- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03945097
University of Washington Reading & Dyslexia Research Program
May 7, 2019 updated by: Jason Yeatman, University of Washington
Subjects are recruited for a pre-kindergarten education program focusing on early literacy skills.
Primary outcomes are improvement in letter knowledge and changes in brain response to text.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
44
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Patrick Donnelly
- Phone Number: 206-685-9365
- Email: pdonne@uw.edu
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- Recruiting
- University of Washignton
-
Contact:
- Jason Yeatman, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 6 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Typically developing children
Description
Inclusion Criteria: Typically developing children enrolled before kindergarten.
- Typically developing child between 60 and 72 months of age
- Has not yet begun Kindergarten
Exclusion Criteria:
- Reported neurological or psychiatric condition.
- Claustrophobia. ADHD
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Letters
Education program focuses on learning letters.
|
Subjects enter and education program that either focuses on learning letters and their corresponding sounds or on language comprehension skills.
|
Language
Education program focuses on language comprehension.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Letter Knowledge
Time Frame: Within 2 weeks post intervention
|
Knowledge of letter names and sounds.
This is computed as percent correct (out of 52).
Each child is shown a flash card with each upper case letter and asked to name it and say its sound
|
Within 2 weeks post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jason Yeatman, PhD, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2019
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
June 1, 2021
Study Registration Dates
First Submitted
April 26, 2019
First Submitted That Met QC Criteria
May 7, 2019
First Posted (Actual)
May 10, 2019
Study Record Updates
Last Update Posted (Actual)
May 10, 2019
Last Update Submitted That Met QC Criteria
May 7, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000516
- 1R21HD092771-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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