Efficacy of AMALS in Treating Language Impairment in Children

Language Disorder Clinical Trial

— AMALS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840060
• Other study ID #: RDC009027A-01A2
• Secondary ID: 1R15DC009027-01A
• Status: Completed
• Phase: Phase 2
• First received: February 9, 2009
• Last updated: May 14, 2012
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: May 2012
• Source: Lamar University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 6 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Language Disorder
• Language Disorders

Intervention

Behavioral:
• AMALS
Addressing multiple aspects of language simultaneously
• DTA
Discrete Trial Approach

Locations

Country	Name	City	State
United States	Little-Cypress Mauriceville Consolidated School District	Orange	Texas
United States	West Orange Cove Consolidated Independent School District	Orange	Texas
United States	Port Arthur Independent School District	Port Arthur	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Lamar University	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.	No
Primary	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.	Pre-treatment, post-treatment, 1-month follow-up	No