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

NCT ID: NCT00061412

Last Updated: 2006-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-12-31

Study Completion Date

2005-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyslexia Learning Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Comprehensive program to improve reading and writing skills

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

NIH

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Virginia Berninger, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Washington

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1093/brain/awg026.

Reference Type BACKGROUND
PMID: 12538414 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12427623 (View on PubMed)

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. doi: 10.1002/ajmg.10523.

Reference Type BACKGROUND
PMID: 11992573 (View on PubMed)

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. doi: 10.1097/00001756-200105080-00029.

Reference Type BACKGROUND
PMID: 11338191 (View on PubMed)

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. doi: 10.1207/S15326942DN1702_06.

Reference Type BACKGROUND
PMID: 10955205 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2P50HD033812

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2P50HD33812-6

Identifier Type: -

Identifier Source: org_study_id