Trial record 11 of 198 for:    "Language Disorders"

Efficacy of AMALS in Treating Language Impairment in Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Monica L. Harn, Lamar University
ClinicalTrials.gov Identifier:
NCT00840060
First received: February 9, 2009
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Language Disorder
Behavioral: AMALS
Behavioral: DTA
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: AMALS: Addressing Multiple Aspects of Language Simultaneously: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Lamar University:

Primary Outcome Measures:
  • Language Sample Analysis [ Time Frame: Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840060

Locations
United States, Texas
Little-Cypress Mauriceville Consolidated School District
Orange, Texas, United States, 77632
West Orange Cove Consolidated Independent School District
Orange, Texas, United States, 77631
Port Arthur Independent School District
Port Arthur, Texas, United States, 77640
Sponsors and Collaborators
Lamar University
Investigators
Principal Investigator: Monica L Bellon-Harn, Ph.D. Lamar University
  More Information

No publications provided

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, NIDCD RDC009027A-01A2
Study First Received: February 9, 2009
Results First Received: April 13, 2012
Last Updated: May 14, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 24, 2014