Building Complex Language
1 other identifier
interventional
31
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2011
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 13, 2011
CompletedFirst Posted
Study publicly available on registry
April 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedNovember 25, 2013
November 1, 2013
2.4 years
April 13, 2011
November 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
within one month post treatment
Study Arms (2)
1 session per week
ACTIVE COMPARATOR2 sessions per week
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- hearing impairment
- autism spectrum disorder
- developmental delay
- genetic syndrome
- brain injury
- cerebral palsy
- seizure disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Governors State Universitylead
- Rush Universitycollaborator
Study Sites (2)
Rush University Medical Center
Chicago, Illinois, 60612, United States
Governors State University
University Park, Illinois, 60484, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine H Balthazar, PhD
Governors State University
- PRINCIPAL INVESTIGATOR
Cheryl M Scott, PhD
Rush University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair, Department of Communication Disorders
Study Record Dates
First Submitted
April 13, 2011
First Posted
April 18, 2011
Study Start
April 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
November 25, 2013
Record last verified: 2013-11