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Family ASL: Longitudinal Study of Deaf Children and Hearing Parents Who Receive Services to Support the Learning of ASL (FASL)

Primary Purpose

Deafness, Hearing Loss

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ASL Services

About this trial

This is an interventional treatment trial for Deafness focused on measuring language, sign language, language development, child language, child, preschool, parents, caregivers

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of Connecticut - Department of LinguisticsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ASL Services - Adult ASL Development

ASL Services - Child Language Development

Arm Description

Presence (or absence, across 6-week periods) of ASL services designed to support improvement in ASL fluency

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04988451

First Posted

July 26, 2021

Last Updated

July 19, 2023

Sponsor

University of Connecticut

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

1. Study Identification

Unique Protocol Identification Number

NCT04988451

Brief Title

Family ASL: Longitudinal Study of Deaf Children and Hearing Parents Who Receive Services to Support the Learning of ASL

Acronym

FASL

Official Title

Family ASL: Longitudinal Study of Deaf Children and Hearing Parents Who Receive Services to Support the Learning of American Sign Language (ASL)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 20, 2021 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Connecticut

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deafness, Hearing Loss

Keywords

language, sign language, language development, child language, child, preschool, parents, caregivers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single Case Design - interrupted time series. Participants will receive intervention in 6-week on/off blocks. Measurements are taken in both on and off weeks. The Bayesian procedure developed by Swaminathan et al. (2014) involves fitting piece-wise linear or curvilinear trends across the phases, modeling dependencies in the observations with a suitably chosen autoregressive error scheme, and using the Markov Chain Monte Carlo (MCMC) method to obtain the posterior distributions of the model parameters and effect size measures

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ASL Services - Adult ASL Development

Arm Type

Experimental

Arm Description

Presence (or absence, across 6-week periods) of ASL services designed to support improvement in ASL fluency

Arm Title

ASL Services - Child Language Development

Arm Type

Experimental

Arm Description

Presence (or absence, across 6-week periods) of ASL services designed to support improvement in ASL fluency

Intervention Type

Behavioral

Intervention Name(s)

ASL Services

Intervention Description

ASL specialist meets with participants and provides ASL instruction

Primary Outcome Measure Information:

Title

Change from Baseline in ASL Phonological Production Accuracy over 12 Months

Description

Time Frame

Baseline and 12 months

Secondary Outcome Measure Information:

Title

Change from Baseline in ASL Production Frequency over 12 Months

Description

Time Frame

Baseline and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Diane C Lillo-Martin, Ph.D.

Phone

860-486-0155

diane.lillo-martin@uconn.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diane C Lillo-Martin, Ph.D.

Organizational Affiliation

University of Connecticut

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Connecticut - Department of Linguistics

City

Storrs

State/Province

Connecticut

ZIP/Postal Code

06268

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Diane C Lillo-Martin, Ph.D.

Phone

860-455-5174

diane.lillo-martin@uconn.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

Family ASL: Longitudinal Study of Deaf Children and Hearing Parents Who Receive Services to Support the Learning of ASL

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