Hearing Loss, BilateralNCT06860022
Sentence Shaping - DHH
A study testing Shape Coding in people with Hearing Loss, Bilateral, run by Vanderbilt University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 15 years
- Conditions the study is for
- Hearing Loss, Bilateral
- What is being tested?
- Shape Coding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Adriana M Valtierra, M.S., 219-614-5980, adriana.m.valtierra@vanderbilt.edu
Adriana M Valtierra, M.S.
About this study
Official title: 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.
- Conditions
- Hearing Loss, Bilateral
- Being tested
- Shape Coding
- Medical subject headings
- Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shape CodingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Shape coding | Experimental | Intervention will be introducing and utilizing Shape Coding to construct sentences. Receives: Behavioral: Shape Coding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children for whom the intervention is successful
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.
Measured: Baseline to up to 8 weeks maximum
Secondary outcomes (3)
Proportion of children that generalize targeted skill to unpracticed words within targeted structure
The investigators will calculate the proportion of children that generalize the targeted skill to novel/unpracticed words within the targeted structure.
Measured: Baseline to up to 8 weeks maximum
Proportion of children that generalize targeted skill to unpracticed modality within targeted structure
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.
Measured: Baseline to up to 8 weeks maximum.
Proportion of children that maintain targeted skill after intervention has ended
The investigators will calculate the proportion of children that maintain higher percent accuracy after intervention is removed compared to baseline
Measured: Begins no more than 2 weeks after intervention phase ends; lasts up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start28 Aug 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, BilateralStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-case multiple probe across participants
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana M. Valtierra, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860022
- Sponsor's protocol ID
- 240927
- Status last verified
- Oct 2025
- First submitted
- 27 Feb 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentence Shaping: Written Language Intervention for Deaf and Hard of Hearing Middle Schoolers
- ClinicalTrials.gov ID
- NCT06860022
- Acronym / sponsor ID
- 240927
- Conditions
- Hearing Loss, Bilateral
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Mar 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-case multiple probe across participants
| Arm | Type | Receives |
|---|---|---|
| Shape coding | Experimental | Behavioral: Shape CodingIntervention will be introducing and utilizing Shape Coding to construct sentences. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
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 |
|---|---|---|
| Shape CodingIntervention 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. | Behavioural | Shape coding |
Primary outcome
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.
3 secondary outcomes
Proportion of children that generalize targeted skill to unpracticed words within targeted structure
Time frame: 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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shape Coding in people with Hearing Loss, Bilateral, run by Vanderbilt University 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adriana M Valtierra, M.S. (219-614-5980, adriana.m.valtierra@vanderbilt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children for whom the intervention is successful (time frame: Baseline to up to 8 weeks maximum). 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 25 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.