NCT03945097

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

2.1 years

First QC Date

April 26, 2019

Last Update Submit

May 7, 2019

Conditions

Reading Disability

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Letters

Education program focuses on learning letters.

Behavioral: preK

Language

Education program focuses on language comprehension.

Interventions

preKBEHAVIORAL

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

Letters

Eligibility Criteria

Age60 Months - 72 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Typically developing children

You may qualify if:

  • Typically developing child between 60 and 72 months of age
  • Has not yet begun Kindergarten

You may not qualify if:

  • Reported neurological or psychiatric condition.
  • Claustrophobia. ADHD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washignton

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Jason Yeatman, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Donnelly

CONTACT

206-685-9365pdonne@uw.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Institute for Learning & Brain Sciences, Dept. of Speech & Hearing Services

Study Record Dates

First Submitted

April 26, 2019

First Posted

May 10, 2019

Study Start

May 1, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

May 10, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)