Reading DisabilityNCT03945097
University of Washington Reading & Dyslexia Research Program
An observational study of Reading Disability, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 to 72 months
- Conditions the study is for
- Reading Disability
- What is being tested?
- preK
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- May 2019to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 72 months
- All sexes
- Child
Study population: Typically developing children
Who may be able to join
None listed.
Who cannot join
- Reported neurological or psychiatric condition.
- Claustrophobia. ADHD
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washignton
Seattle, Washington, 98195
Jason Yeatman, PhD
About this study
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.
- Conditions
- Reading Disability
- Being tested
- preK
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preKBehavioural
Subjects enter and education program that either focuses on learning letters and their corresponding sounds or on language comprehension skills.
| Study group | Role | What they receive |
|---|---|---|
| Letters | Education program focuses on learning letters. Receives: Behavioral: preK | |
| Language | Education program focuses on language comprehension. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 2 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study startMay 2019 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reading DisabilityStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jason Yeatman, University of Washington
- Investigators
- Jason Yeatman, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945097
- Sponsor's protocol ID
- STUDY00000516
- Other IDs
- 1R21HD092771-01A1
- Status last verified
- May 2019
- First submitted
- 26 Apr 2019
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Washington Reading & Dyslexia Research Program
- ClinicalTrials.gov ID
- NCT03945097
- Acronym / sponsor ID
- STUDY00000516
- Conditions
- Reading Disability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letters | – | Behavioral: preKEducation program focuses on learning letters. |
| Language | – | –Education program focuses on language comprehension. |
Who may qualify
- Ages
- 60 to 72 months
- Sex
- All
- Age groups
- Child
- Study population
- Typically developing children
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Reported neurological or psychiatric condition.
- Claustrophobia. ADHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preKSubjects enter and education program that either focuses on learning letters and their corresponding sounds or on language comprehension skills. | Behavioural | Letters |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Individual participant dataSharing planned: No
Related trials for Reading Disability
Enrolling by invitation
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
Recruiting
Personalization of Visual Characters and Text-to-Speech (TTS) to Support Learning in Students With Reading Difficulties
Developmental Dyslexia, Reading Problem
Recruiting
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
Developmental Dyslexia, Developmental Language Disorder
Active, not recruiting
Promoting Caregiver Implementation of an Effective Early Learning Intervention
Developmental Language Disorder, Reading; Difficult
Active, not recruiting
Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity (ADHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Yeatman, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reading Disability, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Donnelly (206-685-9365, pdonne@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Letter Knowledge (time frame: Within 2 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.