Efficacy of AMALS in Treating Language Impairment in Children

NCT00840060 | Completed Phase 2 Results DMC

• 3 other identifiers: RDC009027A-01A21R15DC009027-01A2NIDCD RDC009027A-01A2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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. 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. 2.Will these gains be maintained at one-month follow up?
3. 3.What is the impact of dialect on dependent variables, specifically morphosyntactic abilities?

Conditions

Language Disorder

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

AMALS

EXPERIMENTAL

Addressing multiple aspects of language simultaneously

Behavioral: AMALS

DTA

EXPERIMENTAL

Discrete Trial Approach

Behavioral: DTA

Interventions

AMALS BEHAVIORAL

Addressing multiple aspects of language simultaneously

AMALS

DTA BEHAVIORAL

Discrete Trial Approach

DTA

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• English as the primary language
• No oral-motor impairment
• No hearing impairment
• No co-morbid psychiatric or neurological impairments

Sponsors & Collaborators

• Lamar University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (3)

West Orange Cove Consolidated Independent School District

Orange, Texas, 77631, United States

Location

Little-Cypress Mauriceville Consolidated School District

Orange, Texas, 77632, United States

Location

Port Arthur Independent School District

Port Arthur, Texas, 77640, United States

Location

MeSH Terms

Conditions

Language Disorders

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Problems with stratification according to dialect prior to randomization lead to difficulty interpreting results related to dialect

Results Point of Contact

• Title: Monica Harn
• Organization: Lamar University

monica.harn@lamar.edu

409-880-8174

Study Officials

• Monica L Bellon-Harn, Ph.D.

  Lamar University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Speech and Hearing Services

Study Record Dates

• First Submitted: February 9, 2009
• First Posted: February 10, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: May 15, 2012
• Results First Posted: May 15, 2012

Record last verified: 2012-05

Locations

US (3)