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出境医 / 临床实验 / University of Washington Reading & Dyslexia Research Program
University of Washington Reading & Dyslexia Research Program
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Reading Disability | Behavioral: preK |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 44 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | University of Washington Reading & Dyslexia Research Program |
| Estimated Study Start Date : | May 2019 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | June 2021 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Letters
Education program focuses on learning letters.
|
Behavioral: preK
Subjects enter and education program that either focuses on learning letters and their corresponding sounds or on language comprehension skills.
|
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Language
Education program focuses on language comprehension.
|
Outcome Measures
Primary Outcome Measures :
- 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
Eligibility Criteria
| Ages Eligible for Study: | 60 Months to 72 Months (Child) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Study Population
Typically developing children
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
Contacts and Locations
Contacts
| Contact: Patrick Donnelly | 206-685-9365 | pdonne@uw.edu |
Locations
| United States, Washington | |
| University of Washignton | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Contact: Jason Yeatman, PhD | |
Sponsors and Collaborators
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Principal Investigator: | Jason Yeatman, PhD | 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 |
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
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| 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 |
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| 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.
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
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.
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 60 Months to 72 Months (Child) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| 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 ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| 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 |
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| PRS Account | University of Washington | ||||
| Verification Date | May 2019 | ||||
