NCT06722261

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Aug 2025Nov 2026

First Submitted

Initial submission to the registry

December 5, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

November 24, 2025

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

December 5, 2024

Last Update Submit

November 21, 2025

Conditions

Keywords

Sign LanguageDeafIntervention

Outcome Measures

Primary Outcomes (1)

  • Sign Language Skills

    Deaf children's development of target sign language skills will be documented.

    From enrollment to the end of treatment 9 academic months later.

Study Arms (4)

Single Case Research Design: Phase 1

EXPERIMENTAL

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.

Behavioral: Strategic and Interactive Signing Instruction

Single Case Research Design: Phase 2

EXPERIMENTAL

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.

Behavioral: Strategic and Interactive Signing Instruction

Single Case Research Design: Phase 3

EXPERIMENTAL

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.

Behavioral: Strategic and Interactive Signing Instruction

Single Case Research Design: Phase 4

EXPERIMENTAL

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.

Behavioral: Strategic and Interactive Signing Instruction

Interventions

Evidence-based instructional methods, grounded in cognitive, sociocultural, and linguistic theories, are applied to interventions that support sign language development in deaf children.

Single Case Research Design: Phase 1Single Case Research Design: Phase 2Single Case Research Design: Phase 3Single Case Research Design: Phase 4

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Deaf children in kindergarten to 3rd grade class in a school for the deaf

You may not qualify if:

  • Non-deaf children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee, Knoxville

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

Sign Language

Condition Hierarchy (Ancestors)

LanguageCommunicationBehaviorManual CommunicationNonverbal Communication

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 9, 2024

Study Start

August 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

November 24, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, CSR, ANALYTIC CODE
Time Frame
December, 2026 to December, 2036
Access Criteria
Researchers may contact the principal investigator for additional supporting information not available on OSF.

Locations