Clinical trial NCT00840060: Efficacy of AMALS in Treating Language Impairment in Children
Official title: AMALS: Addressing Multiple Aspects of Language Simultaneously: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Language Disorder
Lead sponsor: Lamar University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2009-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Language Sample Analysis
timeFrame: Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.
measure: Number of Verb Structures Per Utterance
timeFrame: Pre-treatment, post-treatment, 1-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: West Orange Cove Consolidated Independent School District
state: Texas
city: Orange
country: United States
facility: Little-Cypress Mauriceville Consolidated School District
state: Texas
city: Port Arthur
country: United States
facility: Port Arthur Independent School District
state: Texas
Study officials:
affiliation: Lamar University
name: Monica L Bellon-Harn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: