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University of Washington Reading & Dyslexia Research Program

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ClinicalTrials.gov Identifier: NCT03945097
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Jason Yeatman, University of Washington

Tracking Information
First Submitted Date April 26, 2019
First Posted Date May 10, 2019
Last Update Posted Date May 10, 2019
Estimated Study Start Date May 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title University of Washington Reading & Dyslexia Research Program
Official Title University of Washington Reading & Dyslexia Research Program
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Typically developing children
Condition Reading Disability
Intervention Behavioral: preK
Subjects enter and education program that either focuses on learning letters and their corresponding sounds or on language comprehension skills.
Study Groups/Cohorts
  • Letters
    Education program focuses on learning letters.
    Intervention: Behavioral: preK
  • Language
    Education program focuses on language comprehension.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 7, 2019)
44
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Months to 72 Months   (Child)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Patrick Donnelly 206-685-9365 pdonne@uw.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03945097
Other Study ID Numbers STUDY00000516
1R21HD092771-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jason Yeatman, University of Washington
Study Sponsor University of Washington
Collaborators Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Jason Yeatman, PhD University of Washington
PRS Account University of Washington
Verification Date May 2019