intervention in Children With Language Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Developmental Disorders
Keywords
language impairment, language disorder, language delay, late talkers, late talking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Milieu Teaching
Arm Type
Experimental
Arm Description
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.
Arm Title
Community Services
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Milieu Teaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Language Skills at 4 Months After Baseline as Measured by the Pre-school Language Scale - 4th Edition
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Expressive Vocabulary at 4 Months After Baseline
Description
Number of different words the child says during a 20-minute language sample.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
42 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Language delay Exclusion Criteria: Hearing loss Language other than English as the home language Additional disabilities (e.g., autism, Down syndrome)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann P Kaiser, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25733749
Citation
Roberts MY, Kaiser AP. Early intervention for toddlers with language delays: a randomized controlled trial. Pediatrics. 2015 Apr;135(4):686-93. doi: 10.1542/peds.2014-2134. Epub 2015 Mar 2.
Results Reference
derived

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Working on Rapid Language Development in Toddlers

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