Speech-Language Teletherapy for Hearing Loss

Not currently recruiting at 4 trial locations

Overseen By Jihyun R Stephans, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Hearing aids, Cochlear implants

Disqualifiers: Global developmental delay, Trisomy 21, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 18 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of speech-language teletherapy (a remote therapy service) for young children who are deaf or hard-of-hearing. The study compares outcomes for children receiving traditional care with those receiving teletherapy, focusing on speech and language development. Children up to 27 months old with hearing loss, who are using or about to use hearing aids or cochlear implants, and whose families speak English or Spanish, may qualify. Participants will undergo assessments every 9 months to track progress over an 18-month period. As an unphased study, this trial provides families the chance to contribute to research that could enhance remote therapy options for young children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that speech-language teletherapy is safe for children with hearing loss?

Research shows that speech-language teletherapy is generally safe and well-received. Studies have found that children are happy with teletherapy, and no major negative effects have been reported. In one study, children who received teletherapy improved their language skills as much as those who had in-person therapy. This suggests teletherapy can be both effective and safe for young children with hearing loss. Since this trial is beyond the early research stages, the treatment appears safe enough to test with more children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Speech-Language Teletherapy for hearing loss because it offers a new, accessible way to provide therapy, especially for low-income families. Unlike traditional in-person therapy sessions, teletherapy can be delivered remotely, making it easier for families who might face challenges traveling to appointments. This method not only aims to enhance speech and language skills but also ensures that comprehensive assessments are regularly conducted. By integrating teletherapy with usual care, the approach seeks to deliver consistent support and potentially more effective outcomes over the 18-month study period.

What evidence suggests that speech-language teletherapy is effective for children who are deaf or hard-of-hearing?

Research shows that online speech therapy works well for children who are deaf or hard-of-hearing (D/HH). Studies have found that this therapy can improve speech and language skills, often achieving results similar to traditional in-person therapy. For example, one study found that children receiving online therapy improved more in 15 out of 24 language areas. Another study found that both in-person and online therapy effectively help children with hearing disabilities improve their speech and language skills. The trial will evaluate the effectiveness of speech-language teletherapy as a supplement to usual care for low-income families. This evidence suggests that online speech therapy can be a valuable way to help D/HH children with language development. ^{1 2 3 5 6}

Who Is on the Research Team?

Dylan K Chan, MD, PhD

Principal Investigator

The University of California - San Francisco

Are You a Good Fit for This Trial?

This trial is for deaf or hard-of-hearing children aged 0-27 months who primarily speak English or Spanish. They must have hearing loss confirmed by tests, be fitted with a hearing aid or cochlear implant, or have plans to do so within 3 months of joining the study. Children not pursuing spoken language, with moderate to severe developmental delays, receiving speech therapy outside this study, or with certain inner ear abnormalities are excluded.

Inclusion Criteria

Primary home language is English or Spanish, determined by electronic medical record or direct parent report

You have been diagnosed with hearing loss using specific tests.

Children who have moderate to severe hearing loss and are using a hearing aid or cochlear implant, or have been identified for fitting a hearing aid or activating a cochlear implant within 3 months of joining the study.

Exclusion Criteria

The family does not plan to help their child learn to listen and speak, according to what the parents say.

Speech-language teletherapy received through a clinical provider outside of this study at the time of enrollment, based on parent report

You have a significant delay in your overall development, as determined by a specialist.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Comprehensive speech, language, and quality-of-life assessments conducted at baseline

1 week

1 visit (in-person)

Treatment

Participants receive usual care or access to an 18-month course of speech-language teletherapy

18 months

3 visits (in-person) every 9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Speech-Language Teletherapy

Trial Overview The trial is testing if an 18-month speech/language teletherapy program can improve speech and language in deaf/hard-of-hearing children compared to usual care alone. It involves D/HH children who are publicly insured being randomly assigned to either the teletherapy group or usual care group; privately insured children will receive only usual care.

How Is the Trial Designed?

Group I: Usual Care + Teletherapy (Low-Income) Experimental Treatment 1 Intervention

This group includes the low-income families who satisfy the criteria to receive supplemental speech-language teletherapy and are randomized to receive the intervention. They will receive both 3x comprehensive assessments every 9 months AND access to supplemental speech-language teletherapy for the 18-month study period.

Group II: Usual Care (High-Income) Active Control 1 Intervention

This group will receive comprehensive assessments every 9 months for the 18-month period of enrollment, for a total of 3 assessments. They will not be randomized to receive supplemental teletherapy (intervention) and usual care.

Group III: Usual Care (Low-Income) Active Control 1 Intervention

This group includes the low-income families who satisfy the criteria to receive supplemental speech-language teletherapy but are not randomized to receive the intervention after allocation. Like the "Usual Care (High-Income) arm, they will only receive comprehensive assessments every 9 months for the 18-month period of enrollment, for a total of 3 assessments and usual care.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

In a 12-week study involving nine individuals with chronic aphasia, participants showed significant improvements in communication skills, with the Communicative Effectiveness Index increasing by an average of 17.8 points (p = .01) and the Communication Confidence Rating Scale improving by 10.4 points (p = .0004).

Participants also reported high satisfaction with the teletherapy services, and their independent practice of online language exercises increased over the course of the study, indicating that the combined approach of therapy and self-practice was effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Teletherapy and On-line Language Exercises in the Treatment of Chronic Aphasia: An Outcome Study. Steele, RD., Baird, A., McCall, D., et al.[2020]

Citations

1. pcori.org pcori.org/research-results/2020/comparing-effectiveness-telehealth-speech-and-language-therapy-among-young-children-hearing-loss

Comparing the Effectiveness of Telehealth Speech and ... This study compares the effectiveness of speech and language therapy delivered through telehealth versus standard care, among young children ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11407196/

Teletherapy to address language disparities in deaf and ... The specific aims of the study are to determine the effect of access to and utilisation of speech-language teletherapy in addressing language disparities in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11958003/

Outcomes of Aural Rehabilitation Provided in Person or by ... The telehealth group showed greater improvement on 15/24 of secondary language outcome measures. The findings provide evidence that telehealth is equivalent to ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT04928209

Teletherapy in Children Who Are Deaf and Hard of Hearing This study seeks to determine the effectiveness of speech/language teletherapy to address disparities in speech and language outcomes in children who are deaf ...

5. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/tmj.2023.0258

Comparing the Clinical Effectiveness of Telerehabilitation ... Conclusions: Traditional rehabilitation and telerehabilitation can effectively improve the speech and language skills of children with hearing disabilities. ...

6. leader.pubs.asha.org leader.pubs.asha.org/do/10.1044/leader.PA.27072022.telehealth-data.16/full/

New Outcomes Data Support Making Telehealth Policies ... NOMS data indicate patients were very satisfied with services they received via telehealth. Almost three-quarters said they were involved in the ...