[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06667102":3,"trial-entities:NCT06667102":80,"trial-summary:NCT06667102":85},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":41,"secondary_outcomes":47,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":62,"locations":66,"central_contacts":76,"overall_officials":77,"references":78,"see_also_links":79},"NCT06667102","UTennesseeKnoxville","Strategic and Interactive Signing Instruction","Strategic and Interactive Signing Instruction (SISI): An Intervention Program to Support Sign Language Development in Deaf Children","ENROLLING_BY_INVITATION","2026-12-30","2024-10","2024-10-31","2024-08-23","The University of Tennessee, Knoxville","OTHER",false,"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.","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.",[19,20],"Teaching Behaviors","Sign Language Skills",[22,23,24],"Sign language","Teacher training","Language deprivation","INTERVENTIONAL","PREVENTION",[28],"NA",{"count":30,"type":31},150,"ESTIMATED",[33],{"type":34,"name":6,"description":35,"armGroupLabels":36},"BEHAVIORAL","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.",[37,38,39,40],"Control and Experimental Groups: SISI Efficacy","Improving Teacher Fidelity to SISI","Pre- and Post- Descriptive Study Data of Language Outcomes Children","Single Case Research Design: Deaf Children's Language Growth",[42,45],{"measure":20,"description":43,"timeFrame":44},"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.",{"measure":19,"description":46,"timeFrame":44},"Teachers' fidelity to SISI will be measured through the fidelity instrument.",[48],{"measure":49,"description":50,"timeFrame":44},"Written Language","Deaf children's application of genre-based trait skills in written language will be analyzed using the emergent writing stages and rubrics adapted from the National Assessment of Educational Progress (NAEP) rubrics for standardized writing assessments.","ALL","4 Years","99 Years",{"inclusion":55,"exclusion":58,"raw_text":61},[56,57],"Deaf students in prekindergarten to 3rd grade classes","Teachers of the deaf in prekindergarten to 3rd grade classes",[59,60],"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","Inclusion Criteria:\n\n* Deaf students in prekindergarten to 3rd grade classes\n* Teachers of the deaf in prekindergarten to 3rd grade classes\n\nExclusion Criteria:\n\n* Hearing students, deaf students aged 0-3 or 4th grade and beyond\n* Non-teachers of the deaf or teachers of the deaf in 4th grade and beyond",[63,64,65],"CHILD","ADULT","OLDER_ADULT",[67],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"geoPoint":73},"University of Tennessee, Knoxville","Knoxville","Tennessee","37996","United States",{"lat":74,"lon":75},35.96064,-83.92074,[],[],[],[],{"nct_id":4,"conditions":81,"biomarkers":84},[82,83],"Deafness","Language Delay",[],{"nct_id":4,"found":15,"summary":86,"prompt_version":86},null]