ClinicalTrials.gg
RecruitingNCT06860022Updated Aug 25, 2026

Sentence Shaping - DHH

An interventional study of Shape Coding in Hearing Loss, Bilateral, sponsored by Vanderbilt University. Recruiting at 1 site in United States. Open to participants aged 9 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
9 Years to 15 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hearing Loss, Bilateral
03

In context

Hearing Loss, Bilateral

55 studies on the registry are indexed under Hearing Loss, Bilateral; 17 are open to participants now.

This study's planned enrollment of 30 is close to the median of 30 across 42 interventional studies indexed under Hearing Loss, Bilateral.

Browse Hearing Loss, Bilateral studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 522 studies on the registry; 20 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Shape coding

    Intervention will be introducing and utilizing Shape Coding to construct sentences.

    Behavioral: Shape Coding

Interventions

  • BehavioralShape Coding

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to up to 8 weeks maximum

Secondary outcomes

  1. 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.

    Time frame: Baseline to up to 8 weeks maximum

  2. 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.

    Time frame: Baseline to up to 8 weeks maximum.

  3. 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

    Time frame: Begins no more than 2 weeks after intervention phase ends; lasts up to 3 weeks

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Nov 2026, 15 months after the start.

Of 27 interventional studies with no phase under Hearing Loss, Bilateral, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 60. This study's planned 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2025
First posted
Mar 5, 2025
StartActual
Aug 28, 2025
Primary completionEst.
Nov 2026
CompletionEst.
Dec 2026
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06860022
Responsible party
Adriana M. Valtierra (Principal Investigator, Vanderbilt University) — Principal investigator
First posted
Mar 5, 2025
Start date
Aug 28, 2025
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Aug 25, 2026

Study contacts

Adriana M Valtierra, M.S.
Contact
adriana.m.valtierra@vanderbilt.edu
219-614-5980
Jena McDaniel, PhD
Contact
jena.mcdaniel@vumc.org
615-936-5114

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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