Study Results
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.
COMPLETED
NA
24 participants
INTERVENTIONAL
2019-02-15
2019-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Over half of elementary school students in the United States are reading below grade level compared to their same age peers. Children with poor reading skills are more likely to experience academic and behavioral problems. When students are not reading at grade level by 4th grade, they are more likely to experience future academic failure, school dropout, juvenile delinquency, teenage pregnancy, and under- or unemployment in adulthood. Traditional methods of classroom large group instruction require children to sit quietly and concentrate on small print for extended periods of time. Many children experience frustration and agitation in response to such reading demands.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers
NCT04059939
Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach
NCT00110292
Literacy Instruction Through Media for Everyone
NCT06796790
Comprehensive Program to Improve Reading and Writing Skills in At-Risk and Dyslexic Children
NCT00061412
Efficacy of Let's Know! First Grade
NCT06945289
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Despite the preponderance of data expounding a literacy crisis in the US, the status quo of reading instruction in US elementary schools has not been effective in remediating functional illiteracy. In classrooms averaging 21.6 students, teachers are unable to provide the individualized instruction that is necessary to meet the learning needs of at-risk students. Reading specialists who work with children one-on-one and in small groups employ methods similar to those of classroom teachers, requiring children to sit quietly and sustain their attention on small print. These demands are difficult for children experiencing challenges with self-regulation, and school environments requiring these behaviors for several hours each day may inculcate feelings of frustration and failure in the children who most need to develop a sense of self-efficacy as readers with full membership in the world of print. In this study, twenty-four first graders will be assigned by chance to a reading or no-reading group.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention Group (Reading Program)
First graders who will receive the 10-week reading program (a total of 20 hours), twice weekly in 1-hour sessions, and will continue to receive typical classroom reading instruction.
10-week Reading Program
Intervention sessions will be carried out during the school day in a private school room. In each session, the investigator will work with the child individually to help him or her read better. Intervention will incorporate word recognition and phonetic decoding of words established as meeting 1st grade essential literacy standards. Learning techniques will involve games, play, movement, music, and breaks (i.e., the child is able to move about and associate words with color, video, and music. Three 5-minute breaks will be integrated into each 1-hour session to allow the child time to rest and process learned material). Intervention will also use each child's personal interests as a context around which sight words will be learned.
Control Group
First graders who will not take part in the reading program but will continue to receive typical classroom reading instruction.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
10-week Reading Program
Intervention sessions will be carried out during the school day in a private school room. In each session, the investigator will work with the child individually to help him or her read better. Intervention will incorporate word recognition and phonetic decoding of words established as meeting 1st grade essential literacy standards. Learning techniques will involve games, play, movement, music, and breaks (i.e., the child is able to move about and associate words with color, video, and music. Three 5-minute breaks will be integrated into each 1-hour session to allow the child time to rest and process learned material). Intervention will also use each child's personal interests as a context around which sight words will be learned.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Between 6-7 years old
* Identified by teachers as reading below 1st grade level
Exclusion Criteria
6 Years
7 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Columbia University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sharon Gutman
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sharon Gutman, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of Rehabilitation and Regenerative Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NYC Elementary Public School (recruitment location)
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bennett IM, Frasso R, Bellamy SL, Wortham S, Gross KS. Pre-teen literacy and subsequent teenage childbearing in a US population. Contraception. 2013 Apr;87(4):459-64. doi: 10.1016/j.contraception.2012.08.020. Epub 2012 Dec 11.
Related Links
Access external resources that provide additional context or updates about the study.
Hernandez, D. J. (2012). Double jeopardy: How third-grade reading skills and poverty influence high school graduation.
National Center for Educational Statistics. (2012). Schools and staffing survey.
Nation's Report Card. (2017). Data tools: State performance compared to the nation.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AAAR8813
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.