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临床试验/NCT00840060
NCT00840060已完成2 期

AMALS: Addressing Multiple Aspects of Language Simultaneously: A Randomized Clinical Trial

Lamar University6 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
40
试验地点
6
主要终点
Language Sample Analysis

研究概览

简要总结

The goal of this proposal is to examine the efficacy of a manualized treatment intervention, AMALS: Addressing Multiple Aspects of Language Simultaneously, which is designed to remediate semantic, morphological, and syntactic aspects of language in preschool children with language impairment. This study will target preschool children with language impairment living in a region characterized by nonmainstream dialects.

Questions driving this work are:

  1. Will children participating in the AMALS treatment exhibit greater semantic, morphological, and syntactic complexity on multiple outcome measures at the completion of the intervention compared to a Discrete Trial Approach (DTA) group?
  2. Will these gains be maintained at one-month follow up?
  3. What is the impact of dialect on dependent variables, specifically morphosyntactic abilities?

To answer these questions a randomized clinical trial will be conducted comparing AMALS, an integrated approach to treatment, with DTA, an additive approach to therapy. In this study rather than restrict the ethnic and cultural backgrounds of this population, children's use of dialect will be uniquely identified and examined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Demonstrate sufficient intelligibility as determined by a score of 85% on percent consonant correct (PCC) measures;
  • Demonstrate sufficient phonological ability to use grammatical morphemes as determined by use of word-final /s, z, t, d/ on sound- in-word subtest from the Goldman-Fristoe Test of Articulation-2 (GFTA; Goldman & Fristoe, 2000)
  • Nonverbal IQ above 70 as scored on the Columbia Mental Maturity Scale (CMMS; Burgemeister, Blum, & Lorge, 1972);
  • Below 1SD on the Diagnostic Evaluation of Language Variation: Norm-referenced Test (DELV; Seymour, Roeper & de Villiers, 2005);
  • Below 1.39SD on the Structured Photographic Expressive Language Test-Preschool (SPELT-P; Werner & Kresheck, 1983);
  • Documentation from teachers and/or parents of impressions of language status in comparison with peers;
  • More than one standard deviation below the mean on both levels 3 and 4 of the Preschool Language Assessment Instrument (PLAI; Blank, Rose, & Berlin, 1978).

排除标准

  • English as the primary language
  • No oral-motor impairment
  • No hearing impairment
  • No co-morbid psychiatric or neurological impairments

结局指标

主要结局

Language Sample Analysis

时间窗: Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.

Samples were transcribed and segmented by utterance. Each was coded categorically. Reported measures include percentage of utterances at the interpretive/inferential label, percentage of utterances with one or more t-unit (i.e., noun phrase + verb phrase), percentage of utterances that required copula (is/are) or auxiliary (is/are) that were produced.

Number of Verb Structures Per Utterance

时间窗: Pre-treatment, post-treatment, 1-month follow-up

Samples were transcribed and segmented by utterance. Utterances were analyzed for novel verb structures. Structures were included if they were produced more than one time.

次要结局

未报告次要终点

研究者

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

Monica L. Harn

Associate Professor, Speech and Hearing Services

Lamar University

研究点 (6)

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