- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06722261
Single Case Research Design: Deaf Children's Language Outcomes
November 21, 2025 updated by: The University of Tennessee, Knoxville
Eight deaf children in kindergarten to 3rd grade classes will be randomly selected for single case research.
Their language skills will be monitored and assessed daily.
Using a noncurrent multiple baseline design (Single Case Research Design or SCRD), Strategic and Interactive Signing Instruction (SISI) will be administered to two children in each of four classes.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
A randomized selection method will be employed to select deaf children to participate in single case research.
Two children will be selected from each age group between 5 and 10, making a total of eight students.
Their language skills will be closely monitored and evaluated over the course of the year.
Following the noncurrent multiple baseline design, in succession across 8 child participants in 4 classes, 2 SCRD participants in a class will begin receiving SISI while other children remain in the baseline for 3 weeks.
Brainstorming occurs on Monday and the final sign language composition is shared on Friday.
At the end of each day's intervention, child participants will independently narrate their expressed message recorded on videos.
A score of 1 (applied correctly), 0.5 (applied but incorrectly), or 0 (omitted) will be given to their inclusion of target sign language skills, which is converted into percentages.
If a child receives 100% on their target SL skill for 3 consecutive days (3 data points), Teacher 1 will select a new sign language skill to target.
If the child receives 0% or 50% on their target sign language skill, Teacher 1 continues to focus on the same sign language skill.
Study Type
Interventional
Enrollment (Estimated)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37996
- University of Tennessee, Knoxville
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Deaf children in kindergarten to 3rd grade class in a school for the deaf
Exclusion Criteria:
- Non-deaf children
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single Case Research Design: Phase 3
A randomized selection method will be employed to select deaf children to participate in single case research.
Two children will be selected from each age group between 5 and 10, making a total of eight students.
Their language skills will be closely monitored and evaluated over the course of the year.
Following the noncurrent multiple baseline design, in succession across 8 child participants in 4 classes, 2 SCRD participants in a class will begin receiving SISI while other children remain in the baseline for 3 weeks.
|
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: Phase 4
A randomized selection method will be employed to select deaf children to participate in single case research.
Two children will be selected from each age group between 5 and 10, making a total of eight students.
Their language skills will be closely monitored and evaluated over the course of the year.
Following the noncurrent multiple baseline design, in succession across 8 child participants in 4 classes, 2 SCRD participants in a class will begin receiving SISI while other children remain in the baseline for 3 weeks.
|
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: Phase 1
A randomized selection method will be employed to select deaf children to participate in single case research.
Two children will be selected from each age group between 5 and 10, making a total of eight students.
Their language skills will be closely monitored and evaluated over the course of the year.
Following the noncurrent multiple baseline design, in succession across 8 child participants in 4 classes, 2 Phase 1 participants in a class will begin receiving SISI while other children remain in the baseline for 3 to 9 weeks.
|
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: Phase 2
A randomized selection method will be employed to select deaf children to participate in single case research.
Two children will be selected from each age group between 5 and 10, making a total of eight students.
Their language skills will be closely monitored and evaluated over the course of the year.
Following the noncurrent multiple baseline design, in succession across 8 child participants in 4 classes, three weeks after Phase 1 participants have begun SISI, Phase 2 participants in a class will begin receiving SISI while other children remain in the baseline.
|
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 |
|---|---|---|
|
Sign Language Skills
Time Frame: From enrollment to the end of treatment 9 academic months later.
|
Deaf children's development of target sign language skills will be documented.
|
From enrollment to the end of treatment 9 academic months later.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2025
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
November 30, 2026
Study Registration Dates
First Submitted
December 5, 2024
First Submitted That Met QC Criteria
December 5, 2024
First Posted (Actual)
December 9, 2024
Study Record Updates
Last Update Posted (Actual)
November 24, 2025
Last Update Submitted That Met QC Criteria
November 21, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 478857
- R21DC021024 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
December, 2026 to December, 2036
IPD Sharing Access Criteria
Researchers may contact the principal investigator for additional supporting information not available on OSF.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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