Pre- and Post- Descriptive Data of Language Outcomes in Deaf Children

January 16, 2025 updated by: The University of Tennessee, Knoxville
Deaf children between ages of 4-10 will provide pre and post data by responding to three prompts in sign language and written language at the beginning and end of a year. This data will provide information on the developmental trends and characteristics of deaf children who will receive SISI the following year.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • University of Tennessee, Knoxville

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

Sampling Method

Probability Sample

Study Population

Deaf children between 4 and 10 years old attending deaf education programs

Description

Inclusion Criteria:

  • Deaf children between 4 and 10 years old attending deaf education programs

Exclusion Criteria:

  • Non-deaf children

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Deaf children
Deaf children attending deaf education programs
Behavioral: Business-as-usual instruction
Deaf children are receiving business-as-usual instruction in sign language in deaf education programs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sign Language Skills
Time Frame: From enrollment to the end of treatment 9 academic months later.
Deaf children's sign language skills will be evaluated.
From enrollment to the end of treatment 9 academic months later.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Written Language Skills
Time Frame: From enrollment to the end of treatment 9 academic months later.
Deaf children's written language skills will be evaluated.
From enrollment to the end of treatment 9 academic months later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Tennessee, Knoxville

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

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 1, 2024

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 478856
  • R21DC021024 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Under a data-sharing agreement that is in compliance with the internal policy at UTK, non-identifying data can be shared with other researchers for a minimum of 10 years on the University of Tennessee Research and Creative Exchange (TRACE). The raw data consists of videos of teachers, which will not be shared to maintain confidentiality. The processed data will be in the form of percentages for individual teachers across an academic year documented in a .csv file (Excel). Center for Open Science Foundation (OSF) is a free and open source project management tool that supports researchers throughout their entire project lifecycle. OSF also allows people to locate this data through project names, author names, and study keywords.

IPD Sharing Time Frame

December, 2026 to December, 2036

IPD Sharing Access Criteria

Researchers may contact the principal investigator for additional supporting information not available on OSF.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE
  • CSR

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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