Hearing Loss, BilateralTALINCT04857255
Technology-assisted Language Intervention (TALI)
A study testing Technology assisted language intervention and Treatment as usual in people with Hearing Loss, Bilateral and Language Development, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial summary
This study is testing the effectiveness of augmentative and alternative communication technology among deaf or hard of hearing children for improving language development. Children will be randomized to receive either the technology intervention or treatment as usual Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Bilateral, Language Development
- What is being tested?
- Technology assisted language intervention and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2020to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 3-10 years
- Documented permanent bilateral hearing loss with severity levels clinically defined moderate to profound).
- Identified with a language deficit, defined by either the ratio of language standard scores to nonverbal intelligence quotient <.85 or a differences in nonverbal IQ and language standard scores of 10 points. Language scores may either be receptive or expressive.
- Currently receiving speech-language therapy.
Who cannot join
- Mild hearing loss and unilateral hearing loss
- primary language other than English
- significant motor impairments
- nonverbal IQ <80
- children with severe communication disorders (i.e. autism spectrum disorders).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Colorado
Aurora, Colorado, 80045
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Technology-assisted Language Intervention for Children Who Are Deaf/Hard-of-hearing (TALI)
This study is testing the effectiveness of augmentative and alternative communication technology among deaf or hard of hearing children for improving language development. Children will be randomized to receive either the technology intervention or treatment as usual
- Conditions
- Hearing Loss, Bilateral, Language Development
- Being tested
- Technology assisted language intervention, Treatment as usual
- Keywords
- hearing loss, randomized clinical trial, intervention, language development
- Medical subject headings
- Hearing Loss, Bilateral, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology assisted language interventionBehavioural
speech language therapy that has integrated technology delivered through specific software on an iPad
Treatment as usualBehavioural
No change will occur to the current ongoing speech-language therapy being delivered.
| Study group | Role | What they receive |
|---|---|---|
| Technology Assisted Language Intervention (TALI) | Active comparator | Augmentative and alternative communication software incorporated into active speech-language therapy Receives: Behavioral: Technology assisted language intervention |
| Treatment as Usual | Active comparator | Speech language therapy child is typically receiving (no change to current care) Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Length of Utterance in morphemes
Measurement of syntax
Measured: 24 weeks
Mean Turn Length
Measurement of discourse
Measured: 24 weeks
Number of different vocabulary words spoken
measure of semantics
Measured: 24 weeks
Clinical Evaluation of Language Fundamentals-5th edition
Provides receptive and expressive standard scores on a scale with a mean of 100 +/- 15standard deviations; higher scores indicate better/higher language skills
Measured: 24 weeks
Secondary outcomes (2)
Expressive Vocabulary Test 2nd edition
Provides expressive vocabulary standard scores on a scale with a mean of 100 +/- 15standard deviations; higher scores indicate better/higher vocabulary skills
Measured: 24 weeks
Clinical Evaluation of Language Fundamentals-5th edition-pragmatics profile
Provides pragmatic language scores as scaled scores (ranging from 1 to 15), age equivalents and percentile ranks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start15 Oct 2020
- Primary completion26 Dec 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, BilateralStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jareen Meinzen-Derr, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857255
- Sponsor's protocol ID
- R01DC018550
- Acronym
- TALI
- Status last verified
- Jul 2026
- First submitted
- 19 Apr 2021
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-assisted Language Intervention for Children Who Are Deaf/Hard-of-hearing (TALI)
- ClinicalTrials.gov ID
- NCT04857255
- Acronym / sponsor ID
- TALI / R01DC018550
- Conditions
- Hearing Loss, Bilateral, Language Development
- Keywords
- hearing loss, randomized clinical trial, intervention, language development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 26 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 23 Apr 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 is testing the effectiveness of augmentative and alternative communication technology among deaf or hard of hearing children for improving language development. Children will be randomized to receive either the technology intervention or treatment as usual
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology Assisted Language Intervention (TALI) | Active comparator | Behavioral: Technology assisted language interventionAugmentative and alternative communication software incorporated into active speech-language therapy |
| Treatment as Usual | Active comparator | Behavioral: Treatment as usualSpeech language therapy child is typically receiving (no change to current care) |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 3-10 years
- Documented permanent bilateral hearing loss with severity levels clinically defined moderate to profound).
- Identified with a language deficit, defined by either the ratio of language standard scores to nonverbal intelligence quotient <.85 or a differences in nonverbal IQ and language standard scores of 10 points. Language scores may either be receptive or expressive.
- Currently receiving speech-language therapy.
Key exclusion criteria (5 listed)
- Mild hearing loss and unilateral hearing loss
- primary language other than English
- significant motor impairments
- nonverbal IQ <80
- children with severe communication disorders (i.e. autism spectrum disorders).
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 |
|---|---|---|
| Technology assisted language interventionspeech language therapy that has integrated technology delivered through specific software on an iPad | Behavioural | Technology Assisted Language Intervention (TALI) |
| Treatment as usualNo change will occur to the current ongoing speech-language therapy being delivered. | Behavioural | Treatment as Usual |
Primary outcome
Mean Length of Utterance in morphemes
Time frame: 24 weeks
Measurement of syntax
Mean Turn Length
Time frame: 24 weeks
Measurement of discourse
Number of different vocabulary words spoken
Time frame: 24 weeks
measure of semantics
Clinical Evaluation of Language Fundamentals-5th edition
Time frame: 24 weeks
Provides receptive and expressive standard scores on a scale with a mean of 100 +/- 15standard deviations; higher scores indicate better/higher language skills
2 secondary outcomes
Expressive Vocabulary Test 2nd edition
Time frame: 24 weeks
Clinical Evaluation of Language Fundamentals-5th edition-pragmatics profile
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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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.
Jareen Meinzen-Derr principal investigator
Children's Hospital Medical Center, Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology assisted language intervention and Treatment as usual in people with Hearing Loss, Bilateral and Language Development, run by Children's Hospital Medical Center, Cincinnati at 2 sites 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean Length of Utterance in morphemes (time frame: 24 weeks). The study lists 4 primary outcomes in all. 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 30 Jul 2026.