Teaching BehaviorsSISINCT06667102
Strategic and Interactive Signing Instruction
A study testing Strategic and Interactive Signing Instruction in people with Teaching Behaviors and Sign Language Skills, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
Strategic and interactive approaches driven by sociocultural, cognitive, and language theories have accumulated a large body of evidence documenting improvements in more complex oral and written language skills. Read more about this study
- Who is it for?
- Ages 4 to 99 years
- Conditions the study is for
- Teaching Behaviors, Sign Language Skills
- 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
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2024to 30 Dec 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 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Deaf students in prekindergarten to 3rd grade classes
- Teachers of the deaf in prekindergarten to 3rd grade classes
Who cannot join
- Hearing students, deaf students aged 0-3 or 4th grade and beyond
- Non-teachers of the deaf or teachers of the deaf in 4th grade and beyond
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Tennessee, Knoxville
Knoxville, Tennessee, 37996
About this study
Official title: Strategic and Interactive Signing Instruction (SISI): An Intervention Program to Support Sign Language Development in Deaf Children
Strategic and interactive approaches driven by sociocultural, cognitive, and language theories have accumulated a large body of evidence documenting improvements in more complex oral and written language skills. Growing evidence demonstrates that more complex sign language skills positively predict literacy skills and may lead to improved health outcomes. This project involves new applications of theory-driven strategic and interactive approaches in an intervention program to target sign language development in deaf children between 5 and 8 years old who are at high risk of language delays.
Read the detailed description
Deaf children who reach the age of eight without a foundation in language have longitudinal struggles in the areas of receptive and expressive language, working memory, executive functions, literacy and academic skills, and behavioral, mental, social, and physical health. The lack of intervention programs targeting sign language competencies during the critical period of development is a critical barrier to making progress in preventing or addressing language delays in deaf children. Strategic and interactive approaches driven by sociocultural, cognitive, and language theories have accumulated a large body of evidence documenting improvements in more complex oral and written language skills. Cross-linguistic transfers between oral and writing skills within and across first and second languages are well-established in the literature. Taking these factors into account in addition to growing evidence that sign language skills positively predict literacy skills and may lead to improved health outcomes, it is critical to systematically support deaf children's sign language competences as early as possible. To address the identified critical barrier to progress, these are the aims of this project: (1) develop Strategic and Interactive Signing Instruction (SISI), an intervention program to target the development of sign language skills in deaf children aged 5-8; (2) refine SISI training and implementation protocols; and (3) test the efficacy of SISI in improving deaf children's sign language skills. First, a SISI manual will be developed for standardization and consistency in training, implementation, and fidelity. The SISI manual will include: (a) descriptions of strategic and interactive approaches and their new applications to develop sign language skills, (b) SISI intervention protocols, (c) SISI fidelity checklist, and (d) list of sign language skills that are targeted in SISI. Second, an experimental study will be conducted to assess the extent of training and support required from teachers to become proficient in SISI implementation. Meanwhile, child progress in meeting their target sign language skills will be monitored formatively, and modifications may be made in an iterative design fashion to strengthen the intervention design. Third, another experimental study will be applied to assess the efficacy of SISI in improving deaf children's sign language skills. Findings will provide robust data on the mechanisms of successful training dose, intervention design and fidelity, and data collection protocols in preparation for subsequent R01 application involving a large randomized controlled trial with sufficient statistical power to further strengthen evidence of SISI in improving deaf children's sign language skills along with examinations of cross-linguistic interactions in the written form. This project is innovative in its new applications of theory-driven strategic and interactive approaches to target sign language development in deaf children.
- Conditions
- Teaching Behaviors, Sign Language Skills
- Being tested
- Strategic and Interactive Signing Instruction
- Keywords
- Sign language, Teacher training, Language deprivation
- 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
SISI centers on deaf children producing sign language compositions to communicate their messages with identified audiences, and teachers utilizing strategic and interactive approaches to bring attention to target sign language skills by consciously monitoring and manipulating language to create desired meanings grounded in socially shared understandings.
| Study group | Role | What they receive |
|---|---|---|
| Improving Teacher Fidelity to SISI | Experimental | A noncurrent multiple baseline design across teacher participants will be utilized to assess the extent of support required by teachers to become proficient in SISI implementation. In this study, the independent variable is the SISI training, and the dependent variable is teacher fidelity to the SISI program as measured by the SISI fidelity checklist. Receives: Behavioral: Strategic and Interactive Signing Instruction |
| Control and Experimental Groups: SISI Efficacy | Experimental | This pre- and post- study provides baseline data on deaf children's sign language development prior to receiving SISI. Additionally, each participating teacher will submit a recorded instructional unit showcasing their best methods for supporting sign language development. This provides a further layer of baseline analysis, allowing the PI to assess the instructional methods already in use prior to SISI professional development and implementation. Demographic data for both teachers and students will also be collected in preparation for the quasi-experiment study.
Then, teachers will be assigned to either an experimental group, which will receive SISI professional development, or a control group that will continue with their usual teaching practices. In this quasi-experiment study, SISI's efficacy will be evaluated by comparing outcomes between the two groups. Receives: Behavioral: Strategic and Interactive Signing Instruction |
| Pre- and Post- Descriptive Study Data of Language Outcomes Children | Experimental | Up to 40 children from 4 classes will provide pre- and post-data in which they respond to a prompt in sign language on video. Receives: Behavioral: Strategic and Interactive Signing Instruction |
| Single Case Research Design: Deaf Children's Language Growth | Experimental | Single case research design will provide robust day-to-day data of causal relations between SISI and sign language skills. Given teachers' high fidelity in SISI implementation, a noncurrent multiple baseline design across child participants will be applied to assess the extent of SISI improving deaf children's target sign language skills in a year. The independent variable of this study is the SISI implementation, which is used to improve the dependent variables which will be target sign language skills. Receives: Behavioral: Strategic and Interactive Signing Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sign Language Skills
Deaf children's application of genre-based trait skills in sign language will be analyzed using rubrics adapted from the National Assessment of Educational Progress (NAEP) rubrics for standardized writing assessments.
Measured: From enrollment to the end of treatment 9 academic months later.
Teaching Behaviors
Teachers' fidelity to SISI will be measured through the fidelity instrument.
Measured: From enrollment to the end of treatment 9 academic months later.
Secondary outcomes (1)
Written Language
Deaf children's application of genre-based trait skills in written language will be analyzed using the emergent writing stages and rubrics adapted from the National Assessment of Educational Progress (NAEP) rubrics for 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 posted31 Oct 2024
- Study start23 Aug 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teaching BehaviorsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The PI will implement an experimental single case research design to track doses of SISI training and its efficacy in increasing teacher faithfulness to SISI. The PI will implement an experimental single case research design to identify causal relations between SISI and target sign language skills. The PI will implement a pre- and post- data to track deaf children's baseline growth in sign language skills prior to receiving SISI. The PI will implement a quasi-experimental study to identify the efficacy of SISI in improving deaf children's sign language skills.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667102
- Sponsor's protocol ID
- UTennesseeKnoxville
- Other IDs
- R21DC021024
- Acronym
- SISI
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data from interventions in all four arms (two single case research designs and two baseline / quasi-experimental designs) will be shared in .csv files.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic and Interactive Signing Instruction (SISI): An Intervention Program to Support Sign Language Development in Deaf Children
- ClinicalTrials.gov ID
- NCT06667102
- Acronym / sponsor ID
- SISI / UTennesseeKnoxville
- Conditions
- Teaching Behaviors, Sign Language Skills
- Keywords
- Sign language, Teacher training, Language deprivation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- 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
- 23 Aug 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 31 Oct 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.
Strategic and interactive approaches driven by sociocultural, cognitive, and language theories have accumulated a large body of evidence documenting improvements in more complex oral and written language skills. Growing evidence demonstrates that more complex sign language skills positively predict literacy skills and may lead to improved health outcomes. This project involves new applications of theory-driven strategic and interactive approaches in an intervention program to target sign language development in deaf children between 5 and 8 years old who are at high risk of language delays.
Detailed description
Deaf children who reach the age of eight without a foundation in language have longitudinal struggles in the areas of receptive and expressive language, working memory, executive functions, literacy and academic skills, and behavioral, mental, social, and physical health. The lack of intervention programs targeting sign language competencies during the critical period of development is a critical barrier to making progress in preventing or addressing language delays in deaf children. Strategic and interactive approaches driven by sociocultural, cognitive, and language theories have accumulated a large body of evidence documenting improvements in more complex oral and written language skills. Cross-linguistic transfers between oral and writing skills within and across first and second languages are well-established in the literature. Taking these factors into account in addition to growing evidence that sign language skills positively predict literacy skills and may lead to improved health outcomes, it is critical to systematically support deaf children's sign language competences as early as possible. To address the identified critical barrier to progress, these are the aims of this project: (1) develop Strategic and Interactive Signing Instruction (SISI), an intervention program to target the development of sign language skills in deaf children aged 5-8; (2) refine SISI training and implementation protocols; and (3) test the efficacy of SISI in improving deaf children's sign language skills. First, a SISI manual will be developed for standardization and consistency in training, implementation, and fidelity. The SISI manual will include: (a) descriptions of strategic and interactive approaches and their new applications to develop sign language skills, (b) SISI intervention protocols, (c) SISI fidelity checklist, and (d) list of sign language skills that are targeted in SISI. Second, an experimental study will be conducted to assess the extent of training and support required from teachers to become proficient in SISI implementation. Meanwhile, child progress in meeting their target sign language skills will be monitored formatively, and modifications may be made in an iterative design fashion to strengthen the intervention design. Third, another experimental study will be applied to assess the efficacy of SISI in improving deaf children's sign language skills. Findings will provide robust data on the mechanisms of successful training dose, intervention design and fidelity, and data collection protocols in preparation for subsequent R01 application involving a large randomized controlled trial with sufficient statistical power to further strengthen evidence of SISI in improving deaf children's sign language skills along with examinations of cross-linguistic interactions in the written form. This project is innovative in its new applications of theory-driven strategic and interactive approaches to target sign language development in deaf children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The PI will implement an experimental single case research design to track doses of SISI training and its efficacy in increasing teacher faithfulness to SISI. The PI will implement an experimental single case research design to identify causal relations between SISI and target sign language skills. The PI will implement a pre- and post- data to track deaf children's baseline growth in sign language skills prior to receiving SISI. The PI will implement a quasi-experimental study to identify the efficacy of SISI in improving deaf children's sign language skills.
| Arm | Type | Receives |
|---|---|---|
| Improving Teacher Fidelity to SISI | Experimental | Behavioral: Strategic and Interactive Signing InstructionA noncurrent multiple baseline design across teacher participants will be utilized to assess the extent of support required by teachers to become proficient in SISI implementation. In this study, the independent variable is the SISI training, and the dependent variable is teacher fidelity to the SISI program as measured by the SISI fidelity checklist. |
| Control and Experimental Groups: SISI Efficacy | Experimental | Behavioral: Strategic and Interactive Signing InstructionThis pre- and post- study provides baseline data on deaf children's sign language development prior to receiving SISI. Additionally, each participating teacher will submit a recorded instructional unit showcasing their best methods for supporting sign language development. This provides a further layer of baseline analysis, allowing the PI to assess the instructional methods already in use prior to SISI professional development and implementation. Demographic data for both teachers and students will also be collected in preparation for the quasi-experiment study. Then, teachers will be assigned to either an experimental group, which will receive SISI professional development, or a control group that will continue with their usual teaching practices. In this quasi-experiment study, SISI's efficacy will be evaluated by comparing outcomes between the two groups. |
| Pre- and Post- Descriptive Study Data of Language Outcomes Children | Experimental | Behavioral: Strategic and Interactive Signing InstructionUp to 40 children from 4 classes will provide pre- and post-data in which they respond to a prompt in sign language on video. |
| Single Case Research Design: Deaf Children's Language Growth | Experimental | Behavioral: Strategic and Interactive Signing InstructionSingle case research design will provide robust day-to-day data of causal relations between SISI and sign language skills. Given teachers' high fidelity in SISI implementation, a noncurrent multiple baseline design across child participants will be applied to assess the extent of SISI improving deaf children's target sign language skills in a year. The independent variable of this study is the SISI implementation, which is used to improve the dependent variables which will be target sign language skills. |
Who may qualify
- Ages
- 4 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Deaf students in prekindergarten to 3rd grade classes
- Teachers of the deaf in prekindergarten to 3rd grade classes
Key exclusion criteria (2 listed)
- Hearing students, deaf students aged 0-3 or 4th grade and beyond
- Non-teachers of the deaf or teachers of the deaf in 4th grade and beyond
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 InstructionSISI centers on deaf children producing sign language compositions to communicate their messages with identified audiences, and teachers utilizing strategic and interactive approaches to bring attention to target sign language skills by consciously monitoring and manipulating language to create desired meanings grounded in socially shared understandings. | Behavioural | Control and Experimental Groups: SISI Efficacy, Improving Teacher Fidelity to SISI, Pre- and Post- Descriptive Study Data of Language Outcomes Children, Single Case Research Design: Deaf Children's Language Growth |
Primary outcome
Sign Language Skills
Time frame: From enrollment to the end of treatment 9 academic months later.
Deaf children's application of genre-based trait skills in sign language will be analyzed using rubrics adapted from the National Assessment of Educational Progress (NAEP) rubrics for standardized writing assessments.
Teaching Behaviors
Time frame: From enrollment to the end of treatment 9 academic months later.
Teachers' fidelity to SISI will be measured through the fidelity instrument.
1 secondary outcome
Written Language
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 31 Oct 2024.
- Individual participant dataSharing planned: Yes. The data from interventions in all four arms (two single case research designs and two baseline / quasi-experimental designs) will be shared in .csv files.
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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.
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?
A study testing Strategic and Interactive Signing Instruction in people with Teaching Behaviors and 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 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: enrolling by invitation, as of the sponsor's last update on 31 Oct 2024. 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.). 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?
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 31 Oct 2024.