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Working on Rapid Language Development in Toddlers (WORLD)

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ClinicalTrials.gov Identifier: NCT01975922
Recruitment Status : Completed
First Posted : November 5, 2013
Results First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Ann Kaiser, Vanderbilt University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Language Developmental Disorders Behavioral: Enhanced Milieu Teaching Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Efficacy Trial of Milieu Teaching Language Intervention in Children With Language Disorders
Study Start Date : September 2009
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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Arms and Interventions
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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.

 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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Expressive Vocabulary at 4 Months After Baseline [ Time Frame: 4 months ]
    Number of different words the child says during a 20-minute language sample.


Eligibility Criteria
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Ages Eligible for Study:   24 Months to 42 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Language delay

Exclusion Criteria:

  • Hearing loss
  • Language other than English as the home language
  • Additional disabilities (e.g., autism, Down syndrome)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975922


Locations
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United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Ann P Kaiser, PhD Vanderbilt University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ann Kaiser, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01975922    
Other Study ID Numbers: 090904
R324A090181 ( Other Grant/Funding Number: IES )
First Posted: November 5, 2013    Key Record Dates
Results First Posted: January 26, 2018
Last Update Posted: January 26, 2018
Last Verified: June 2017
Keywords provided by Ann Kaiser, Vanderbilt University:
language impairment
language disorder
language delay
late talkers
late talking
Additional relevant MeSH terms:
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Language Disorders
Developmental Disabilities
Neurodevelopmental Disorders
Mental Disorders
 Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases