DyslexiaPhase 3NCT00065832
Reading Problems in Children Living in Urban Areas
A Phase 3 study testing Reading Instruction in people with Dyslexia, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Trial summary
The first line of defense against reading disabilities is good classroom reading instruction. This study describes how characteristics of students, teachers, and instruction relate to academic achievement in inner-city kindergarten through Grade 4 classrooms. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslexia
- What is being tested?
- Reading Instruction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,400 participants
- Where
- No sites listed yet
- Study dates
- Jul 1993to Jun 2002
- Phase
- Phase 3
- 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Student in participating school
- Kindergarten through Grade 4
Who cannot join
None listed.
About this study
Official title: Early Interventions for Children With Reading Problems
The first line of defense against reading disabilities is good classroom reading instruction. This study describes how characteristics of students, teachers, and instruction relate to academic achievement in inner-city kindergarten through Grade 4 classrooms.
Read the detailed description
Recent studies show that the incidence of reading disability can be significantly reduced by improving classroom instruction. Effective reading instruction in the primary grades includes explicit instruction in the alphabetic principle, reading for meaning, and opportunities to practice reading and writing. To learn more about the development of literacy skills in urban settings, students in 17 schools in Houston and Washington, D.C., were followed from kindergarten through Grade 4. Schools were selected based on similar demographics: predominantly African-American student population (95%) and high participation in the federal lunch program (85% to 100%). Each school was provided with grade-appropriate reading programs that focused on phonics and spelling. These programs included direct, integrated, classroom, and individual instruction modules.
Approximately 1400 children and 114 teachers participated each year in this four-year study. The design was cross-sequential so that the majority of teachers in a grade participated for two years. All children participating in regular education were included in the study. Children below the 25th percentile on a standardized reading test were tutored individually by retired teachers, using materials from the classroom reading program. A variety of reading curricula were in place in the classrooms across these two sites. In order to help teachers implement these materials effectively, an ongoing research-based professional development model was employed, with curriculum consultants and coaches working with the teachers in the classroom. Researchers observed in each classroom four to six times during the year using on-the-minute recordings of content. Observers also completed ratings of teaching competencies. Teachers completed surveys of knowledge, experience, attitudes, and instructional strategies. A random selection of eight to ten students were assessed four times during the year for growth in literacy-related skills and once at the end of the year for achievement in reading, spelling, and writing.
- Conditions
- Dyslexia
- Being tested
- Reading Instruction
- Keywords
- Reading disabilities, Inner-city, Urban
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading InstructionBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2003 (estimated)
- Study startJul 1993
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 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
- Barbara R. Foorman, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065832
- Sponsor's protocol ID
- 5R01HD30995-9
- Other IDs
- 5R01HD030995
- Status last verified
- Oct 2004
- First submitted
- 1 Aug 2003
- Last updated
- 3 Jun 2015
- Results posted
- No
Publications
Foorman BR, Anthony J, Seals L, Mouzaki A. Language development and emergent literacy in preschool. Semin Pediatr Neurol. 2002 Sep;9(3):173-84. doi: 10.1053/spen.2002.35497.
PubMed 12350038Fletcher, J.M., Foorman, B.R., Boudousquie, A., Barnes, M., Schatschneider, C., & Francis, D.J. (2002). Assessment of reading and learning disabilities: A research-based, treatment-oriented approach. Journal of School Psychology, 40, 27-63.
Rayner K, Foorman BR, Perfetti CA, Pesetsky D, Seidenberg MS. How should reading be taught? Sci Am. 2002 Mar;286(3):84-91. doi: 10.1038/scientificamerican0302-84. No abstract available.
PubMed 11857904Foorman, B.R., Francis, D.J., Fletcher, J.M., Schatschneider, C., & Mehta, P. (1998). The role of instruction in learning to read: Preventing reading failure in at-risk children. Journal of Educational Psychology, 90, 37-55.
Fletcher, J.M., Foorman, B.R., Francis, D.J., & Schatschneider, C. (Winter, 1997). Prevention of reading failure. Insight, 22-23.
Foorman, B. R. (Ed.) (2003). Preventing and Remediating Reading Difficulities: Bringing Science to Scale. Timonium, MD: York Press.
Foorman BR, Breier JI, Fletcher JM. Interventions aimed at improving reading success: an evidence-based approach. Dev Neuropsychol. 2003;24(2-3):613-39. doi: 10.1080/87565641.2003.9651913.
PubMed 14561564Foorman, B.R., Chen, D.T., Carlson, C., Moats, L., Francis, D.J., & Fletcher, J. (2003). The necessity of the alphabetic principle to phonemic awareness instruction. Reading and Writing, 16, 289-324.
Foorman, B.R., Fletcher, J.M., & Francis, D.J. (2004). Early reading assessment. In W.M. Evers & H.J. Walberg (Eds.), Testing student learning, evaluating teaching effectiveness (pp. 81-125). Stanford, CA: The Hoover Institution.
Foorman, B.R., Fletcher, J.M., & Francis, D.J. (1999). Beginning reading is strategic and by design multi-level. Issues in Education: Contributions from Educational Psychology, 5, 65-75.
Foorman, B.R., Fletcher, J.M., & Francis, D.J. (1998). Preventing reading failure by ensuring effective reading instruction. In S. Patton & M. Holmes (Eds.), The keys to literacy. Washington, D.C.: Council for Basic Education.
Foorman, B.R., Francis, D.J., Beeler, T., Winikates, D., & Fletcher, J.M. (1997). Early interventions for children with reading problems: Study designs and preliminary findings. Learning Disabilities: A Multidisciplinary Journal, 8, 63-71.
Foorman, B.R., Francis, D.J., Davidson, K., Harm, M., & Griffin, J. (2004). Variability in text features in six grade 1 basal reading programs. Scientific Studies in Reading, 8(2), 167-197.
Foorman, B.R., Francis, D.J., Fletcher, J.M., & Schatschneider, C. (2000). Misrepresentation of research by other researchers. Educational Researcher, 29, 27-37.
Foorman, B.R., Francis, D.J., Fletcher, J.M., Schatschneider, C., & Mehta, P. (1998). The role of instruction in learning to read: Preventing reading failure in at-risk children. Journal of Educational Psychology, 90, 37-55. [Reprinted in Wray, D. (Ed.) (2004). Major Themes in Education. London, UK: Routledge.]
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Interventions for Children With Reading Problems
- ClinicalTrials.gov ID
- NCT00065832
- Acronym / sponsor ID
- 5R01HD30995-9
- Conditions
- Dyslexia
- Keywords
- Reading disabilities, Inner-city, Urban
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jul 1993
- Study completion
- Jun 2002
- First posted
- 4 Aug 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.
The first line of defense against reading disabilities is good classroom reading instruction. This study describes how characteristics of students, teachers, and instruction relate to academic achievement in inner-city kindergarten through Grade 4 classrooms.
Detailed description
Recent studies show that the incidence of reading disability can be significantly reduced by improving classroom instruction. Effective reading instruction in the primary grades includes explicit instruction in the alphabetic principle, reading for meaning, and opportunities to practice reading and writing. To learn more about the development of literacy skills in urban settings, students in 17 schools in Houston and Washington, D.C., were followed from kindergarten through Grade 4. Schools were selected based on similar demographics: predominantly African-American student population (95%) and high participation in the federal lunch program (85% to 100%). Each school was provided with grade-appropriate reading programs that focused on phonics and spelling. These programs included direct, integrated, classroom, and individual instruction modules.
Approximately 1400 children and 114 teachers participated each year in this four-year study. The design was cross-sequential so that the majority of teachers in a grade participated for two years. All children participating in regular education were included in the study. Children below the 25th percentile on a standardized reading test were tutored individually by retired teachers, using materials from the classroom reading program. A variety of reading curricula were in place in the classrooms across these two sites. In order to help teachers implement these materials effectively, an ongoing research-based professional development model was employed, with curriculum consultants and coaches working with the teachers in the classroom. Researchers observed in each classroom four to six times during the year using on-the-minute recordings of content. Observers also completed ratings of teaching competencies. Teachers completed surveys of knowledge, experience, attitudes, and instructional strategies. A random selection of eight to ten students were assessed four times during the year for growth in literacy-related skills and once at the end of the year for achievement in reading, spelling, and writing.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Student in participating school
- Kindergarten through Grade 4
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Reading Instruction | 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 3 Jun 2015.
- Background: PubMed 12350038Foorman BR, Anthony J, Seals L, Mouzaki A. Language development and emergent literacy in preschool. Semin Pediatr Neurol. 2002 Sep;9(3):173-84. doi: 10.1053/spen.2002.35497.
- BackgroundFletcher, J.M., Foorman, B.R., Boudousquie, A., Barnes, M., Schatschneider, C., & Francis, D.J. (2002). Assessment of reading and learning disabilities: A research-based, treatment-oriented approach. Journal of School Psychology, 40, 27-63.
- Background: PubMed 11857904Rayner K, Foorman BR, Perfetti CA, Pesetsky D, Seidenberg MS. How should reading be taught? Sci Am. 2002 Mar;286(3):84-91. doi: 10.1038/scientificamerican0302-84. No abstract available.
- BackgroundFoorman, B.R., Francis, D.J., Fletcher, J.M., Schatschneider, C., & Mehta, P. (1998). The role of instruction in learning to read: Preventing reading failure in at-risk children. Journal of Educational Psychology, 90, 37-55.
- BackgroundFletcher, J.M., Foorman, B.R., Francis, D.J., & Schatschneider, C. (Winter, 1997). Prevention of reading failure. Insight, 22-23.
- BackgroundFoorman, B. R. (Ed.) (2003). Preventing and Remediating Reading Difficulities: Bringing Science to Scale. Timonium, MD: York Press.
- Background: PubMed 14561564Foorman BR, Breier JI, Fletcher JM. Interventions aimed at improving reading success: an evidence-based approach. Dev Neuropsychol. 2003;24(2-3):613-39. doi: 10.1080/87565641.2003.9651913.
- BackgroundFoorman, B.R., Chen, D.T., Carlson, C., Moats, L., Francis, D.J., & Fletcher, J. (2003). The necessity of the alphabetic principle to phonemic awareness instruction. Reading and Writing, 16, 289-324.
- BackgroundFoorman, B.R., Fletcher, J.M., & Francis, D.J. (2004). Early reading assessment. In W.M. Evers & H.J. Walberg (Eds.), Testing student learning, evaluating teaching effectiveness (pp. 81-125). Stanford, CA: The Hoover Institution.
- BackgroundFoorman, B.R., Fletcher, J.M., & Francis, D.J. (1999). Beginning reading is strategic and by design multi-level. Issues in Education: Contributions from Educational Psychology, 5, 65-75.
- BackgroundFoorman, B.R., Fletcher, J.M., & Francis, D.J. (1998). Preventing reading failure by ensuring effective reading instruction. In S. Patton & M. Holmes (Eds.), The keys to literacy. Washington, D.C.: Council for Basic Education.
- BackgroundFoorman, B.R., Francis, D.J., Beeler, T., Winikates, D., & Fletcher, J.M. (1997). Early interventions for children with reading problems: Study designs and preliminary findings. Learning Disabilities: A Multidisciplinary Journal, 8, 63-71.
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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.
Barbara R. Foorman principal investigator
University of Texas
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reading Instruction in people with Dyslexia, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
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 2 inclusion and 0 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 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NCT00065832, which also lists 36 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 3 Jun 2015.