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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03945097
Other study ID # STUDY00000516
Secondary ID 1R21HD092771-01A
Status Recruiting
Phase
First received
Last updated
Start date May 2019
Est. completion date June 2021

Study information

Verified date May 2019
Source University of Washington
Contact Patrick Donnelly
Phone 206-685-9365
Email pdonne@uw.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date June 2021
Est. primary completion date June 2021
Accepts healthy volunteers
Gender All
Age group 60 Months to 72 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
preK
Subjects enter and education program that either focuses on learning letters and their corresponding sounds or on language comprehension skills.

Locations

Country Name City State
United States University of Washignton Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Letter Knowledge 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
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