Strategic and Interactive Signing Instruction
Phase: NA
Conditions: Teacher Practice
Sponsor: The University of Tennessee, Knoxville

 
 
 
 
 
 
 
ClinicalTrials.gov Study Document 
 
Official Title: Single Case Research Design: Teacher Outcomes 
 
NCT Number: NCT06729177 
 
Unique Protocol ID: 514092 
 
Document Type: Study Protocol, Statistical Analysis Plan, Family Consent Form, Teacher Consent Form 
 
Document Date: 2025-10-07 
 
Principal Investigator: Leala Holcomb, Ph.D., University of Tennessee 
 
This document is provided to meet NIH and ClinicalTrials.gov posting requirements under 42 C
 

 
Background and Rationale​
Signing deaf children often do not receive explicit intervention to improve signed language skills. Strategic and 
Interactive Signing Instruction (SISI) is an intervention program that supports signing skills by having teachers 
guide children in planning, producing, and refining sign language videos in ways that elevate discourse 
structures. SISI draws on evidence-based practices adapted for a visual language modality, such as genre 
study, strategy instruction for composing, and gradual release through modeled, shared, and independent 
signing. Prior pilot work indicated that teachers could use SISI with support but reported needing clearer 
guidance, examples, and coaching to implement signing-based intervention with fidelity. High-quality 
professional development with embedded coaching is a plausible way to strengthen teachers’ implementation 
of SISI.​
 
Objectives and Hypotheses​
Evaluate whether professional development in SISI increases teachers’ fidelity of implementation of 
signing-based intervention practices with deaf children.​
 
Secondary Objectives: (a) Estimate interrater reliability of the SISI Fidelity Tool. 
(b) Document teachers’ perceptions of the feasibility, usefulness, and acceptability of SISI (social validity).​
 
Primary Hypothesis: Teacher fidelity to SISI will increase immediately following PD + coaching, relative to their 
baseline signing intervention routines​
 
Secondary Hypothesis: Interrater agreement will fall in the good–excellent range; teachers will report positive 
social validity.​
 
Study Design​
Design: Nonconcurrent multiple-baseline single-case research design (SCRD) across four teachers 
(participants). The independent variable is PD + bi-weekly coaching; the dependent variable is teacher SISI 
fidelity. Staggered PD onset establishes experimental control.​
 
Setting: Deaf education program (K-3).​
 
Staggered PD Start Dates: Teacher 1: Oct 6, 2024; Teacher 2: Nov 9, 2024; Teacher 3: Dec 14, 2024; Teacher 
4: Mar 1, 2025.​
 
Duration: One academic year.​
 
Participants and Eligibility​
Teacher Participants (n=4): K-3 classroom teachers in a deaf education program; all are deaf and fluent ASL 
users (three White women; one Black man). Three hold master’s degrees in deaf education; one holds a 
bachelor’s degree (non-education) with provisional credential. Experience ranges 2-20+ years; classes serve 
4-5 students.​
 
Inclusion Criteria: Early-elementary classroom teacher in the program; ASL-fluent; agreement to video-record 
lessons and attend PD/coaching.​
 
Exclusion Criteria: Inability to participate in PD/coaching or to allow instructional video capture.​
 
 

 
Student Participants: Classroom students participate naturally as part of instruction; no student outcomes are 
formally analyzed in this protocol (focus is teacher outcomes). 
 
Participant Flow 
This study used a single-case research design (multiple baseline across participants) involving four teacher 
participants. Because the design focuses on individual replication rather than group-level enrollment, the 
standard concept of “participant flow” does not apply. All four teachers completed the study, and no attrition 
occurred. 
Table: 
Period 
Started Completed 
Discontinued 
Baseline Phase 
4 
4 
0 
Intervention 
Phase 
4 
4 
0 
The design involves repeated observations for each participant rather than cohort enrollment. No participants 
withdrew or were excluded after enrollment. 
Interventions (Independent Variable)​
Professional Development: 10 hours across two days, in classrooms, led by the PI, focusing on the SISI 
manual’s 45 indicators..​
 
Coaching: Bi-weekly virtual coaching sessions post-PD: review recent instruction (uploaded videos), plan 
upcoming lessons, troubleshoot implementation.​
 
Curricular Integration: SISI is woven into school-mandated American Reading Company (ARC) pacing guides 
(e.g., narrative units on animals; informational units on bugs), maintaining required topics while targeting sign 
language skills.​
 
Procedures and Data Collection​
Video Capture: Daily lessons recorded via iPads and uploaded to a secure cloud platform (Swivl) for 
observation and fidelity scoring.​
 
Units:​
 • Baseline phase- Teachers maintain typical language arts routines. For each teacher, ≥7 baseline instructional 
“units” are sampled. If no composing unit is present, a single language arts class is scored per the protocol 
fallback rule.​
 • Intervention phase- After PD, teachers implement full SISI composing units; ≥2 intervention units per teacher 
are sampled.​
 
Fidelity Tool: 45 indicators, scored 0 (not implemented), 0.5 (partial), 1 (full). Indicators require engagement in 
sign language composing using videos for credit. Total scores are converted to percentages per unit.​
 
 

 
Interrater Reliability: A trained, independent rater double-codes a stratified random sample of units (baseline 
and intervention). Disagreements adjudicated for analytic data; IRR computed on unreconciled ratings.​
 
Outcome Measures​
Primary Outcome: Teacher SISI Fidelity (%), computed per unit from the 45-item instrument. Visual analysis 
examines level, trend, variability, immediacy, and maintenance across phases.​
 
Secondary Outcomes:​
 • Interrater Reliability: item-level exact agreement and quadratic-weighted κ on unit totals.​
 • Social Validity: Semi-structured end-of-year interviews (30 minutes, in ASL) on value, feasibility, coaching 
satisfaction, improvement suggestions, and future intentions.​
 
Sample Size and Replications​
Four participants (teachers) with staggered baseline lengths provide ≥3 demonstrations of effect required for 
functional relation decisions in SCRD.​
 
Statistical/Analytic Plan​
Primary Analysis: Visual analysis per SCRD standards (Kratochwill et al., 2010): changes in 
level/trend/variability; immediacy following intervention onset; maintenance; and three replications across 
baselines. Baseline points represent single lessons sampled non-sequentially (x-axis spacing nominal). 
Intervention points represent composing units spanning multiple weeks (x-axis spacing approximates unit 
duration).​
 
Effect Sizes: Log response ratio (increasing; LRRi) calculated for each teacher (Pustejovsky, 2018; 
Single-Case Effect Size Calculator v0.7.3). Benchmarks: small 0.5, medium 1.0, large ≥1.5.​
 
IRR: Item-level agreement (%) and quadratic-weighted κ with 95% CI on unit-level totals.​
 
Social Validity: Thematic summary of interview responses.​
 
Results Summary 
Fidelity: Baseline near-zero (no sign language composition on videos); immediate post-PD jump to 45-60% on 
first unit; three teachers rose to 80-90% by study end; one maintained 60%. Baseline variability minimal; 
intervention variability low when fidelity ≥80%, with maintenance across final two units for each teacher.​
 
Effect Sizes (LRRi): Teacher 1 = 3.72 (SE 0.05); Teacher 2 = 3.71 (0.06); Teacher 3 = 2.04 (0.22); Teacher 4 = 
3.36 (0.04) - all large, consistent gains.​
 
Interrater Reliability: Item-level exact agreement 90.8%; quadratic-weighted κ = 0.88 (95% CI 0.85-0.91). 
Teacher-specific κ: 0.86 (T1), 0.99 (T2), 0.90 (T3), 0.80 (T4).​
 
Social Validity: All teachers valued SISI, reported feasibility, and intended to expand use next year; coaching 
and sign language composition on videos were highlighted as helpful. Technology (video editing) required extra 
support for some.​
 
Adverse Events 
 
 

 
Serious Adverse Events: None reported. 
 
Other (Non-Serious) Adverse Events: None reported. 
 
This was a minimal-risk, educational intervention involving professional development and instructional 
coaching for teachers. No physical, psychological, or social adverse events occurred. No participants withdrew 
due to adverse experiences. Monitoring was conducted by the Principal Investigator through bi-weekly 
meetings. 
 
Risk/Benefit Assessment​
Risk: Minimal risk related to confidentiality of instructional videos.​
 
Mitigation: De-identification (alphanumeric IDs); restricted, password-protected storage and access; removal of 
direct identifiers; no public posting of identifiable content.​
 
Benefit: Teachers receive PD and coaching likely to improve evidence-based language intervention; potential 
indirect benefit to child engagement and more sign language opportunities.​
 
Data Management and Confidentiality​
 • Secure cloud upload (in transit/at rest encryption).​
 • Access limited to named research personnel.​
 • Linkage file with identifiers stored separately on restricted volume.​
 • Analytic datasets de-identified.​
 • Retention per institutional policy; destruction per policy after retention period.​
 
Monitoring​
Given the minimal-risk, education-focused design, no independent DSMB is constituted. The PI monitors 
protocol adherence, data quality, and privacy protections.​
 
Ethics​
IRB approval obtained from the University of Tennessee. Teacher and family consent procedures are 
documented in separate consent forms. Participation is voluntary; withdrawal permitted at any time without 
penalty. 
 
 

 
 
Dear Parent or Guardian:  
 
Project Information 
The purpose of this research project is to investigate the impact of signing instruction on deaf students’ sign 
language skills. This project will be conducted during this academic year. Your consent will make it possible 
for your child to participate in the research project. 
 
Data Collection 
●​ From the teacher: (1) Video-recorded instructional sessions and (2) Teacher demographic survey;  
Family and child demographic survey (e.g., hearing level, language use)  
●​ From your child: (1) Video-recorded signed responses and written responses to questions (e.g., 
what is your favorite thing to do?). 
 
Videotaping in Classrooms 
In order to capture aspects of your child and their teacher’s involvement in SISI, instructional sessions 
during signing instruction time will be video recorded. Videos will be uploaded and stored on a secure server 
that can only be accessed by me. Therefore, if you decline for your child to be videotaped, your child may 
not participate in the research. With added consents from you and your child’s teacher (optional), classroom 
video footage may be used for conferences and professional development purposes.  
 
Confidentiality & Potential Risks 
This is a federally funded grant program, and as such, final research data will be publicly accessible to others 
for a minimum of 10 years on the University of Tennessee Research and Creative Exchange. Data may be 
used for future studies or shared with other researchers for use in future studies without obtaining additional 
informed consent from you or others. However, any identifiable information will not be shared or revealed. This 
means the names of your school, teachers, and students will not ever be shown to respect confidentiality. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This 
website will not include information that can identify you. At most, the website will include a summary of the 
results. You can search this website at any time. 
 
While the breach of confidentiality of data is always a potential risk to research, I will take steps to minimize 
this. Participants and their associated data will be represented with pseudonyms or alphanumeric IDs that do 
not contain identifying information. Video data will be viewed only by researchers involved in this project. 
Further, specific information, such as names or programs, will not be disclosed in published papers or 
presentations. Data with identifying information will only be shared within the researchers. These data will be 
saved on password-protected computers and a password-protected server. Any paper documents will be 
scanned and uploaded and then immediately destroyed. 
 
Potential Benefits 
This study presents potential benefits to your child, and to the field of deaf education and language 
development. Your child has potential to make gains in sign language skills. The analysis of student progress 
made while engaged in signing instruction could provide the field with valuable information about the 
effectiveness of this instructional approach. 
 
 

 
Discontinuing Participation 
At any time, you may request to withdraw your consent or discontinue your child’s participation. Your requests 
will be honored promptly and unconditionally without penalty, and any data collected from you will be 
immediately destroyed.  
 
Questions 
If you have any questions about this study, please contact Leala Holcomb, Principal Investigator, email: 
lholcom5@utk.edu. If you have any questions or concerns regarding your rights as a study participant, or if 
you are dissatisfied at any time with any aspect of this  study, you may contact the UT Office of Research 
IRB Compliance Officer at (865) 974-7697 or at utkirb@utk.edu.  
 
Sincerely,  
 
 
Leala Holcomb, Ph.D.  
University of Tennessee 
 
 
 
 
Name of child: _________________________________________________  
 
 
Your name (please print): _________________________________________________  
 
 
 
Your signature below indicates your consent to have your child participate in this study. 
 
 
Signature: __________________________________________  Date: ____________  
 
 
 
Optional: Your signature below indicates your consent to have your child’s video footage shown in 
future professional development given to other teachers. 
 
 
Signature: __________________________________________  Date: ____________  
 
 
 

 
Dear Teacher: 
 
Project Information 
The purpose of this 2-year research project is to investigate the impact of signing instruction on deaf 
students’ sign language skills. This project will be conducted during an academic year. Your consent will 
enable you and your students to participate in the research project. 
 
Teacher Participation 
●​ You will receive a two-day professional development on signing instruction followed by bi-weekly 
coaching sessions to implement signing instruction with deaf students. 
 
Year 1 and Year 2 Data Collection 
●​ From the teacher: (1) Video-recorded instructional sessions and (2) Teacher demographic survey;  
Family and child demographic survey (e.g., hearing level, language use)  
●​ From the students: (1) Video-recorded signed compositions after each instructional session. 
 
Videotaping in Classrooms 
In order to capture aspects of your involvement in signing instruction, all instructional sessions will be video 
recorded. Videos will be uploaded and stored on a secure server that can only be accessed by me. Therefore, 
if you decline to be videotaped, you may not participate in the research. With added consents from you and 
your students (optional), classroom video footage may be used for conferences and professional development 
purposes.  
 
Confidentiality & Potential Risks 
This is a federally funded grant program, and as such, final research data will be publicly accessible to others 
for a minimum of 10 years on the University of Tennessee Research and Creative Exchange. Data may be used 
for future studies or shared with other researchers for use in future studies without obtaining additional 
informed consent from you or others. However, any identifiable information will not be shared or revealed. This 
means the names of your school, teachers, and students will not ever be shown to respect confidentiality. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. 
This website will not include information that can identify you. At most, the website will include a summary of 
the results. You can search this website at any time. 
 
While the breach of confidentiality of data is always a potential risk to research, I will take steps to minimize 
this. Participants and their associated data will be represented with pseudonyms or alphanumeric IDs that do 
not contain identifying information. Video data will be viewed only by researchers involved in this project. 
Further, specific information, such as names or programs, will not be disclosed in published papers or 
presentations. Data with identifying information will only be shared within the researchers. These data will be 
saved on password-protected computers and a password-protected server. Any paper documents will be 
scanned and uploaded and then immediately destroyed.  
 
Compensation 
I will offer you a $1,000 stipend for participating in 2-day professional development and $50 for each 
bi-weekly coaching session in the first year of study and another $1,000 stipend and $50 for each bi-weekly 
coaching session for your involvement in the second year of study. 
 
Discontinuing Participation 
At any time, you may request to withdraw your consent or discontinue participation. Your requests will be 
honored promptly and unconditionally without penalty, and any data collected from you will be immediately 
 

 
destroyed. Stipends will be prorated.   
 
Questions 
If you have any questions about this study, please contact Leala Holcomb, Principal Investigator, email: 
lholcom5@utk.edu. If you have any questions or concerns regarding your rights as a study participant, or if 
you are dissatisfied at any time with any aspect of this  study, you may contact the UT Office of Research 
IRB Compliance Officer at (865) 974-7697 or at utkirb@utk.edu.  
 
Sincerely,  
 
Leala Holcomb, Ph.D.  
University of Tennessee 
 
 
Your name (please print): _________________________________________________  
 
 
 
Your signature below indicates your consent to participate in this study. 
 
 
Signature: __________________________________________  Date: ____________  
 
 
 
 
Your signature below indicates your consent to have your classroom video footage shown in future professional 
development given to other teachers (optional). 
 
 
Signature: __________________________________________  Date: ____________  
​