Viewing Study NCT00061412



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Last Modification Date: 2024-10-26 @ 9:08 AM
Study NCT ID: NCT00061412
Status: COMPLETED
Last Update Posted: 2006-09-28
First Post: 2003-05-27

Brief Title: Comprehensive Program to Improve Reading and Writing Skills in At-Risk and Dyslexic Children
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD

Study Overview

Official Title: Learning Disabilities Links to Schools and Biology
Status: COMPLETED
Status Verified Date: 2006-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 brains 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None