CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
AMALS +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00840060
NCT00840060Phase 2Completed

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

Lamar University·interventional·Posted Feb 10, 2009·Updated May 15, 2012

In Brief

A Phase 2 clinical trial evaluating AMALS and DTA for Language Disorder. Completed, enrolled 40 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2009
Enrollment StartJan 1, 2009
Primary CompletionDec 1, 2009
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.4 years ago

Interventions

AMALSbehavioral

Addressing multiple aspects of language simultaneously

DTAbehavioral

Discrete Trial Approach