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Completed

NCT Number: NCT00840060

Efficacy of AMALS in Treating Language Impairment in Children

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.

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Key information

Conditions

Language Disorder Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Little-Cypress Mauriceville Consolidated School District, Orange, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMALS

Behavioral

Addressing multiple aspects of language simultaneously

DTA

Behavioral

Discrete Trial Approach

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Lamar University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

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

Acronym: AMALS

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Feb 10, 2009
Registry last updated
May 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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