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Efficacy of AMALS in Treating Language Impairment in Children

L

Lamar University

Status and phase

Completed
Phase 2

Conditions

Language Disorder

Treatments

Behavioral: AMALS
Behavioral: DTA

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00840060
RDC009027A-01A2
NIDCD RDC009027A-01A2
1R15DC009027-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

4 to 6 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

AMALS
Experimental group
Description:
Addressing multiple aspects of language simultaneously
Treatment:
Behavioral: AMALS
DTA
Experimental group
Description:
Discrete Trial Approach
Treatment:
Behavioral: DTA

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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