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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04988451
Other study ID # H20-0037
Secondary ID R01DC016901
Status Recruiting
Phase N/A
First received
Last updated
Start date July 20, 2021
Est. completion date June 30, 2024

Study information

Verified date July 2023
Source University of Connecticut
Contact Diane C Lillo-Martin, Ph.D.
Phone 860-486-0155
Email diane.lillo-martin@uconn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study examines the development of American Sign Language by deaf and hard of hearing (DHH) children and their parents.


Description:

After being informed about the study and potential risks, adult participants who give written informed consent and children whose parents who give written permission will be enrolled in the study. They will participate in preliminary language tasks to assess baseline performance on American Sign Language (ASL) measures. Subsequently they will have weekly sessions with an ASL Specialist to support their development of ASL, following a 6-week on/6-week off ABABABAB sequence.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 30, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility Inclusion Criteria: Children: - Children ages 2;00 - 2;11 at the start of the longitudinal project - Child is Deaf/ Hard-of-Hearing - Participating in a program utilizing a bimodal bilingual philosophy Adults: - One adult caregiver for each child Exclusion Criteria: - Children with previously-diagnosed conditions other than deafness known to affect language and cognitive development - Families without access to internet (at home or other locations)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
ASL Services
ASL specialist meets with participants and provides ASL instruction

Locations

Country Name City State
United States University of Connecticut - Department of Linguistics Storrs Connecticut

Sponsors (2)

Lead Sponsor Collaborator
University of Connecticut National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in ASL Phonological Production Accuracy over 12 Months Participants copy ASL signs produced on video; their productions are scored for phonological accuracy and reported as percent correct out of all possible phonological features. Weekly measures are taken for SCD analysis. Baseline and 12 months
Secondary Change from Baseline in ASL Production Frequency over 12 Months Participants engage in naturalistic play sessions which are videorecorded. Sessions are analyzed for the number of productions in ASL over a 15-minute period. Weekly measures are taken for SCD analysis. Baseline and 12 months
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