NCT06729164

Brief Summary

This RCT study involves teachers divided into an experimental group and a control group. Teachers in the experimental group will receive SISI training to support the sign language development of deaf children, while those in the control group will continue with "business-as-usual" teaching methods. Pre- and post-assessments will be conducted for all deaf children at the beginning and end of the school year.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Apr 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 Progress83%
Apr 2025Jul 2026

First Submitted

Initial submission to the registry

December 5, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

November 24, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

December 5, 2024

Last Update Submit

November 18, 2025

Conditions

Keywords

DeafSign languageInstructionIntervention

Outcome Measures

Primary Outcomes (2)

  • Sign Language Skills

    Student data will be analyzed using rubrics adapted from the National Assessment of Educational Progress (NAEP) standardized writing assessments.

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

  • Teacher Practice

    The SISI Fidelity Tool, grounded in existing literature on evidence-based instructional methods, will be used to evaluate teachers' instructional practices.

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

Secondary Outcomes (1)

  • Written Language Skills

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

Study Arms (2)

RCT - Experimental

EXPERIMENTAL

This RCT study involves teachers divided into an experimental group and a control group. Teachers in the experimental group will receive SISI training to support the sign language development of deaf children, while those in the control group will continue with "business-as-usual" teaching methods. Pre- and post-assessments will be conducted for all deaf children at the beginning and end of the school year.

Behavioral: Strategic and Interactive Signing Instruction

Quasi-Experimental Study - Control

PLACEBO COMPARATOR

This quasi-experimental study involves teachers divided into an experimental group and a control group. Teachers in the experimental group will receive SISI training to support the sign language development of deaf children, while those in the control group will continue with "business-as-usual" teaching methods. Pre- and post-assessments will be conducted for all deaf children at the beginning and end of the school year.

Behavioral: Business-As-Usual Instruction

Interventions

Evidence-based instructional methods guided by cognitive, sociocultural, and linguistic theories that are applied to interventions supporting sign language development among deaf children.

RCT - Experimental

Teachers will teach business-as-usual without the inclusion of SISI.

Quasi-Experimental Study - Control

Eligibility Criteria

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

You may qualify if:

  • Deaf children in educational programs (aged 4-12)
  • Teachers of the deaf working with deaf children

You may not qualify if:

  • Non-deaf children
  • Non teachers of the deaf

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee, Knoxville

Knoxville, Tennessee, 37996, United States

Location

Related Publications (2)

  • Holcomb L, Eberwein AA. Teacher reports of ASL literacy instruction in deaf education. J Deaf Stud Deaf Educ. 2025 Oct 7:enaf060. doi: 10.1093/jdsade/enaf060. Online ahead of print.

    PMID: 41055392BACKGROUND
  • Holcomb L. Exploring signed literacy in elementary deaf students through evidence-based instructional methods. Sign Language Studies. 2024; 24(4):843-882.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Sign Language

Condition Hierarchy (Ancestors)

LanguageCommunicationBehaviorManual CommunicationNonverbal Communication

Study Officials

  • Leala Holcomb, PhD

    Center of Deafness

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 11, 2024

Study Start

April 1, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

November 24, 2025

Record last verified: 2025-09

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, SAP, ICF, 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.

Available IPD Datasets

The study's relevant instructional context measures. Supporting materials include the assessment instrument, protocols, etc. (Open Science Framework)Access

Locations