- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06860022
Sentence Shaping - DHH
October 20, 2025 updated by: Adriana M. Valtierra, Vanderbilt University
Sentence Shaping: Written Language Intervention for Deaf and Hard of Hearing Middle Schoolers
The proposed research addresses a long-standing and important challenge of improving literacy skills of children who are deaf and hard of hearing, a historically under researched group.
The investigators aim to leverage shape coding - an empirically validated intervention approach for constructing sentences in spoken English - for improving how efficiently children who are deaf and hard of hearing learn to correctly construct sentences in written English.
To advance the promising yet underutilized research on shape coding, the investigators complete the next logical step of applying the visual supports provided with shape coding to written language for deaf and hard of hearing children.
Shape coding has been effective for teaching sentence structure in spoken English to children with language disabilities and has recently been applied to sentence structure in American Sign Language with deaf and hard of hearing children.
Intervention involving shape coding is predicted to result in increased accuracy of word order in sentences in written English because deaf and hard of hearing children often benefit from visual information.
The investigators will accomplish this aim using single case multiple probe across participants design studies with 30 fifth through eighth grade children who are deaf and hard of hearing.
The knowledge gained will guide language and literacy intervention for children who are deaf and hard of hearing.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Adriana M Valtierra, M.S.
- Phone Number: 219-614-5980
- Email: adriana.m.valtierra@vanderbilt.edu
Study Contact Backup
- Name: Jena McDaniel, PhD
- Phone Number: 615-936-5114
- Email: jena.mcdaniel@vumc.org
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University Medical Center
-
Contact:
- Adriana M Valtierra, M.S.
- Phone Number: 219-614-5980
- Email: adriana.m.valtierra@vanderbilt.edu
-
Principal Investigator:
- Adriana M Valtierra, M.S.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Children in grades five through eight
- deaf or hard of hearing
- use spoken English and American Sign Language (ASL)
- bilateral hearing loss
- the ability to read and understand the grammatical structures of interest
- already be writing sentences, but demonstrate errors in word order and/or grammar.
Exclusion Criteria:
- diagnosis of dyslexia
- uncorrected vision impairment (i.e., identified vision loss without use of corrective lenses that interferes with eligibility evaluation tasks)
- evidence of severe motor impairment (i.e., insufficient motor skills to complete eligibility evaluation tasks independently).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Shape coding
Intervention will be introducing and utilizing Shape Coding to construct sentences.
|
Intervention will include introducing and reviewing the relevant shapes from Shape Coding and the order in which the shapes go in a sentence.
The researcher will then model how to put the word tiles in order according to the shapes.
Next the researcher and student work together to construct sentences.
The student is then given the opportunity to independently construct sentences using the word tiles and Shape Coding.
At the end of instruction, the researcher and student review the shapes and the student has the opportunity to independently construct sentences without shape coding.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of children for whom the intervention is successful
Time Frame: Baseline to up to 8 weeks maximum
|
The investigators will calculate the proportion of children for whom the intervention is successful, defined as at least 80% accuracy for 3 consecutive data collection days.
|
Baseline to up to 8 weeks maximum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of children that generalize targeted skill to unpracticed words within targeted structure
Time Frame: Baseline to up to 8 weeks maximum
|
The investigators will calculate the proportion of children that generalize the targeted skill to novel/unpracticed words within the targeted structure.
|
Baseline to up to 8 weeks maximum
|
|
Proportion of children that generalize targeted skill to unpracticed modality within targeted structure
Time Frame: Baseline to up to 8 weeks maximum.
|
The investigators will calculate the proportion of children that generalize the targeted skill to an unpracticed modality (i.e., writing, typing) using practiced words within the targeted structure.
|
Baseline to up to 8 weeks maximum.
|
|
Proportion of children that maintain targeted skill after intervention has ended
Time Frame: Begins no more than 2 weeks after intervention phase ends; lasts up to 3 weeks
|
The investigators will calculate the proportion of children that maintain higher percent accuracy after intervention is removed compared to baseline
|
Begins no more than 2 weeks after intervention phase ends; lasts up to 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2025
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
February 27, 2025
First Submitted That Met QC Criteria
February 27, 2025
First Posted (Actual)
March 5, 2025
Study Record Updates
Last Update Posted (Estimated)
October 22, 2025
Last Update Submitted That Met QC Criteria
October 20, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 240927
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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