- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06729177
Single Case Research Design: Teacher Outcomes
Strategic and Interactive Signing Instruction
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37996
- University of Tennessee, Knoxville
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Teachers of the deaf working in a school for the deaf across kindergarten to 3rd grade levels
Exclusion Criteria:
- Not teachers of the deaf working in a school for the deaf across kindergarten to 3rd grade levels
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single Case Research Design: Teacher 1
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. |
Evidence-based instructional methods, grounded in cognitive, sociocultural, and linguistic theories, are applied to interventions that support sign language development in deaf children.
|
|
Experimental: Single Case Research Design: Teacher 2
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. |
Evidence-based instructional methods, grounded in cognitive, sociocultural, and linguistic theories, are applied to interventions that support sign language development in deaf children.
|
|
Experimental: Single Case Research Design: Teacher 3
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. |
Evidence-based instructional methods, grounded in cognitive, sociocultural, and linguistic theories, are applied to interventions that support sign language development in deaf children.
|
|
Experimental: Single Case Research Design: Teacher 4
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. |
Evidence-based instructional methods, grounded in cognitive, sociocultural, and linguistic theories, are applied to interventions that support sign language development in deaf children.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Leala Holcomb, PhD, Center of Deafness
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 514092
- 1R21DC021024-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Teacher Practice
-
MDRCCompletedTeacher Practice | Child Social-Emotional DevelopmentUnited States
-
The University of Tennessee, KnoxvilleNational Institute on Deafness and Other Communication Disorders (NIDCD)Active, not recruitingTeacher Practice | Sign Language SkillsUnited States
-
NYU Langone HealthMakerere UniversityCompletedTeacher Mental Health Knowledge | Teacher Skills in Addressing Child Mental Health ProblemUganda
-
RANDdfusion IncCompleted
-
Istanbul University - CerrahpasaCompleted
-
Saavsus, Inc.Oregon Research InstituteRecruitingTeacher Self-efficacy for Teaching PE | Teacher PE Instruction | Student PE Enjoyment | Student Physical Activity | Student PE SatisfactionUnited States
-
Western Kentucky UniversityRecruitingUniversal Behavioral Supports | Teacher TrainingUnited States
-
Fundació Sant Joan de DéuFundació La Marató de TV3CompletedAutism Spectrum Disorder | Teacher Training | Developmental Disorders | Teacher Skills in Addressing Child Mental Health ProblemSpain
-
SEAMEO Regional Centre for Food and NutritionCompletedChildren Who Registered on the Selected Public Kindergarten and Agree to Follow the Study Assigned by Their Parents and TeacherIndonesia
-
Université de Reims Champagne-ArdenneNot yet recruitingGeneral PracticeFrance
Clinical Trials on Strategic and Interactive Signing Instruction
-
The University of Tennessee, KnoxvilleNational Institute on Deafness and Other Communication Disorders (NIDCD)Active, not recruiting
-
The University of Tennessee, KnoxvilleNational Institute on Deafness and Other Communication Disorders (NIDCD)Enrolling by invitationTeaching Behaviors | Sign Language SkillsUnited States
-
The University of Tennessee, KnoxvilleNational Institute on Deafness and Other Communication Disorders (NIDCD)Active, not recruitingTeacher Practice | Sign Language SkillsUnited States
-
National Taiwan University Hospital Hsin-Chu BranchTerminatedAnxiety | Nursing Education | Augmented Reality | ImmersiveTaiwan
-
Soroka University Medical CenterCompletedProportion of Anesthesia | Anxiety LevelIsrael
-
VA Pittsburgh Healthcare SystemUniversity of PittsburghCompleted
-
VA Office of Research and DevelopmentCompletedUse of Power Wheelchairs and Power Seat FunctionsUnited States
-
Universidad de AntioquiaUnknown
-
The University of Texas at DallasNational Institutes of Health (NIH)CompletedHearing ImpairedUnited States
-
Oregon Health and Science UniversityNot yet recruitingEarly Childhood Emotional and Behavioral Concerns