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Trial record 3 of 18 for: reading | NICHD

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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00061412

First Posted: May 28, 2003

Last Update Posted: September 28, 2006

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.

Information provided by:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

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.

Condition	Intervention
Dyslexia Learning Disorders	Behavioral: Comprehensive program to improve reading and writing skills


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single Primary Purpose: Treatment
Official Title:	Learning Disabilities: Links to Schools and Biology

Resource links provided by NLM:

MedlinePlus related topics: Learning Disorders

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):


Estimated Enrollment:	2500
Study Start Date:	December 1995
Estimated Study Completion Date:	November 2005

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	6 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061412

Locations


United States, Washington
University of Washington
Seattle, Washington, United States

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators


Principal Investigator:	Virginia Berninger, Ph.D.	University of Washington

More Information

Additional Information:

Click here for more information on this trial. This link exits the ClinicalTrials.gov site

Publications:

Eckert MA, Leonard CM, Richards TL, Aylward EH, Thomson J, Berninger VW. Anatomical correlates of dyslexia: frontal and cerebellar findings. Brain. 2003 Feb;126(Pt 2):482-94.

Richards TL, Berninger VW, Aylward EH, Richards AL, Thomson JB, Nagy WE, Carlisle JF, Dager SR, Abbott RD. Reproducibility of proton MR spectroscopic imaging (PEPSI): comparison of dyslexic and normal-reading children and effects of treatment on brain lactate levels during language tasks. AJNR Am J Neuroradiol. 2002 Nov-Dec;23(10):1678-85.

Hsu L, Wijsman EM, Berninger VW, Thomson JB, Raskind WH. Familial aggregation of dyslexia phenotypes. II: paired correlated measures. Am J Med Genet. 2002 May 8;114(4):471-8.

Corina DP, Richards TL, Serafini S, Richards AL, Steury K, Abbott RD, Echelard DR, Maravilla KR, Berninger VW. fMRI auditory language differences between dyslexic and able reading children. Neuroreport. 2001 May 8;12(6):1195-201.

Berninger VW, Abbott RD, Brooksher R, Lemos Z, Ogier S, Zook D, Mostafapour E. A connectionist approach to making the predictability of English orthography explicit to at-risk beginning readers: evidence for alternative, effective strategies. Dev Neuropsychol. 2000;17(2):241-71.


ClinicalTrials.gov Identifier:	NCT00061412 History of Changes
Other Study ID Numbers:	2P50HD33812-6
First Submitted:	May 27, 2003
First Posted:	May 28, 2003
Last Update Posted:	September 28, 2006
Last Verified:	September 2006

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):


Low reading and writing achievement At-risk students Reading Disability Writing Disability

Additional relevant MeSH terms:


Dyslexia Learning Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations	Neurologic Manifestations Nervous System Diseases Signs and Symptoms Neurodevelopmental Disorders Mental Disorders

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