Phase 2
N=40
Efficacy of AMALS in Treating Language Impairment in Children
Language Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00840060 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Language Sample Analysis — 17.33; 18.00; 39.35; 26.38 Percentage of utterances
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AMALS (Behavioral); DTA (Behavioral)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Lamar University
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Language Sample Analysis |
17.33; 18.00; 39.35; 26.38; 39.70; 20.55 | — |
| PRIMARY Number of Verb Structures Per Utterance |
3.52; 4.15; 5.94; 4.61; 5.41; 4.16 | — |
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
- 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).
Exclusion Criteria
- English as the primary language
- No oral-motor impairment
- No hearing impairment
- No co-morbid psychiatric or neurological impairments
Data sourced from ClinicalTrials.gov (NCT00840060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.