Clinical trial NCT06667102: Strategic and Interactive Signing Instruction
Official title: Strategic and Interactive Signing Instruction (SISI): An Intervention Program to Support Sign Language Development in Deaf Children
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Teaching Behaviors
Sign Language Skills
Keywords: Sign language
Teacher training
Language deprivation
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2024-10-31
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: Deaf children who reach the age of eight without a foundation in language have longitudinal struggles in the areas of receptive and expressive language, working memory, executive functions, literacy and academic skills, and behavioral, mental, social, and physical health. The lack of intervention programs targeting sign language competencies during the critical period of development is a critical barrier to making progress in preventing or addressing language delays in deaf children. 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. Cross-linguistic transfers between oral and writing skills within and across first and second languages are well-established in the literature. Taking these factors into account in addition to growing evidence that sign language skills positively predict literacy skills and may lead to improved health outcomes, it is critical to systematically support deaf children's sign language competences as early as possible. To address the identified critical barrier to progress, these are the aims of this project: (1) develop Strategic and Interactive Signing Instruction (SISI), an intervention program to target the development of sign language skills in deaf children aged 5-8; (2) refine SISI training and implementation protocols; and (3) test the efficacy of SISI in improving deaf children's sign language skills. First, a SISI manual will be developed for standardization and consistency in training, implementation, and fidelity. The SISI manual will include: (a) descriptions of strategic and interactive approaches and their new applications to develop sign language skills, (b) SISI intervention protocols, (c) SISI fidelity checklist, and (d) list of sign language skills that are targeted in SISI. Second, an experimental study will be conducted to assess the extent of training and support required from teachers to become proficient in SISI implementation. Meanwhile, child progress in meeting their target sign language skills will be monitored formatively, and modifications may be made in an iterative design fashion to strengthen the intervention design. Third, another experimental study will be applied to assess the efficacy of SISI in improving deaf children's sign language skills. Findings will provide robust data on the mechanisms of successful training dose, intervention design and fidelity, and data collection protocols in preparation for subsequent R01 application involving a large randomized controlled trial with sufficient statistical power to further strengthen evidence of SISI in improving deaf children's sign language skills along with examinations of cross-linguistic interactions in the written form. This project is innovative in its new applications of theory-driven strategic and interactive approaches to target sign language development in deaf children.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sign Language Skills
timeFrame: From enrollment to the end of treatment 9 academic months later.
measure: Teaching Behaviors
timeFrame: From enrollment to the end of treatment 9 academic months later.
Secondary outcomes:
measure: Written Language
timeFrame: From enrollment to the end of treatment 9 academic months later.
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee, Knoxville
state: Tennessee
Study officials:
References: