Efficacy of AMALS in Treating Language Impairment in Children

NCT ID: NCT00840060

Last Updated: 2012-05-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Language Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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AMALS

Addressing multiple aspects of language simultaneously

Group Type EXPERIMENTAL

AMALS

Intervention Type BEHAVIORAL

Addressing multiple aspects of language simultaneously

DTA

Discrete Trial Approach

Group Type EXPERIMENTAL

DTA

Intervention Type BEHAVIORAL

Discrete Trial Approach

Interventions

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AMALS

Addressing multiple aspects of language simultaneously

Intervention Type BEHAVIORAL

DTA

Discrete Trial Approach

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Demonstrate sufficient intelligibility as determined by a score of 85% on percent consonant correct (PCC) measures;
2. 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)
3. Nonverbal IQ above 70 as scored on the Columbia Mental Maturity Scale (CMMS; Burgemeister, Blum, \& Lorge, 1972);
4. Below 1SD on the Diagnostic Evaluation of Language Variation: Norm-referenced Test (DELV; Seymour, Roeper \& de Villiers, 2005);
5. Below 1.39SD on the Structured Photographic Expressive Language Test-Preschool (SPELT-P; Werner \& Kresheck, 1983);
6. Documentation from teachers and/or parents of impressions of language status in comparison with peers;
7. 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

1. English as the primary language
2. No oral-motor impairment
3. No hearing impairment
4. No co-morbid psychiatric or neurological impairments
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Lamar University

OTHER

Sponsor Role lead

Responsible Party

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Monica L. Harn

Associate Professor, Speech and Hearing Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Monica L Bellon-Harn, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Lamar University

Locations

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West Orange Cove Consolidated Independent School District

Orange, Texas, United States

Site Status

Little-Cypress Mauriceville Consolidated School District

Orange, Texas, United States

Site Status

Port Arthur Independent School District

Port Arthur, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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1R15DC009027-01A2

Identifier Type: NIH

Identifier Source: secondary_id

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NIDCD RDC009027A-01A2

Identifier Type: -

Identifier Source: secondary_id

RDC009027A-01A2

Identifier Type: -

Identifier Source: org_study_id

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