Hearing LossNCT01963468
Maximizing Language Development in Children With Hearing Loss
A study testing Early language intervention in people with Hearing Loss, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of early intervention on language skills for children with hearing loss. Read more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Early language intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2016
- 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 6 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6 to 18 months of age
- bilateral, moderate to profound congenital hearing loss
Who cannot join
- auditory neuropathy
- no known additional disabilities (e.g., cerebral palsy, Down syndrome)
- both parents have a severe to profound hearing loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-Implantation Communication Treatment for Children With Hearing Loss
The purpose of this study is to evaluate the effects of early intervention on language skills for children with hearing loss.
- Conditions
- Hearing Loss
- Being tested
- Early language intervention
- Keywords
- Hearing Loss, Cochlear Implant, Deaf, Hearing Impairment, Hard of Hearing
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early language interventionBehavioural
Parents will practice the specific set of strategies (visual, interactive, tactile, responsive) during sessions that occur weekly and last 1 hour for a total of 26 sessions, over 6 months. Each session will include four segments: (a) the therapist will review the intervention strategies taught in the workshop (10 min), (b) the therapist will model the intervention strategy with the child (10 min), (c) the parent will practice the strategy with her child with coaching from the therapist across four different routines and activities of the parent's choice (30 min), and (d) the therapist will provide feedback to the parent, summarize the session, and answer the parent's questions (10 min).
| Study group | Role | What they receive |
|---|---|---|
| Early language intervention | Experimental | Children will receive 6 months of weekly parent-implemented intervention sessions.
Children will be assessed monthly via audio recordings and language checklists to monitor language development more closely. Receives: Behavioral: Early language intervention |
| Monthly language check-ups | No intervention | Children will be assessed monthly via home observations and parents will complete a language checklist to monitor language development more closely. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MacArthur Communicative Development Inventories
Measured: one month
Secondary outcomes (1)
Preschool Language Scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Megan Roberts, Northwestern University
- Investigators
- Megan Y Roberts, PhD, CCC-SLP, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963468
- Sponsor's protocol ID
- STU00081066
- Other IDs
- 1R03DC012639
- Status last verified
- Mar 2018
- First submitted
- 11 Oct 2013
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Implantation Communication Treatment for Children With Hearing Loss
- ClinicalTrials.gov ID
- NCT01963468
- Acronym / sponsor ID
- STU00081066
- Conditions
- Hearing Loss
- Keywords
- Hearing Loss, Cochlear Implant, Deaf, Hearing Impairment, Hard of Hearing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Oct 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Oct 2013 (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.
The purpose of this study is to evaluate the effects of early intervention on language skills for children with hearing loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early language intervention | Experimental | Behavioral: Early language interventionChildren will receive 6 months of weekly parent-implemented intervention sessions. Children will be assessed monthly via audio recordings and language checklists to monitor language development more closely. |
| Monthly language check-ups | No intervention | –Children will be assessed monthly via home observations and parents will complete a language checklist to monitor language development more closely. |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 6 to 18 months of age
- bilateral, moderate to profound congenital hearing loss
Key exclusion criteria (3 listed)
- auditory neuropathy
- no known additional disabilities (e.g., cerebral palsy, Down syndrome)
- both parents have a severe to profound hearing loss
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 |
|---|---|---|
| Early language interventionParents will practice the specific set of strategies (visual, interactive, tactile, responsive) during sessions that occur weekly and last 1 hour for a total of 26 sessions, over 6 months. Each session will include four segments: (a) the therapist will review the intervention strategies taught in the workshop (10 min), (b) the therapist will model the intervention strategy with the child (10 min), (c) the parent will practice the strategy with her child with coaching from the therapist across four different routines and activities of the parent's choice (30 min), and (d) the therapist will provide feedback to the parent, summarize the session, and answer the parent's questions (10 min). | Behavioural | Early language intervention |
Primary outcome
MacArthur Communicative Development Inventories
Time frame: one month
1 secondary outcome
Preschool Language Scale
Time frame: 6 months
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 29 Mar 2018.
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A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
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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.
Megan Y Roberts, PhD, CCC-SLP principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early language intervention in people with Hearing Loss, run by Northwestern University 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 2 inclusion and 3 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 29 Mar 2018. 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?
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?
MacArthur Communicative Development Inventories (time frame: one month). 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 29 Mar 2018; AzTrials last refreshed its copy on 26 Oct 2026.