Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comprehensive Program to Improve Reading and Writing Skills in At-Risk and Dyslexic Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00061412
Recruitment Status : Completed
First Posted : May 28, 2003
Last Update Posted : September 28, 2006
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Tracking Information
First Submitted Date  ICMJE May 27, 2003
First Posted Date  ICMJE May 28, 2003
Last Update Posted Date September 28, 2006
Study Start Date  ICMJE December 1995
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00061412 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE
  • Dyslexia
  • Learning Disorders
Intervention  ICMJE Behavioral: Comprehensive program to improve reading and writing skills
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
2500
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Student in grades 1 to 9
  • Underachieving in reading and writing
  • English as first language

Exclusion Criteria

  • Mental retardation
  • Developmental disability such as autism or pervasive developmental disorder
  • Brain damage or disease affecting brain function
  • Severe language or psychiatric disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00061412
Other Study ID Numbers  ICMJE 2P50HD33812-6
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Virginia Berninger, Ph.D. University of Washington
PRS Account Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP