NCT04988451

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

4.4 years

First QC Date

July 26, 2021

Last Update Submit

July 8, 2025

Conditions

Keywords

languagesign languagelanguage developmentchild languagechild, preschoolparentscaregivers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change from Baseline in ASL Production Frequency over 12 Months

    Baseline and 12 months

Study Arms (2)

ASL Services - Adult ASL Development

EXPERIMENTAL

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

Behavioral: ASL Services

ASL Services - Child Language Development

EXPERIMENTAL

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

Behavioral: ASL Services

Interventions

ASL ServicesBEHAVIORAL

ASL specialist meets with participants and provides ASL instruction

ASL Services - Adult ASL DevelopmentASL Services - Child Language Development

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut - Department of Linguistics

Storrs, Connecticut, 06268, United States

Location

MeSH Terms

Conditions

DeafnessHearing LossLanguageSign Language

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCommunicationBehaviorManual CommunicationNonverbal Communication

Study Officials

  • Diane C Lillo-Martin, Ph.D.

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BOT Distinguished Professor

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 3, 2021

Study Start

July 20, 2021

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

De-identified data from language tasks

Time Frame
After (or with) publication of the results
Access Criteria
De-identified numerical coding scores will be shared using an open science site that is generally accessible

Locations