- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06667102
Strategic and Interactive Signing Instruction (SISI)
Strategic and Interactive Signing Instruction (SISI): An Intervention Program to Support Sign Language Development in Deaf Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Deaf students in prekindergarten to 3rd grade classes
- Teachers of the deaf in prekindergarten to 3rd grade classes
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Improving Teacher Fidelity to SISI
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.
|
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.
|
|
Experimental: Control and Experimental Groups: SISI Efficacy
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. |
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.
|
|
Experimental: Pre- and Post- Descriptive Study Data of Language Outcomes Children
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.
|
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.
|
|
Experimental: Single Case Research Design: Deaf Children's Language Growth
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to the end of treatment 9 academic months later.
|
|
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.
|
From enrollment to the end of treatment 9 academic months later.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Written Language
Time Frame: From enrollment to the end of treatment 9 academic months later.
|
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.
|
From enrollment to the end of treatment 9 academic months later.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- UTennesseeKnoxville
- R21DC021024 (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
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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