Working on Rapid Language Development in Toddlers (WORLD)
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 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|
- 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).
- 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.
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01975922
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Ann P Kaiser, PhD||Vanderbilt University|