DyslexiaNCT00061412
Comprehensive Program to Improve Reading and Writing Skills in At-Risk and Dyslexic Children
A study testing Comprehensive program to improve reading and writing skills in people with Dyslexia and Learning Disorders, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyslexia, Learning Disorders
- What is being tested?
- Comprehensive program to improve reading and writing skills
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1995to Nov 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Student in grades 1 to 9
- Underachieving in reading and writing
- English as first language
Who cannot join
- Mental retardation
- Developmental disability such as autism or pervasive developmental disorder
- Brain damage or disease affecting brain function
- Severe language or psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Learning Disabilities: Links to Schools and Biology
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.
Read the 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.
- Conditions
- Dyslexia, Learning Disorders
- Being tested
- Comprehensive program to improve reading and writing skills
- Keywords
- Low reading and writing achievement, At-risk students, Reading Disability, Writing Disability
- Medical subject headings
- Dyslexia, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive program to improve reading and writing skillsBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2003 (estimated)
- Study startDec 1995
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 2,500 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Virginia Berninger, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061412
- Sponsor's protocol ID
- 2P50HD33812-6
- Other IDs
- 2P50HD033812
- Status last verified
- Sep 2006
- First submitted
- 27 May 2003
- Last updated
- 28 Sep 2006
- Results posted
- No
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. doi: 10.1093/brain/awg026.
PubMed 12538414Richards 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.
PubMed 12427623Hsu 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.
PubMed 11992573Corina 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.
PubMed 11338191Berninger 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.
PubMed 10955205
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Disabilities: Links to Schools and Biology
- ClinicalTrials.gov ID
- NCT00061412
- Acronym / sponsor ID
- 2P50HD33812-6
- Conditions
- Dyslexia, Learning Disorders
- Keywords
- Low reading and writing achievement, At-risk students, Reading Disability, Writing Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Dec 1995
- Study completion
- Nov 2005
- First posted
- 28 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Student in grades 1 to 9
- Underachieving in reading and writing
- English as first language
Key exclusion criteria (4 listed)
- Mental retardation
- Developmental disability such as autism or pervasive developmental disorder
- Brain damage or disease affecting brain function
- Severe language or psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive program to improve reading and writing skills | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2006.
- Background: PubMed 12538414Eckert 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.
- Background: PubMed 12427623Richards 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.
- Background: PubMed 11992573Hsu 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.
- Background: PubMed 11338191Corina 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.
- Background: PubMed 10955205Berninger 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.
- Click here for more information on this trial.Link provided by the sponsor.
Related trials for Dyslexia
Active, not recruiting
Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity (ADHD)
Not yet recruiting
Immediate Effects of Active Prisms on Reading Automaticity and Motor Control in Young Adults With Developmental Dyslexia
Developmental Dyslexia
Active, not recruiting
Let's Know!2: Language-focused Intervention for Children at Risk of Comprehension Difficulties
Language Disorders in Children
Not yet recruiting
Brain Stimulation With Combined Reading and Motor Training for Children With Dyslexia
Developmental Dyslexia
Enrolling by invitation
Executive Function in Early Childhood
Reading Disability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Berninger, Ph.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive program to improve reading and writing skills in people with Dyslexia and Learning Disorders, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00061412, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2006; AzTrials last refreshed its copy on 31 Oct 2026.