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

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

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.

Study Overview

• Status: Completed
• Conditions: Language Disorder
• Intervention / Treatment: Behavioral: AMALS; Behavioral: DTA

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Orange, Texas, United States, 77631
      • West Orange Cove Consolidated Independent School District
    • Orange, Texas, United States, 77632
      • Little-Cypress Mauriceville Consolidated School District
    • Port Arthur, Texas, United States, 77640
      • Port Arthur Independent School District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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

Collaborators and Investigators

• Sponsor: Lamar University
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Monica L Bellon-Harn, Ph.D., Lamar University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: February 9, 2009
• First Submitted That Met QC Criteria: February 9, 2009
• First Posted (ESTIMATE): February 10, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 15, 2012
• Last Update Submitted That Met QC Criteria: May 14, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Communication Disorders; Language Disorders
• Other Study ID Numbers: RDC009027A-01A2; 1R15DC009027-01A2 (NIH); NIDCD RDC009027A-01A2