NCT06724523

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

August 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

January 20, 2025

Status Verified

December 1, 2024

Enrollment Period

12 months

First QC Date

December 4, 2024

Last Update Submit

January 16, 2025

Conditions

Keywords

sign languagedeafinstruction

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Written Language Skills

    From enrollment to the end of treatment 9 academic months later.

Study Arms (1)

Deaf children

Deaf children attending deaf education programs

Behavioral: Business-as-usual instruction

Interventions

Deaf children are receiving business-as-usual instruction in sign language in deaf education programs.

Deaf children

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Non-deaf children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee, Knoxville

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

Sign Language

Condition Hierarchy (Ancestors)

LanguageCommunicationBehaviorManual CommunicationNonverbal Communication

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 9, 2024

Study Start

August 1, 2024

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

January 20, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, 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.

Locations