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Clinical Trials/NCT00840060
NCT00840060
Completed
Phase 2

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

Lamar University3 sites in 1 country40 target enrollmentJanuary 2009

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Language Disorder
Sponsor
Lamar University
Enrollment
40
Locations
3
Primary Endpoint
Language Sample Analysis
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
December 2010
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Monica L. Harn

Associate Professor, Speech and Hearing Services

Lamar University

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

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

Outcomes

Primary Outcomes

Language Sample Analysis

Time Frame: 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

Time Frame: 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.

Study Sites (3)

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