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| Tracking Information | |||||
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| First Received Date ICMJE | May 27, 2003 | ||||
| Last Updated Date | September 27, 2006 | ||||
| Start Date ICMJE | December 1995 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00061412 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comprehensive Program to Improve Reading and Writing Skills in At-Risk and Dyslexic Children | ||||
| Official Title ICMJE | Learning Disabilities: Links to Schools and Biology | ||||
| Brief Summary | This project is evaluating programs to improve reading and writing skills in children who have or are at risk for having reading disabilities. The project focuses on children who are at-risk for low achievement in school and on children with dyslexia. |
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| Detailed Description | This study is part of a larger project to investigate the biological and educational constraints operating in children with learning disabilities, with a focus on treatment and links between assessment and treatment. The project evaluates prevention and treatment of reading and writing disabilities, the genetic contribution to subtypes of dyslexia, the relationship between brain variables and dyslexia, and the brain's response to treatment for dyslexia. Genetic and brain imaging studies occur throughout the project. During Year 1, at-risk readers in first grade were targeted for an intervention for mapping spoken words onto written words. These students were compared to a control group. During Year 2, the faster responders (those who reached grade level) and the slower responders (those who were not yet at grade level) from Year 1 were compared. Slower responders received additional treatment and comparisons were made again at the end of the year. The additional treatment was also studied in Spanish-speaking students in first grade. During Year 3, another group of at-risk, poor readers in second grade were randomized to either word decoding treatment, comprehension treatment, a combined word decoding and comprehension treatment, or a control treatment. During Year 4, readers at risk for failing state standards in reading (decoding) participated in an extended day program providing comprehensive reading instruction. The students were compared to a control group. During Year 5, all students grades 4 to 9 took a battery of morphological, reading, and writing tests. The testing was administered throughout an entire school system. During Year 6, older students with dyslexia were randomly assigned to phonological or morphological reading training. Students were then compared on pre- and post-test behavioral measures and brain activation results. During Year 7, students with dyslexia were randomly assigned to an orthographic or morphological treatment for spelling. Students underwent brain imaging before and after the intervention. Behavioral and brain activation measures were also assessed. During Year 8, students with dyslexia underwent attention or fluency training and writing training with and without attentional bridges. Only behavioral measures were collected. Recruitment of families for the family genetics study is ongoing. Recruitment for the brain imaging-treatment studies will begin in 2004 when installation of new brain imaging equipment is complete. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Comprehensive program to improve reading and writing skills | ||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 2500 | ||||
| Completion Date | November 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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| Gender | Both | ||||
| Ages | 6 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00061412 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 2P50HD33812-6 | ||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Verification Date | September 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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