Efficacy of AMALS in Treating Language Impairment in Children (AMALS)
Primary Purpose
Language Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AMALS
DTA
Sponsored by
About this trial
This is an interventional treatment trial for Language Disorder
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
Sites / Locations
- West Orange Cove Consolidated Independent School District
- Little-Cypress Mauriceville Consolidated School District
- Port Arthur Independent School District
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AMALS
DTA
Arm Description
Addressing multiple aspects of language simultaneously
Discrete Trial Approach
Outcomes
Primary Outcome Measures
Language Sample Analysis
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00840060
First Posted
February 9, 2009
Last Updated
May 14, 2012
Sponsor
Lamar University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT00840060
Brief Title
Efficacy of AMALS in Treating Language Impairment in Children
Acronym
AMALS
Official Title
AMALS: Addressing Multiple Aspects of Language Simultaneously: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lamar University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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?
Will these gains be maintained at one-month follow up?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMALS
Arm Type
Experimental
Arm Description
Addressing multiple aspects of language simultaneously
Arm Title
DTA
Arm Type
Experimental
Arm Description
Discrete Trial Approach
Intervention Type
Behavioral
Intervention Name(s)
AMALS
Intervention Description
Addressing multiple aspects of language simultaneously
Intervention Type
Behavioral
Intervention Name(s)
DTA
Intervention Description
Discrete Trial Approach
Primary Outcome Measure Information:
Title
Language Sample Analysis
Description
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.
Time Frame
Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.
Title
Number of Verb Structures Per Utterance
Description
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.
Time Frame
Pre-treatment, post-treatment, 1-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica L Bellon-Harn, Ph.D.
Organizational Affiliation
Lamar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Orange Cove Consolidated Independent School District
City
Orange
State/Province
Texas
ZIP/Postal Code
77631
Country
United States
Facility Name
Little-Cypress Mauriceville Consolidated School District
City
Orange
State/Province
Texas
ZIP/Postal Code
77632
Country
United States
Facility Name
Port Arthur Independent School District
City
Port Arthur
State/Province
Texas
ZIP/Postal Code
77640
Country
United States
12. IPD Sharing Statement
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Efficacy of AMALS in Treating Language Impairment in Children
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