Teacher PracticeNCT06729177
Single Case Research Design: Teacher Outcomes
A study testing Strategic and Interactive Signing Instruction in people with Teacher Practice, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
This study examines whether a professional development program helps teachers implement Strategic and Interactive Signing Instruction (SISI) with higher fidelity. The training includes review of an intervention manual, live modeling of SISI components, and discussion of implementation expectations. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Teacher Practice
- What is being tested?
- Strategic and Interactive Signing Instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Teachers of the deaf working in a school for the deaf across kindergarten to 3rd grade levels
Who cannot join
- Not teachers of the deaf working in a school for the deaf across kindergarten to 3rd grade levels
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee, Knoxville
Knoxville, Tennessee, 37996
About this study
Official title: Strategic and Interactive Signing Instruction
This study examines whether a professional development program helps teachers implement Strategic and Interactive Signing Instruction (SISI) with higher fidelity. The training includes review of an intervention manual, live modeling of SISI components, and discussion of implementation expectations. Teacher fidelity is evaluated with the Strategic and Interactive Signing Instruction Fidelity Tool, which rates the extent to which core components are used during a intervention session. The study also documents how often teachers receive additional support (e.g., coaching) to understand which procedures help strengthen implementation.
Read the detailed description
This project uses a nonconcurrent multiple-baseline design across four teachers who serve deaf children in a deaf education program. The goal is to examine changes in teachers' SISI implementation fidelity following training and coaching.
At baseline, the PI observes each teacher's typical language arts instruction using the SISI Fidelity Tool. Three stable data points are collected for each teacher before intervention. Every SISI component is scored as 1 (fully implemented), 0.5 (partially implemented), or 0 (not implemented), and then summarized as a percentage of components implemented.
After baseline, the PI provides a two-day training in SISI procedures. Teachers then begin implementing SISI in a staggered fashion: Teacher 1 starts immediately after training for three weeks; Teacher 2 begins in Week 4; Teachers 3 and 4 begin in Weeks 7 and 10. All instructional sessions are video-recorded and uploaded to a cloud platform, where the PI and a second rater review them for daily fidelity monitoring.
Throughout the study, the PI offers coaching as needed to support implementation. The PI also tracks children's progress on their individually targeted sign language skills to confirm that intervention adjustments are appropriate and timely. If implementation challenges arise or if data collection procedures are insufficiently clear or consistent, refinements may be made. Any refinements are put in place immediately and monitored for their influence on teacher fidelity and the feasibility of study procedures.
- Conditions
- Teacher Practice
- Being tested
- Strategic and Interactive Signing Instruction
- Keywords
- Sign Language, Deaf, Teacher Training
- 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, grounded in cognitive, sociocultural, and linguistic theories, are applied to interventions that support sign language development in deaf children.
| Study group | Role | What they receive |
|---|---|---|
| Single Case Research Design: Teacher 1 | Experimental | The PI worked with teachers to increase SISI implementation fidelity using a nonconcurrent multiple-baseline design across teacher participants. Four teachers who served deaf children were recruited from a school for the deaf. The SISI Fidelity Tool was used to observe teachers' business-as-usual language arts instruction and to establish three stable baseline data points for each teacher. Each SISI component was scored as 1 (fully implemented), 0.5 (partially implemented), or 0 (not implemented) and reported as the percentage of components implemented.
After baseline observations were completed, the PI provided a two-day training on SISI implementation. Teacher 1 began implementing SISI for three weeks following the training, Teacher 2 began in Week 4, and Teachers 3 and 4 began in Weeks 7 and 10, respectively. Receives: Behavioral: Strategic and Interactive Signing Instruction |
| Single Case Research Design: Teacher 2 | Experimental | The PI worked with teachers to increase SISI implementation fidelity using a nonconcurrent multiple-baseline design across teacher participants. Four teachers who served deaf children were recruited from a school for the deaf. The SISI Fidelity Tool was used to observe teachers' business-as-usual language arts instruction and to establish three stable baseline data points for each teacher. Each SISI component was scored as 1 (fully implemented), 0.5 (partially implemented), or 0 (not implemented) and reported as the percentage of components implemented.
After baseline observations were completed, the PI provided a two-day training on SISI implementation. Teacher 1 began implementing SISI for three weeks following the training, Teacher 2 began in Week 4, and Teachers 3 and 4 began in Weeks 7 and 10, respectively. Receives: Behavioral: Strategic and Interactive Signing Instruction |
| Single Case Research Design: Teacher 3 | Experimental | The PI worked with teachers to increase SISI implementation fidelity using a nonconcurrent multiple-baseline design across teacher participants. Four teachers who served deaf children were recruited from a school for the deaf. The SISI Fidelity Tool was used to observe teachers' business-as-usual language arts instruction and to establish three stable baseline data points for each teacher. Each SISI component was scored as 1 (fully implemented), 0.5 (partially implemented), or 0 (not implemented) and reported as the percentage of components implemented.
After baseline observations were completed, the PI provided a two-day training on SISI implementation. Teacher 1 began implementing SISI for three weeks following the training, Teacher 2 began in Week 4, and Teachers 3 and 4 began in Weeks 7 and 10, respectively. Receives: Behavioral: Strategic and Interactive Signing Instruction |
| Single Case Research Design: Teacher 4 | Experimental | The PI worked with teachers to increase SISI implementation fidelity using a nonconcurrent multiple-baseline design across teacher participants. Four teachers who served deaf children were recruited from a school for the deaf. The SISI Fidelity Tool was used to observe teachers' business-as-usual language arts instruction and to establish three stable baseline data points for each teacher. Each SISI component was scored as 1 (fully implemented), 0.5 (partially implemented), or 0 (not implemented) and reported as the percentage of components implemented.
After baseline observations were completed, the PI provided a two-day training on SISI implementation. Teacher 1 began implementing SISI for three weeks following the training, Teacher 2 began in Week 4, and Teachers 3 and 4 began in Weeks 7 and 10, respectively. Receives: Behavioral: Strategic and Interactive Signing Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
SISI Fidelity
The Strategic and Interactive Signing Instruction (SISI) Fidelity Tool is a 45-item observational checklist assessing adherence to the model-guided-independent cycle, scaffolding quality, and use of targeted ASL skills. Each item is rated from 0 to 1 (0 = not implemented, 0.5 = partially implemented, 1 = fully implemented). Scores are summed and converted to a percentage (0-100%). Higher scores indicate stronger fidelity of implementation.
Measured: Baseline began at the start of the school year for all participants. Because intervention start times were staggered in the multiple-baseline design, intervention duration ranged from approximately 12 to 40 weeks across participants.
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 start23 Aug 2024
- Primary completion1 Jul 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Teacher PracticeStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- This research uses the noncurrent multiple baseline design across teacher participants.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
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
- NCT06729177
- Sponsor's protocol ID
- 514092
- Other IDs
- 1R21DC021024-01A1
- Status last verified
- Sep 2025
- First submitted
- 5 Dec 2024
- Last updated
- 19 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic and Interactive Signing Instruction
- ClinicalTrials.gov ID
- NCT06729177
- Acronym / sponsor ID
- 514092
- Conditions
- Teacher Practice
- Keywords
- Sign Language, Deaf, Teacher Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Posted 19 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines whether a professional development program helps teachers implement Strategic and Interactive Signing Instruction (SISI) with higher fidelity. The training includes review of an intervention manual, live modeling of SISI components, and discussion of implementation expectations. Teacher fidelity is evaluated with the Strategic and Interactive Signing Instruction Fidelity Tool, which rates the extent to which core components are used during a intervention session. The study also documents how often teachers receive additional support (e.g., coaching) to understand which procedures help strengthen implementation.
Detailed description
This project uses a nonconcurrent multiple-baseline design across four teachers who serve deaf children in a deaf education program. The goal is to examine changes in teachers' SISI implementation fidelity following training and coaching.
At baseline, the PI observes each teacher's typical language arts instruction using the SISI Fidelity Tool. Three stable data points are collected for each teacher before intervention. Every SISI component is scored as 1 (fully implemented), 0.5 (partially implemented), or 0 (not implemented), and then summarized as a percentage of components implemented.
After baseline, the PI provides a two-day training in SISI procedures. Teachers then begin implementing SISI in a staggered fashion: Teacher 1 starts immediately after training for three weeks; Teacher 2 begins in Week 4; Teachers 3 and 4 begin in Weeks 7 and 10. All instructional sessions are video-recorded and uploaded to a cloud platform, where the PI and a second rater review them for daily fidelity monitoring.
Throughout the study, the PI offers coaching as needed to support implementation. The PI also tracks children's progress on their individually targeted sign language skills to confirm that intervention adjustments are appropriate and timely. If implementation challenges arise or if data collection procedures are insufficiently clear or consistent, refinements may be made. Any refinements are put in place immediately and monitored for their influence on teacher fidelity and the feasibility of study procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This research uses the noncurrent multiple baseline design across teacher participants.
| Arm | Type | Receives |
|---|---|---|
| Single Case Research Design: Teacher 1 | Experimental | Behavioral: Strategic and Interactive Signing InstructionThe PI worked with teachers to increase SISI implementation fidelity using a nonconcurrent multiple-baseline design across teacher participants. Four teachers who served deaf children were recruited from a school for the deaf. The SISI Fidelity Tool was used to observe teachers' business-as-usual language arts instruction and to establish three stable baseline data points for each teacher. Each SISI component was scored as 1 (fully implemented), 0.5 (partially implemented), or 0 (not implemented) and reported as the percentage of components implemented. After baseline observations were completed, the PI provided a two-day training on SISI implementation. Teacher 1 began implementing SISI for three weeks following the training, Teacher 2 began in Week 4, and Teachers 3 and 4 began in Weeks 7 and 10, respectively. |
| Single Case Research Design: Teacher 2 | Experimental | Behavioral: Strategic and Interactive Signing InstructionThe PI worked with teachers to increase SISI implementation fidelity using a nonconcurrent multiple-baseline design across teacher participants. Four teachers who served deaf children were recruited from a school for the deaf. The SISI Fidelity Tool was used to observe teachers' business-as-usual language arts instruction and to establish three stable baseline data points for each teacher. Each SISI component was scored as 1 (fully implemented), 0.5 (partially implemented), or 0 (not implemented) and reported as the percentage of components implemented. After baseline observations were completed, the PI provided a two-day training on SISI implementation. Teacher 1 began implementing SISI for three weeks following the training, Teacher 2 began in Week 4, and Teachers 3 and 4 began in Weeks 7 and 10, respectively. |
| Single Case Research Design: Teacher 3 | Experimental | Behavioral: Strategic and Interactive Signing InstructionThe PI worked with teachers to increase SISI implementation fidelity using a nonconcurrent multiple-baseline design across teacher participants. Four teachers who served deaf children were recruited from a school for the deaf. The SISI Fidelity Tool was used to observe teachers' business-as-usual language arts instruction and to establish three stable baseline data points for each teacher. Each SISI component was scored as 1 (fully implemented), 0.5 (partially implemented), or 0 (not implemented) and reported as the percentage of components implemented. After baseline observations were completed, the PI provided a two-day training on SISI implementation. Teacher 1 began implementing SISI for three weeks following the training, Teacher 2 began in Week 4, and Teachers 3 and 4 began in Weeks 7 and 10, respectively. |
| Single Case Research Design: Teacher 4 | Experimental | Behavioral: Strategic and Interactive Signing InstructionThe PI worked with teachers to increase SISI implementation fidelity using a nonconcurrent multiple-baseline design across teacher participants. Four teachers who served deaf children were recruited from a school for the deaf. The SISI Fidelity Tool was used to observe teachers' business-as-usual language arts instruction and to establish three stable baseline data points for each teacher. Each SISI component was scored as 1 (fully implemented), 0.5 (partially implemented), or 0 (not implemented) and reported as the percentage of components implemented. After baseline observations were completed, the PI provided a two-day training on SISI implementation. Teacher 1 began implementing SISI for three weeks following the training, Teacher 2 began in Week 4, and Teachers 3 and 4 began in Weeks 7 and 10, respectively. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Teachers of the deaf working in a school for the deaf across kindergarten to 3rd grade levels
Key exclusion criteria (1 listed)
- Not teachers of the deaf working in a school for the deaf across kindergarten to 3rd grade levels
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, grounded in cognitive, sociocultural, and linguistic theories, are applied to interventions that support sign language development in deaf children. | Behavioural | Single Case Research Design: Teacher 1, Single Case Research Design: Teacher 2, Single Case Research Design: Teacher 3, Single Case Research Design: Teacher 4 |
Primary outcome
SISI Fidelity
Time frame: Baseline began at the start of the school year for all participants. Because intervention start times were staggered in the multiple-baseline design, intervention duration ranged from approximately 12 to 40 weeks across participants.
The Strategic and Interactive Signing Instruction (SISI) Fidelity Tool is a 45-item observational checklist assessing adherence to the model-guided-independent cycle, scaffolding quality, and use of targeted ASL skills. Each item is rated from 0 to 1 (0 = not implemented, 0.5 = partially implemented, 1 = fully implemented). Scores are summed and converted to a percentage (0-100%). Higher scores indicate stronger fidelity of implementation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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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 in people with 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 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: finished, as of the sponsor's last update on 19 Dec 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?
Yes. Results are posted in the registry (first posted 19 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
SISI Fidelity (time frame: Baseline began at the start of the school year for all participants. Because intervention start times were staggered in the multiple-baseline design, intervention duration ranged from approximately 12 to 40 weeks across participants.). 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 19 Dec 2025.