Building Complex Language
Primary Purpose
Language Development Disorders, Learning Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Complex sentence treatment protocol
Sponsored by
About this trial
This is an interventional treatment trial for Language Development Disorders focused on measuring language development disorders, learning disorders, sentences, syntax, school-age, language
Eligibility Criteria
Inclusion Criteria:
- Disability: documented language or learning disorder
- Nonverbal IQ within 1 standard deviation of mean for age
- Oral language score 1 or more standard deviations below mean for age
- Problem areas: difficulty with language in any of the following areas - reading comprehension, writing, following verbal instructions, verbal expression
Exclusion Criteria:
- hearing impairment
- autism spectrum disorder
- developmental delay
- genetic syndrome
- brain injury
- cerebral palsy
- seizure disorder
Sites / Locations
- Rush University Medical Center
- Governors State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1 session per week
2 sessions per week
Arm Description
Outcomes
Primary Outcome Measures
Changes in Scores on Norm-Referenced and Criterion-Referenced Language Tests
A battery of language comprehension and production measures given pre-treatment will be administered again following treatment. The measures include broad norm-referenced oral and written language tests and a specific criterion-referenced measure of complex sentence production.
Secondary Outcome Measures
Full Information
NCT ID
NCT01337232
First Posted
April 13, 2011
Last Updated
November 21, 2013
Sponsor
Governors State University
Collaborators
Rush University
1. Study Identification
Unique Protocol Identification Number
NCT01337232
Brief Title
Building Complex Language
Official Title
Building Complex Language: Effect of Treatment and Dosage
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Governors State University
Collaborators
Rush University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to examine how much therapy is needed in order to make significant gains in knowledge and use of complex sentences. Students will be randomly placed in individual treatment sessions that take place either once or twice per week for nine weeks. All will receive the same type of treatment, which consists of a focused series of oral and written language activities. While it is anticipated that students in both groups will benefit from treatment, we hypothesize that the twice-weekly session frequency will have a significantly greater impact on level of performance and maintenance of skills after treatment.
Detailed Description
The objective of this project is to examine outcomes of a treatment intervention designed to increase functional use of complex (multi-clausal) sentences in school-age students with primary language impairments that impact literacy and academic achievement. The treatment protocol includes: (1) three types of complex sentences (adverbial, relative, object complement), (2) encounters with complex sentences in real texts and across all modalities (speaking, listening, reading, writing, and (3) activities that engage metalinguistic understanding of complex sentences. Specific objectives are to (1) document treatment effect in terms of size and scope of impact in decontextualized as well as naturalistic language contexts, (2) document the effect of treatment intensity (dosage), (3) explore effects of sentence complexity subtype and treatment outcomes, and (4) explore relationships between treatment outcomes and participant variables (pre-treatment knowledge of complex sentences, verbal working memory, and non-verbal cognition).
The study will utilize two designs. Approximately 10 participants per year will complete the treatment, randomly assigned to one of two treatment levels. As each participant finishes, efficacy and effect size will be measured using a multiple-baseline single-subject design. Once all 30 participants have completed the treatment, effect size and the impact of dosage (treatment intensity) will be evaluated using a pretest-posttest group design, and correlations between participant characteristics and individual patterns of performance will be carefully described and analyzed.
This study targets school-age students with a Speech-Language Impairment and/or a Specific Learning Disability between the ages of 10 and 14 who are receiving services from a Speech-Language Pathologist (SLP) for one or more higher-level language behaviors. It is expected that participants will demonstrate higher levels of fluency with complex sentences compared with pretreatment baseline levels and that treatment effects will be reflected in several modalities and in naturalistic language contexts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Development Disorders, Learning Disorders
Keywords
language development disorders, learning disorders, sentences, syntax, school-age, language
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 session per week
Arm Type
Active Comparator
Arm Title
2 sessions per week
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Complex sentence treatment protocol
Intervention Description
Treatment: listening, speaking, reading, and writing activities that teach three types of complex sentences. Individual sessions are 40 minutes in length, delivered by or under the supervision of a certified, trained speech-language pathologist.
Primary Outcome Measure Information:
Title
Changes in Scores on Norm-Referenced and Criterion-Referenced Language Tests
Description
A battery of language comprehension and production measures given pre-treatment will be administered again following treatment. The measures include broad norm-referenced oral and written language tests and a specific criterion-referenced measure of complex sentence production.
Time Frame
within one month post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Disability: documented language or learning disorder
Nonverbal IQ within 1 standard deviation of mean for age
Oral language score 1 or more standard deviations below mean for age
Problem areas: difficulty with language in any of the following areas - reading comprehension, writing, following verbal instructions, verbal expression
Exclusion Criteria:
hearing impairment
autism spectrum disorder
developmental delay
genetic syndrome
brain injury
cerebral palsy
seizure disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine H Balthazar, PhD
Organizational Affiliation
Governors State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheryl M Scott, PhD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Governors State University
City
University Park
State/Province
Illinois
ZIP/Postal Code
60484
Country
United States
12. IPD Sharing Statement
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Building Complex Language
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