Sign Language SkillsNCT06729164
Strategic and Interactive Signing Instruction Experiment
A study testing Strategic and Interactive Signing Instruction and Business-As-Usual Instruction in people with Sign Language Skills and Teacher Practice, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
This RCT study involves teachers divided into an experimental group and a control group. Teachers in the experimental group will receive SISI training to support the sign language development of deaf children, while those in the control group will continue with "business-as-usual" teaching methods. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Sign Language Skills, Teacher Practice
- What is being tested?
- Strategic and Interactive Signing Instruction and Business-As-Usual Instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 30 Sep 2026
- Phase
- Interventional
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Deaf children in educational programs (aged 4-12)
- Teachers of the deaf working with deaf children
Who cannot join
- Non-deaf children
- Non teachers of the deaf
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee, Knoxville
Knoxville, Tennessee, 37996
About this study
Official title: Randomized Controlled Trial: Strategic and Interactive Signing Instruction
This RCT study involves teachers divided into an experimental group and a control group. Teachers in the experimental group will receive SISI training to support the sign language development of deaf children, while those in the control group will continue with "business-as-usual" teaching methods. Pre- and post-assessments will be conducted for all deaf children at the beginning and end of the school year.
Read the detailed description
This randomized controlled trial (RCT) examines the effects of the Strategic and Interactive Signing Instruction (SISI) intervention on deaf children's expressive language development in signing (primary) and writing (secondary). The study compares two groups - an intervention group implementing SISI and a control group continuing their usual instructional routines without the intervention.
The intervention group will include approximately 10 teachers, each working with 5-7 deaf children. These classrooms will implement the SISI intervention, which provides structured, language-centered supports designed to strengthen children's signing through explicit modeling, guided practice, and discourse-focused intervention routines. Schools that participated in the 2024-2025 nationwide pre/post study will be included in the intervention group for 2025-2026 if they choose to continue.
The control group will likewise include approximately 10 teachers with 5-7 Deaf children each. These classrooms will continue with their standard practices without the SISI intervention. Schools newly joining the project in 2025-2026 will be assigned to this group.
Child language data will be collected twice - fall 2025 (pre-test) and spring 2026 (post-test). Deaf children will complete three expressive language prompts representing major discourse types: personal narrative, informational report, and persuasive discourse. Their signed and written compositions will be analyzed using rubrics adapted from the National Assessment of Educational Progress (NAEP), focusing on growth in discourse-level skills.
The study hypothesizes that deaf children in the intervention group will show greater gains in expressive signing and writing than their peers in the control group. This hypothesis reflects the expectation that a systematic, discourse-oriented language intervention offers stronger support for language development than typical intervention routines.
This research aims to contribute to the evidence base on interventions that support deaf children's expressive language development. By examining child-level language outcomes from a discourse-focused intervention, the study will advance understanding of how structured language support can strengthen signing and writing development for deaf children.
- Conditions
- Sign Language Skills, Teacher Practice
- Being tested
- Strategic and Interactive Signing Instruction, Business-As-Usual Instruction
- Keywords
- Deaf, Sign language, Instruction, Intervention
- Medical subject headings
- Sign Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategic and Interactive Signing InstructionBehavioural
Evidence-based instructional methods guided by cognitive, sociocultural, and linguistic theories that are applied to interventions supporting sign language development among deaf children.
Business-As-Usual InstructionBehavioural
Teachers will teach business-as-usual without the inclusion of SISI.
| Study group | Role | What they receive |
|---|---|---|
| RCT - Experimental | Experimental | This RCT study involves teachers divided into an experimental group and a control group. Teachers in the experimental group will receive SISI training to support the sign language development of deaf children, while those in the control group will continue with "business-as-usual" teaching methods. Pre- and post-assessments will be conducted for all deaf children at the beginning and end of the school year. Receives: Behavioral: Strategic and Interactive Signing Instruction |
| Quasi-Experimental Study - Control | Placebo comparator | This quasi-experimental study involves teachers divided into an experimental group and a control group. Teachers in the experimental group will receive SISI training to support the sign language development of deaf children, while those in the control group will continue with "business-as-usual" teaching methods. Pre- and post-assessments will be conducted for all deaf children at the beginning and end of the school year. 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
Student data will be analyzed using rubrics adapted from the National Assessment of Educational Progress (NAEP) standardized writing assessments.
Measured: From enrollment to the end of treatment 9 academic months later.
Teacher Practice
The SISI Fidelity Tool, grounded in existing literature on evidence-based instructional methods, will be used to evaluate teachers' instructional practices.
Measured: From enrollment to the end of treatment 9 academic months later.
Secondary outcomes (1)
Written Language Skills
Student data will be analyzed using rubrics adapted from the National Assessment of Educational Progress (NAEP) standardized writing assessments.
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 posted11 Dec 2024
- Study start1 Apr 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
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
- Investigators
- Leala Holcomb, PhD, Principal investigator, Center of Deafness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729164
- Sponsor's protocol ID
- 451965
- Other IDs
- 1R21DC021024-01A1
- Status last verified
- Sep 2025
- First submitted
- 5 Dec 2024
- Last updated
- 28 Aug 2026
- 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.
Publications
Holcomb L, Eberwein AA. Teacher reports of ASL literacy instruction in deaf education. J Deaf Stud Deaf Educ. 2026 Jul 2;31(2):224-237. doi: 10.1093/jdsade/enaf060.
PubMed 41055392Holcomb L. Exploring signed literacy in elementary deaf students through evidence-based instructional methods. Sign Language Studies. 2024; 24(4):843-882.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Strategic and Interactive Signing Instruction
- ClinicalTrials.gov ID
- NCT06729164
- Acronym / sponsor ID
- 451965
- Conditions
- Sign Language Skills, Teacher Practice
- Keywords
- Deaf, Sign language, Instruction, Intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 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 Apr 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 11 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.
This RCT study involves teachers divided into an experimental group and a control group. Teachers in the experimental group will receive SISI training to support the sign language development of deaf children, while those in the control group will continue with "business-as-usual" teaching methods. Pre- and post-assessments will be conducted for all deaf children at the beginning and end of the school year.
Detailed description
This randomized controlled trial (RCT) examines the effects of the Strategic and Interactive Signing Instruction (SISI) intervention on deaf children's expressive language development in signing (primary) and writing (secondary). The study compares two groups - an intervention group implementing SISI and a control group continuing their usual instructional routines without the intervention.
The intervention group will include approximately 10 teachers, each working with 5-7 deaf children. These classrooms will implement the SISI intervention, which provides structured, language-centered supports designed to strengthen children's signing through explicit modeling, guided practice, and discourse-focused intervention routines. Schools that participated in the 2024-2025 nationwide pre/post study will be included in the intervention group for 2025-2026 if they choose to continue.
The control group will likewise include approximately 10 teachers with 5-7 Deaf children each. These classrooms will continue with their standard practices without the SISI intervention. Schools newly joining the project in 2025-2026 will be assigned to this group.
Child language data will be collected twice - fall 2025 (pre-test) and spring 2026 (post-test). Deaf children will complete three expressive language prompts representing major discourse types: personal narrative, informational report, and persuasive discourse. Their signed and written compositions will be analyzed using rubrics adapted from the National Assessment of Educational Progress (NAEP), focusing on growth in discourse-level skills.
The study hypothesizes that deaf children in the intervention group will show greater gains in expressive signing and writing than their peers in the control group. This hypothesis reflects the expectation that a systematic, discourse-oriented language intervention offers stronger support for language development than typical intervention routines.
This research aims to contribute to the evidence base on interventions that support deaf children's expressive language development. By examining child-level language outcomes from a discourse-focused intervention, the study will advance understanding of how structured language support can strengthen signing and writing development for deaf children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RCT - Experimental | Experimental | Behavioral: Strategic and Interactive Signing InstructionThis RCT study involves teachers divided into an experimental group and a control group. Teachers in the experimental group will receive SISI training to support the sign language development of deaf children, while those in the control group will continue with "business-as-usual" teaching methods. Pre- and post-assessments will be conducted for all deaf children at the beginning and end of the school year. |
| Quasi-Experimental Study - Control | Placebo comparator | Behavioral: Business-As-Usual InstructionThis quasi-experimental study involves teachers divided into an experimental group and a control group. Teachers in the experimental group will receive SISI training to support the sign language development of deaf children, while those in the control group will continue with "business-as-usual" teaching methods. Pre- and post-assessments will be conducted for all deaf children at the beginning and end of the school year. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Deaf children in educational programs (aged 4-12)
- Teachers of the deaf working with deaf children
Key exclusion criteria (2 listed)
- Non-deaf children
- Non teachers of the deaf
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 |
|---|---|---|
| Strategic and Interactive Signing InstructionEvidence-based instructional methods guided by cognitive, sociocultural, and linguistic theories that are applied to interventions supporting sign language development among deaf children. | Behavioural | RCT - Experimental |
| Business-As-Usual InstructionTeachers will teach business-as-usual without the inclusion of SISI. | Behavioural | Quasi-Experimental Study - Control |
Primary outcome
Sign Language Skills
Time frame: From enrollment to the end of treatment 9 academic months later.
Student data will be analyzed using rubrics adapted from the National Assessment of Educational Progress (NAEP) standardized writing assessments.
Teacher Practice
Time frame: From enrollment to the end of treatment 9 academic months later.
The SISI Fidelity Tool, grounded in existing literature on evidence-based instructional methods, will be used to evaluate teachers' instructional practices.
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 28 Aug 2026.
- Background: PubMed 41055392Holcomb L, Eberwein AA. Teacher reports of ASL literacy instruction in deaf education. J Deaf Stud Deaf Educ. 2026 Jul 2;31(2):224-237. doi: 10.1093/jdsade/enaf060.
- BackgroundHolcomb L. Exploring signed literacy in elementary deaf students through evidence-based instructional methods. Sign Language Studies. 2024; 24(4):843-882.
- Website about the research projectLink provided by the sponsor.
- 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 recruitingObservational study
Pre- and Post- Descriptive Data of Language Outcomes in Deaf Children
Sign Language Skills
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.
Leala Holcomb, PhD principal investigator
Center of Deafness
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategic and Interactive Signing Instruction and Business-As-Usual Instruction in people with Sign Language Skills and Teacher Practice, 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 2 inclusion and 2 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 28 Aug 2026. 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. Some participants in this study may receive a placebo. 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06729164, which also lists 2 linked publications.
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 28 Aug 2026.