Strategic and Interactive Signing Instruction Experiment

November 18, 2025 updated by: The University of Tennessee, Knoxville

Randomized Controlled Trial: Strategic and Interactive Signing Instruction

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial (RCT) examines the effects of the Strategic and Interactive Signing Instruction (SISI) intervention on deaf children's expressive language development in signing (primary) and writing (secondary). The study compares two groups - an intervention group implementing SISI and a control group continuing their usual instructional routines without the intervention.

The intervention group will include approximately 10 teachers, each working with 5-7 deaf children. These classrooms will implement the SISI intervention, which provides structured, language-centered supports designed to strengthen children's signing through explicit modeling, guided practice, and discourse-focused intervention routines. Schools that participated in the 2024-2025 nationwide pre/post study will be included in the intervention group for 2025-2026 if they choose to continue.

The control group will likewise include approximately 10 teachers with 5-7 Deaf children each. These classrooms will continue with their standard practices without the SISI intervention. Schools newly joining the project in 2025-2026 will be assigned to this group.

Child language data will be collected twice - fall 2025 (pre-test) and spring 2026 (post-test). Deaf children will complete three expressive language prompts representing major discourse types: personal narrative, informational report, and persuasive discourse. Their signed and written compositions will be analyzed using rubrics adapted from the National Assessment of Educational Progress (NAEP), focusing on growth in discourse-level skills.

The study hypothesizes that deaf children in the intervention group will show greater gains in expressive signing and writing than their peers in the control group. This hypothesis reflects the expectation that a systematic, discourse-oriented language intervention offers stronger support for language development than typical intervention routines.

This research aims to contribute to the evidence base on interventions that support deaf children's expressive language development. By examining child-level language outcomes from a discourse-focused intervention, the study will advance understanding of how structured language support can strengthen signing and writing development for deaf children.

Study Type

Interventional

Enrollment (Estimated)

150

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

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

Exclusion Criteria:

  • Non-deaf children
  • Non teachers of the deaf

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Quasi-Experimental Study - Control
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
Teachers will teach business-as-usual without the inclusion of SISI.
Experimental: RCT - 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
Evidence-based instructional methods guided by cognitive, sociocultural, and linguistic theories that are applied to interventions supporting sign language development among 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.
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
Time Frame: From enrollment to the end of treatment 9 academic months later.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Written Language Skills
Time Frame: From enrollment to the end of treatment 9 academic months later.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Tennessee, Knoxville

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Leala Holcomb, PhD, Center of Deafness

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

April 1, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Actual)

December 11, 2024

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 451965
  • 1R21DC021024-01A1 (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
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Study Data/Documents

  1. The study's relevant instructional context measures. Supporting materials include the assessment instrument, protocols, etc.
    Information identifier: Open Science Framework

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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