NCT06667102

Brief Summary

Strategic and interactive approaches driven by sociocultural, cognitive, and language theories have accumulated a large body of evidence documenting improvements in more complex oral and written language skills. Growing evidence demonstrates that more complex sign language skills positively predict literacy skills and may lead to improved health outcomes. This project involves new applications of theory-driven strategic and interactive approaches in an intervention program to target sign language development in deaf children between 5 and 8 years old who are at high risk of language delays.

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
8mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Aug 2024Dec 2026

Study Start

First participant enrolled

August 23, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

1.9 years

First QC Date

October 29, 2024

Last Update Submit

October 29, 2024

Conditions

Keywords

Sign languageTeacher trainingLanguage deprivation

Outcome Measures

Primary Outcomes (2)

  • Sign Language Skills

    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

    Teachers' fidelity to SISI will be measured through the fidelity instrument.

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

Secondary Outcomes (1)

  • Written Language

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

Study Arms (4)

Improving Teacher Fidelity to SISI

EXPERIMENTAL

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.

Behavioral: Strategic and Interactive Signing Instruction

Control and Experimental Groups: SISI Efficacy

EXPERIMENTAL

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.

Behavioral: Strategic and Interactive Signing Instruction

Pre- and Post- Descriptive Study Data of Language Outcomes Children

EXPERIMENTAL

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.

Behavioral: Strategic and Interactive Signing Instruction

Single Case Research Design: Deaf Children's Language Growth

EXPERIMENTAL

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.

Behavioral: Strategic and Interactive Signing Instruction

Interventions

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.

Control and Experimental Groups: SISI EfficacyImproving Teacher Fidelity to SISIPre- and Post- Descriptive Study Data of Language Outcomes ChildrenSingle Case Research Design: Deaf Children's Language Growth

Eligibility Criteria

Age4 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Deaf students in prekindergarten to 3rd grade classes
  • Teachers of the deaf in prekindergarten to 3rd grade classes

You may not qualify if:

  • 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

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
PREVENTION
Intervention Model
CROSSOVER
Model Details: The PI will implement an experimental single case research design to track doses of SISI training and its efficacy in increasing teacher faithfulness to SISI. The PI will implement an experimental single case research design to identify causal relations between SISI and target sign language skills. The PI will implement a pre- and post- data to track deaf children's baseline growth in sign language skills prior to receiving SISI. The PI will implement a quasi-experimental study to identify the efficacy of SISI in improving deaf children's sign language skills.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2024

First Posted

October 31, 2024

Study Start

August 23, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

October 31, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

The data from interventions in all four arms (two single case research designs and two baseline / quasi-experimental designs) will be shared in .csv files.

Shared Documents
CSR
Time Frame
IPD will be made available on 12/30/2026 with no end date.
Access Criteria
A researcher may access the IPD by contacting the principal investigator.

Locations