NCT06860022

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Aug 2025Oct 2026

First Submitted

Initial submission to the registry

February 27, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

August 28, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

7 months

First QC Date

February 27, 2025

Last Update Submit

October 20, 2025

Conditions

Outcome Measures

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.

    Baseline to up to 8 weeks maximum

Secondary Outcomes (3)

  • Proportion of children that generalize targeted skill to unpracticed words within targeted structure

    Baseline to up to 8 weeks maximum

  • Proportion of children that generalize targeted skill to unpracticed modality within targeted structure

    Baseline to up to 8 weeks maximum.

  • Proportion of children that maintain targeted skill after intervention has ended

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

Study Arms (1)

Shape coding

EXPERIMENTAL

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

Behavioral: Shape Coding

Interventions

Shape CodingBEHAVIORAL

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.

Shape coding

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Bilateral

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Adriana M Valtierra, M.S.

CONTACT

Jena McDaniel, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-case multiple probe across participants
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 5, 2025

Study Start

August 28, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

October 22, 2025

Record last verified: 2025-10

Locations