Hearing LossNCT02998164
Improving Outcomes Using Technology for Children Who Are DHH
A study testing augmentative and alternative communication technology in people with Hearing Loss and Language Development, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial summary
This study evaluates the efficacy of using augmentative and alternative communication (AAC) technology for enhancing language development in children who are deaf or hard of hearing. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Hearing Loss, Language Development, Social Behavior
- What is being tested?
- augmentative and alternative communication technology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2016to Dec 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- documented permanent bilateral hearing loss with severity levels clinically defined in any range (mild to profound);
- identified with a language gap;
- currently receiving speech-language therapy.
Who cannot join
- primary language other than English
- significant motor impairments
- nonverbal IQ <60
- 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: Improving Outcomes Using Augmentative and Alternative Communication for Children Who Are Deaf or Hard of Hearing
This study evaluates the efficacy of using augmentative and alternative communication (AAC) technology for enhancing language development in children who are deaf or hard of hearing. Half of the participants will receive AAC technology with their speech and language therapy and half will continue with their usual care models.
- Conditions
- Hearing Loss, Language Development, Social Behavior
- Being tested
- augmentative and alternative communication technology, Usual Care
- Medical subject headings
- Hearing Loss, Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
augmentative and alternative communication technologyBehavioural
Usual CareBehavioural
No change to the therapy care received
| Study group | Role | What they receive |
|---|---|---|
| Technology-assisted language intervention | Experimental | This intervention will incorporate augmentative and alternative communication software delivered on iPads into speech-language therapy Receives: Behavioral: augmentative and alternative communication technology |
| usual care | Active comparator | This group will be usual care children are already receiving. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Syntax
Evaluated using the mean length of utterance in morphemes collected from language samples. Assessing change between baseline and 24 weeks.
Measured: Change between baseline and 24 weeks
semantics
Variety and total number of vocabulary words used collected from language samples.Assessing change between baseline and 24 weeks.
Measured: Change between baseline and 24 weeks
Discourse
Child's mean turn length in words collected from language samples. Assessing change between baseline and 24 weeks.
Measured: Assessing change between baseline and 24 weeks.
Secondary outcomes (2)
Language standard scores (receptive and expressive)
Receptive language (what a child understands) and expressive language (what a child says) as measured by standardized language assessment.
Measured: Assessing change between baseline and 24 weeks.
Social functioning
Social functioning as measured by parent-reported assessments or scales
Measured: Assessing change between baseline and 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies 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
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Jareen Meinzen-Derr, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998164
- Sponsor's protocol ID
- CIN001-Improving Outcomes
- Status last verified
- Dec 2025
- First submitted
- 10 Nov 2016
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We currently do not have a IPD sharing plan. However, we will have one in place prior to the end of the study
Publications
Betances E, Wiley S, Tabangin M, Sheldon R, Lane L, Mood D, Williams-Arya P, Schumacher J, Meinzen-Derr J. Preliteracy Skills in Young Children Who are Deaf/Hard of Hearing: Secondary Analysis of the Technology-assisted Language Intervention Randomized Trials. J Dev Behav Pediatr. 2025 Nov-Dec 01;46(6):e592-e598. doi: 10.1097/DBP.0000000000001394. Epub 2025 Jul 17.
PubMed 40700591Mood D, Sheldon R, Tabangin M, Wiley S, Meinzen-Derr J. Technology assisted language intervention (TALI) for children who are deaf/hard of hearing: promising impact on pragmatic skills. Deafness Educ Int. 2022;24(4):334-355. doi: 10.1080/14643154.2022.2135731. Epub 2022 Nov 1.
PubMed 37304207Meinzen-Derr J, Sheldon R, Altaye M, Lane L, Mays L, Wiley S. A Technology-Assisted Language Intervention for Children Who Are Deaf or Hard of Hearing: A Randomized Clinical Trial. Pediatrics. 2021 Feb;147(2):e2020025734. doi: 10.1542/peds.2020-025734. Epub 2021 Jan 15.
PubMed 33452063
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes Using Augmentative and Alternative Communication for Children Who Are Deaf or Hard of Hearing
- ClinicalTrials.gov ID
- NCT02998164
- Acronym / sponsor ID
- CIN001-Improving Outcomes
- Conditions
- Hearing Loss, Language Development, Social Behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- Oct 2016
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Dec 2016 (estimated)
- 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 evaluates the efficacy of using augmentative and alternative communication (AAC) technology for enhancing language development in children who are deaf or hard of hearing. Half of the participants will receive AAC technology with their speech and language therapy and half will continue with their usual care models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology-assisted language intervention | Experimental | Behavioral: augmentative and alternative communication technologyThis intervention will incorporate augmentative and alternative communication software delivered on iPads into speech-language therapy |
| usual care | Active comparator | Behavioral: Usual CareThis group will be usual care children are already receiving. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- documented permanent bilateral hearing loss with severity levels clinically defined in any range (mild to profound);
- identified with a language gap;
- currently receiving speech-language therapy.
Key exclusion criteria (4 listed)
- primary language other than English
- significant motor impairments
- nonverbal IQ <60
- 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 |
|---|---|---|
| augmentative and alternative communication technology | Behavioural | Technology-assisted language intervention |
| Usual CareNo change to the therapy care received | Behavioural | usual care |
Primary outcome
Syntax
Time frame: Change between baseline and 24 weeks
Evaluated using the mean length of utterance in morphemes collected from language samples. Assessing change between baseline and 24 weeks.
semantics
Time frame: Change between baseline and 24 weeks
Variety and total number of vocabulary words used collected from language samples.Assessing change between baseline and 24 weeks.
Discourse
Time frame: Assessing change between baseline and 24 weeks.
Child's mean turn length in words collected from language samples. Assessing change between baseline and 24 weeks.
2 secondary outcomes
Language standard scores (receptive and expressive)
Time frame: Assessing change between baseline and 24 weeks.
Social functioning
Time frame: Assessing change between baseline and 24 weeks.
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 23 Dec 2025.
- Derived from this study: PubMed 40700591Betances E, Wiley S, Tabangin M, Sheldon R, Lane L, Mood D, Williams-Arya P, Schumacher J, Meinzen-Derr J. Preliteracy Skills in Young Children Who are Deaf/Hard of Hearing: Secondary Analysis of the Technology-assisted Language Intervention Randomized Trials. J Dev Behav Pediatr. 2025 Nov-Dec 01;46(6):e592-e598. doi: 10.1097/DBP.0000000000001394. Epub 2025 Jul 17.
- Derived from this study: PubMed 37304207Mood D, Sheldon R, Tabangin M, Wiley S, Meinzen-Derr J. Technology assisted language intervention (TALI) for children who are deaf/hard of hearing: promising impact on pragmatic skills. Deafness Educ Int. 2022;24(4):334-355. doi: 10.1080/14643154.2022.2135731. Epub 2022 Nov 1.
- Derived from this study: PubMed 33452063Meinzen-Derr J, Sheldon R, Altaye M, Lane L, Mays L, Wiley S. A Technology-Assisted Language Intervention for Children Who Are Deaf or Hard of Hearing: A Randomized Clinical Trial. Pediatrics. 2021 Feb;147(2):e2020025734. doi: 10.1542/peds.2020-025734. Epub 2021 Jan 15.
- Individual participant dataSharing planned: No. We currently do not have a IPD sharing plan. However, we will have one in place prior to the end of the study
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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, PhD 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 augmentative and alternative communication technology in people with Hearing Loss 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 3 inclusion and 4 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 23 Dec 2025. 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?
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?
Syntax (time frame: Change between baseline and 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02998164, which also lists 3 linked publications.
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 23 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.