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Efficacy of AMALS in Treating Language Impairment in Children (AMALS)

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ClinicalTrials.gov Identifier: NCT00840060
Recruitment Status : Completed
First Posted : February 10, 2009
Results First Posted : May 15, 2012
Last Update Posted : May 15, 2012
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Monica L. Harn, Lamar University

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.


Condition or disease Intervention/treatment Phase
Language Disorder Behavioral: AMALS Behavioral: DTA Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: AMALS: Addressing Multiple Aspects of Language Simultaneously: A Randomized Clinical Trial
Study Start Date : January 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: AMALS
Addressing multiple aspects of language simultaneously
Behavioral: AMALS
Addressing multiple aspects of language simultaneously
Experimental: DTA
Discrete Trial Approach
Behavioral: DTA
Discrete Trial Approach



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840060


Locations
United States, Texas
West Orange Cove Consolidated Independent School District
Orange, Texas, United States, 77631
Little-Cypress Mauriceville Consolidated School District
Orange, Texas, United States, 77632
Port Arthur Independent School District
Port Arthur, Texas, United States, 77640
Sponsors and Collaborators
Lamar University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Monica L Bellon-Harn, Ph.D. Lamar University

Responsible Party: Monica L. Harn, Associate Professor, Speech and Hearing Services, Lamar University
ClinicalTrials.gov Identifier: NCT00840060     History of Changes
Other Study ID Numbers: RDC009027A-01A2
1R15DC009027-01A2 ( U.S. NIH Grant/Contract )
NIDCD RDC009027A-01A2
First Posted: February 10, 2009    Key Record Dates
Results First Posted: May 15, 2012
Last Update Posted: May 15, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms