University of Washington Reading & Dyslexia Research Program | NCT03945097

Studies
University of Washington Reading & Dyslexia Research Program

NCT03945097

Sponsor

University of Washington

Status

Unknown status

Last Update Posted

May 10, 2019Actual

Enrollment

44Estimated

Phase

Not provided

Conditions

Reading Disability

Interventions

preK

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R21HD092771-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2019Estimated

Primary Completion Date

Jun 2021Estimated

Completion Date

Jun 2021Estimated

First Submitted Date

Apr 26, 2019

First Submission Date that Met QC Criteria

May 7, 2019

First Posted Date

May 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2019

Last Update Posted Date

May 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jason Yeatman, Assistant Professor, Institute for Learning & Brain Sciences, Dept. of Speech & Hearing Services, University of WashingtonPrincipal Investigator

Lead Sponsor

University of WashingtonOTHER

Collaborators

Name	Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Letters		Education program focuses on learning letters.	Behavioral: preK
Language		Education program focuses on language comprehension.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
preK	Behavioral	Subjects enter and education program that either focuses on learning letters and their corresponding sounds or on language comprehension skills.	Letters

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Months

Maximum Age

72 Months

Standard Ages

Child

Study Population

Typically developing children

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick Donnelly	Contact	206-685-9365		pdonne@uw.edu

Overall Officials

Name	Affiliation	Role
Jason Yeatman, PhD	University of Washington	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Washignton	Recruiting	Seattle	Washington	98195	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004410	Dyslexia

Ancestor Terms

ID	Term
D007806	Language Disorders
D003147	Communication Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided