Working on Rapid Language Development in Toddlers (WORLD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Ann Kaiser, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01975922
First received: October 23, 2013
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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 Intervention
Language Developmental Disorders
Behavioral: Enhanced Milieu Teaching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Efficacy Trial of Milieu Teaching Language Intervention in Children With Language Disorders

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Change from Baseline in Language Skills at 4 months. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Preschool Language Scale-4th Edition (a norm-referenced measure of receptive and expressive language).


Secondary Outcome Measures:
  • Change from baseline in expressive vocabulary at 4 months. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Number of words the child says and average sentence length during a 20-minute language sample.


Estimated Enrollment: 120
Study Start Date: September 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: KidTalk
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.

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.

  Eligibility

Ages Eligible for Study:   24 Months to 42 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975922

Contacts
Contact: Megan Y Roberts, PhD, CCC-SLP 315-481-9605 meganyroberts@gmail.com

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Megan Y Roberts, PhD, CCC-SLP       meganyroberts@gmail.com   
Principal Investigator: Ann P Kaiser, PhD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Ann P Kaiser, PhD Vanderbilt University
  More Information

No publications provided

Responsible Party: Ann Kaiser, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01975922     History of Changes
Other Study ID Numbers: 090904, R324A090181
Study First Received: October 23, 2013
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
language impairment
language disorder
language delay
late talkers
late talking

Additional relevant MeSH terms:
Developmental Disabilities
Language Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014