Sign Language SkillsNCT06724523
Pre- and Post- Descriptive Data of Language Outcomes in Deaf Children
An observational study of Sign Language Skills, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Sign Language Skills
- What is being tested?
- Business-as-usual instruction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 30 Jul 2025
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Deaf children between 4 and 10 years old attending deaf education programs
Who may be able to join
- Deaf children between 4 and 10 years old attending deaf education programs
Who cannot join
- Non-deaf children
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee, Knoxville
Knoxville, Tennessee, 37996
About this study
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.
- Conditions
- Sign Language Skills
- Being tested
- Business-as-usual instruction
- Keywords
- sign language, deaf, instruction
- Medical subject headings
- Sign Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Business-as-usual instructionBehavioural
Deaf children are receiving business-as-usual instruction in sign language in deaf education programs.
| Study group | Role | What they receive |
|---|---|---|
| Deaf children | Deaf children attending deaf education programs Receives: Behavioral: Business-as-usual instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sign Language Skills
Deaf children's sign language skills will be evaluated.
Measured: From enrollment to the end of treatment 9 academic months later.
Secondary outcomes (1)
Written Language Skills
Deaf children's written language skills will be evaluated.
Measured: From enrollment to the end of treatment 9 academic months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Aug 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sign Language SkillsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724523
- Sponsor's protocol ID
- 478856
- Other IDs
- R21DC021024
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- and Post- Descriptive Data of Language Outcomes in Deaf Children
- ClinicalTrials.gov ID
- NCT06724523
- Acronym / sponsor ID
- 478856
- Conditions
- Sign Language Skills
- Keywords
- sign language, deaf, instruction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deaf children | – | Behavioral: Business-as-usual instructionDeaf children attending deaf education programs |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Deaf children between 4 and 10 years old attending deaf education programs
Key inclusion criteria (1 listed)
- Deaf children between 4 and 10 years old attending deaf education programs
Key exclusion criteria (1 listed)
- Non-deaf children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Business-as-usual instructionDeaf children are receiving business-as-usual instruction in sign language in deaf education programs. | Behavioural | Deaf children |
Primary outcome
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.
1 secondary outcome
Written Language Skills
Time frame: From enrollment to the end of treatment 9 academic months later.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Sign Language Skills
Active, not recruiting
Strategic and Interactive Signing Instruction Experiment
Sign Language Skills, Teacher Practice
Enrolling by invitation
Strategic and Interactive Signing Instruction
Teaching Behaviors, Sign Language Skills
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sign Language Skills, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sign Language Skills (time frame: From enrollment to the end of treatment 9 academic months later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.