Pre- and Post- Descriptive Data of Language Outcomes in D... | NCT06724523

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

NCT06724523

Sponsor

The University of Tennessee, Knoxville

Status

Active, not recruiting

Last Update Posted

Jan 20, 2025Actual

Enrollment

160Estimated

Phase

Not provided

Conditions

Sign Language Skills

Interventions

Business-as-usual instruction

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R21DC021024	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2024Actual

Primary Completion Date

Jul 30, 2025Estimated

Completion Date

Jul 30, 2025Estimated

First Submitted Date

Dec 4, 2024

First Submission Date that Met QC Criteria

Dec 4, 2024

First Posted Date

Dec 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2025

Last Update Posted Date

Jan 20, 2025Actual

Name	Class
National Institute on Deafness and Other Communication Disorders (NIDCD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

9 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Deaf children		Deaf children attending deaf education programs	Behavioral: Business-as-usual instruction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Business-as-usual instruction	Behavioral	Deaf children are receiving business-as-usual instruction in sign language in deaf education programs.	Deaf children

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Non-deaf children

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Tennessee, Knoxville		Knoxville	Tennessee	37996	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Study Protocol
Clinical Study Report (CSR)
Analytic Code

Time Frame

December, 2026 to December, 2036

Access Criteria

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

URL

Not provided

Type	Date	Date Unknown
Release	Oct 9, 2025
Unrelease	Nov 4, 2025
Release	Nov 18, 2025
Reset	Dec 11, 2025

Submission Tracking

Estimated Results First Submitted Date

Oct 9, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 9, 2025	Nov 4, 2025
Nov 18, 2025

Condition Browse Module

MeSH Terms

ID	Term
D012813	Sign Language

Ancestor Terms

ID	Term
D007802	Language
D003142	Communication
D001519	Behavior
D008369	Manual Communication

Browse Leaves

Not provided

Browse Branches

Not provided