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临床试验/NCT01975922
NCT01975922已完成不适用

An Efficacy Trial of Milieu Teaching Language Intervention in Children With Language Disorders

Vanderbilt University2 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2009年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
2
主要终点
Language Skills at 4 Months After Baseline as Measured by the Pre-school Language Scale - 4th Edition

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
24 Months 至 42 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Language delay

排除标准

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

研究组 & 干预措施

Enhanced Milieu Teaching

Experimental

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.

干预措施: Enhanced Milieu Teaching (Behavioral)

Community Services

No Intervention

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.

结局指标

主要结局

Language Skills at 4 Months After Baseline as Measured by the Pre-school Language Scale - 4th Edition

时间窗: 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.

次要结局

  • Expressive Vocabulary at 4 Months After Baseline(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ann Kaiser

Professor

Vanderbilt University

研究点 (2)

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