DeafnessFASLNCT04988451
Family ASL: Longitudinal Study of Deaf Children and Hearing Parents Who Receive Services to Support the Learning of ASL
A study testing ASL Services in people with Deafness and Hearing Loss, run by University of Connecticut at 1 site in United States.
Trial summary
This study examines the development of American Sign Language by deaf and hard of hearing (DHH) children and their parents. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Deafness, Hearing Loss
- What is being tested?
- ASL Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2021to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut - Department of Linguistics
Storrs, Connecticut, 06268
About this study
Official title: 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.
Read the 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.
- Conditions
- Deafness, Hearing Loss
- Being tested
- ASL Services
- Keywords
- language, sign language, language development, child language, child, preschool, parents, caregivers
- Medical subject headings
- Deafness, Hearing Loss, Language, Sign Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASL ServicesBehavioural
ASL specialist meets with participants and provides ASL instruction
| Study group | Role | What they receive |
|---|---|---|
| ASL Services - Adult ASL Development | Experimental | Presence (or absence, across 6-week periods) of ASL services designed to support improvement in ASL fluency Receives: 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 Receives: Behavioral: ASL Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
Secondary outcomes (1)
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.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start20 Jul 2021
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Diane Lillo-Martin, University of Connecticut
- Investigators
- Diane C Lillo-Martin, Ph.D., Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988451
- Sponsor's protocol ID
- H20-0037
- Other IDs
- R01DC016901
- Acronym
- FASL
- Status last verified
- Jul 2025
- First submitted
- 26 Jul 2021
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from language tasks
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family ASL: Longitudinal Study of Deaf Children and Hearing Parents Who Receive Services to Support the Learning of American Sign Language (ASL)
- ClinicalTrials.gov ID
- NCT04988451
- Acronym / sponsor ID
- FASL / H20-0037
- Conditions
- Deafness, Hearing Loss
- Keywords
- language, sign language, language development, child language, child, preschool, parents, caregivers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| ASL Services - Adult ASL Development | Experimental | Behavioral: ASL ServicesPresence (or absence, across 6-week periods) of ASL services designed to support improvement in ASL fluency |
| ASL Services - Child Language Development | Experimental | Behavioral: ASL ServicesPresence (or absence, across 6-week periods) of ASL services designed to support improvement in ASL fluency |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- One adult caregiver for each child
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASL ServicesASL specialist meets with participants and provides ASL instruction | Behavioural | ASL Services - Adult ASL Development, ASL Services - Child Language Development |
Primary outcome
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.
1 secondary outcome
Change from Baseline in ASL Production Frequency over 12 Months
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified data from language tasks
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane C Lillo-Martin, Ph.D. principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASL Services in people with Deafness and Hearing Loss, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in ASL Phonological Production Accuracy over 12 Months (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.