- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04988451
Family ASL: Longitudinal Study of Deaf Children and Hearing Parents Who Receive Services to Support the Learning of ASL (FASL)
July 19, 2023 updated by: Diane Lillo-Martin, University of Connecticut
Family ASL: Longitudinal Study of Deaf Children and Hearing Parents Who Receive Services to Support the Learning of American Sign Language (ASL)
This study examines the development of American Sign Language by deaf and hard of hearing (DHH) children and their parents.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
40
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 Contact
- Name: Diane C Lillo-Martin, Ph.D.
- Phone Number: 860-486-0155
- Email: diane.lillo-martin@uconn.edu
Study Locations
-
-
Connecticut
-
Storrs, Connecticut, United States, 06268
- Recruiting
- University of Connecticut - Department of Linguistics
-
Contact:
- Diane C Lillo-Martin, Ph.D.
- Phone Number: 860-455-5174
- Email: diane.lillo-martin@uconn.edu
-
-
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
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ASL Services - Adult ASL Development
Presence (or absence, across 6-week periods) of ASL services designed to support improvement in ASL fluency
|
ASL specialist meets with participants and provides ASL instruction
|
Experimental: ASL Services - Child Language Development
Presence (or absence, across 6-week periods) of ASL services designed to support improvement in ASL fluency
|
ASL specialist meets with participants and provides ASL instruction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in ASL Phonological Production Accuracy over 12 Months
Time Frame: Baseline and 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in ASL Production Frequency over 12 Months
Time Frame: Baseline and 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Diane C Lillo-Martin, Ph.D., University of Connecticut
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)
July 20, 2021
Primary Completion (Estimated)
March 31, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
July 26, 2021
First Submitted That Met QC Criteria
July 26, 2021
First Posted (Actual)
August 3, 2021
Study Record Updates
Last Update Posted (Actual)
July 20, 2023
Last Update Submitted That Met QC Criteria
July 19, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H20-0037
- R01DC016901 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified data from language tasks
IPD Sharing Time Frame
After (or with) publication of the results
IPD Sharing Access Criteria
De-identified numerical coding scores will be shared using an open science site that is generally accessible
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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