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Efficacy of AMALS in Treating Language Impairment in Children

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00840060
Acronym
AMALS
Enrollment
40
Registered
2009-02-10
Start date
2009-01-31
Completion date
2010-12-31
Last updated
2012-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Language Disorder

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.

Interventions

BEHAVIORALAMALS

Addressing multiple aspects of language simultaneously

BEHAVIORALDTA

Discrete Trial Approach

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
Lamar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Language Sample AnalysisLanguage samples were obtained pre-treatment, post-treatment, and at one-month follow-up.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.
Number of Verb Structures Per UtterancePre-treatment, post-treatment, 1-month follow-upSamples were transcribed and segmented by utterance. Utterances were analyzed for novel verb structures. Structures were included if they were produced more than one time.

Countries

United States

Participant flow

Recruitment details

Children were recruited at three public school sites. From January 2009 to May 2010, 50 participants were successfully recruited. Of the 50, 40 met inclusion criteria and were randomly assigned to one of the two treatments.

Pre-assignment details

No participants were excluded from the treatment following enrollment.

Participants by arm

ArmCount
Addressing Multiple Aspects of Language Simultaneously
Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
20
Discrete Trial Approach
Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
20
Total40

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyChange in emotional/behavioral status01
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicDiscrete Trial ApproachAddressing Multiple Aspects of Language SimultaneouslyTotal
Age, Categorical
<=18 years
20 Participants20 Participants40 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age Continuous4.90 years
STANDARD_DEVIATION 0.51
4.56 years
STANDARD_DEVIATION 0.5
4.74 years
STANDARD_DEVIATION 0.53
Region of Enrollment
United States
20 participants20 participants40 participants
Sex: Female, Male
Female
6 Participants9 Participants15 Participants
Sex: Female, Male
Male
14 Participants11 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

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.

Time frame: Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.

Population: Language samples were collected for all children participating in either treatment condition.

ArmMeasureGroupValue (MEAN)Dispersion
Addressing Multiple Aspects of Language SimultaneouslyLanguage Sample AnalysisInterpretive utterances: pre-treatment17.33 Percentage of utterancesStandard Deviation 3.31
Addressing Multiple Aspects of Language SimultaneouslyLanguage Sample AnalysisInterpretive utterances: post-treatment39.35 Percentage of utterancesStandard Deviation 4.04
Addressing Multiple Aspects of Language SimultaneouslyLanguage Sample AnalysisInterpretive utterances: 1-month follow-up39.70 Percentage of utterancesStandard Deviation 4.16
Addressing Multiple Aspects of Language SimultaneouslyLanguage Sample AnalysisT-units: pre-treatment52.30 Percentage of utterancesStandard Deviation 21
Addressing Multiple Aspects of Language SimultaneouslyLanguage Sample AnalysisT-units: post-treatment80.94 Percentage of utterancesStandard Deviation 13.18
Addressing Multiple Aspects of Language SimultaneouslyLanguage Sample AnalysisT-units: one-month follow-up74.88 Percentage of utterancesStandard Deviation 16.99
Addressing Multiple Aspects of Language SimultaneouslyLanguage Sample AnalysisFrequency of copula (is/are): pre-treatment56.00 Percentage of utterancesStandard Deviation 33.24
Addressing Multiple Aspects of Language SimultaneouslyLanguage Sample AnalysisFrequency of copula (is/are): post-treatment77.05 Percentage of utterancesStandard Deviation 26.78
Addressing Multiple Aspects of Language SimultaneouslyLanguage Sample AnalysisFrequency of copula (is/are): 1-month follow-up76.94 Percentage of utterancesStandard Deviation 25.72
Addressing Multiple Aspects of Language SimultaneouslyLanguage Sample AnalysisFrequency of auxiliary (is/are): pre-treatment40.11 Percentage of utterancesStandard Deviation 38.87
Addressing Multiple Aspects of Language SimultaneouslyLanguage Sample AnalysisFrequency of auxiliary (is/are): post-treatment65.23 Percentage of utterancesStandard Deviation 23.73
Addressing Multiple Aspects of Language SimultaneouslyLanguage Sample AnalysisFrequency of auxiliary (is/are): 1-month follow-up50.23 Percentage of utterancesStandard Deviation 34.15
Discrete Trial ApproachLanguage Sample AnalysisFrequency of auxiliary (is/are): post-treatment59.12 Percentage of utterancesStandard Deviation 26.02
Discrete Trial ApproachLanguage Sample AnalysisInterpretive utterances: pre-treatment18.00 Percentage of utterancesStandard Deviation 3.22
Discrete Trial ApproachLanguage Sample AnalysisFrequency of copula (is/are): pre-treatment71.00 Percentage of utterancesStandard Deviation 33.59
Discrete Trial ApproachLanguage Sample AnalysisInterpretive utterances: post-treatment26.38 Percentage of utterancesStandard Deviation 3.92
Discrete Trial ApproachLanguage Sample AnalysisFrequency of auxiliary (is/are): pre-treatment48.87 Percentage of utterancesStandard Deviation 35.13
Discrete Trial ApproachLanguage Sample AnalysisInterpretive utterances: 1-month follow-up20.55 Percentage of utterancesStandard Deviation 4.04
Discrete Trial ApproachLanguage Sample AnalysisFrequency of copula (is/are): post-treatment76.43 Percentage of utterancesStandard Deviation 26.12
Discrete Trial ApproachLanguage Sample AnalysisT-units: pre-treatment53.77 Percentage of utterancesStandard Deviation 22.7
Discrete Trial ApproachLanguage Sample AnalysisFrequency of auxiliary (is/are): 1-month follow-up48.68 Percentage of utterancesStandard Deviation 24.51
Discrete Trial ApproachLanguage Sample AnalysisT-units: post-treatment69.78 Percentage of utterancesStandard Deviation 20.19
Discrete Trial ApproachLanguage Sample AnalysisFrequency of copula (is/are): 1-month follow-up75.81 Percentage of utterancesStandard Deviation 23.55
Discrete Trial ApproachLanguage Sample AnalysisT-units: one-month follow-up55.83 Percentage of utterancesStandard Deviation 29.48
Primary

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.

Time frame: Pre-treatment, post-treatment, 1-month follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Addressing Multiple Aspects of Language SimultaneouslyNumber of Verb Structures Per UtteranceNovel verb structures per utterance: pre-treatment3.52 Novel verb structures per utteranceStandard Deviation 2.26
Addressing Multiple Aspects of Language SimultaneouslyNumber of Verb Structures Per UtteranceNovel verb structure per utterance: post-treatment5.94 Novel verb structures per utteranceStandard Deviation 1.59
Addressing Multiple Aspects of Language SimultaneouslyNumber of Verb Structures Per UtteranceNovel verb structures per utterance: 1-month follo5.41 Novel verb structures per utteranceStandard Deviation 2.78
Discrete Trial ApproachNumber of Verb Structures Per UtteranceNovel verb structures per utterance: pre-treatment4.15 Novel verb structures per utteranceStandard Deviation 2.16
Discrete Trial ApproachNumber of Verb Structures Per UtteranceNovel verb structure per utterance: post-treatment4.61 Novel verb structures per utteranceStandard Deviation 1.78
Discrete Trial ApproachNumber of Verb Structures Per UtteranceNovel verb structures per utterance: 1-month follo4.16 Novel verb structures per utteranceStandard Deviation 2.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026