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| ID | Type | Description | Link |
|---|---|---|---|
| 1R15DC009027-01A2 | U.S. NIH Grant/Contract | View source | |
| NIDCD RDC009027A-01A2 |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMALS | Experimental | Addressing multiple aspects of language simultaneously |
|
| DTA | Experimental | Discrete Trial Approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMALS | Behavioral | Addressing multiple aspects of language simultaneously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up. |
| 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. | Pre-treatment, post-treatment, 1-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monica L Bellon-Harn, Ph.D. | Lamar University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Orange Cove Consolidated Independent School District | Orange | Texas | 77631 | United States | ||
| Little-Cypress Mauriceville Consolidated School District |
No participants were excluded from the treatment following enrollment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Discrete Trial Approach |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Language samples were collected for all children participating in either treatment condition. | Posted | Mean | Standard Deviation | Percentage of utterances | Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Problems with stratification according to dialect prior to randomization lead to difficulty interpreting results related to dialect
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Monica Harn | Lamar University | 409-880-8174 | monica.harn@lamar.edu |
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| ID | Term |
|---|---|
| D007806 | Language Disorders |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| DTA |
| Behavioral |
Discrete Trial Approach |
|
| Orange |
| Texas |
| 77632 |
| United States |
| Port Arthur Independent School District | Port Arthur | Texas | 77640 | United States |
Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
|
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| 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. | Posted | Mean | Standard Deviation | Novel verb structures per utterance | Pre-treatment, post-treatment, 1-month follow-up |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 20 | 0 | 20 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Novel verb structures per utterance: 1-month follo |
|