Speech-Language Teletherapy for Hearing Loss

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

211 Participants Needed

Trial Summary

What is the purpose of this trial?

This study seeks to determine the effectiveness of speech/language teletherapy to address disparities in speech and language outcomes in children who are deaf or hard-of-hearing (D/HH). The investigators will enroll D/HH children aged 0-27 months. 140 children who are publicly insured will be randomized to receive usual clinical care or to be given access to an 18-month course of speech-language teletherapy program. 70 children who are privately insured will also be enrolled and will receive usual care. Children will undergo, at baseline and every 9 months thereafter to a study endpoint of 18 months, for a total of 3 timepoints, a battery of in-person and parent-report assessments designed to provide a comprehensive measurement of the child's auditory function, speech, verbal- and non-verbal communication, spoken language, and quality of life.

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 data supports the effectiveness of the treatment Speech-Language Teletherapy for Hearing Loss?

Research shows that telemedicine, including speech-language teletherapy, can be effective for teaching listening and spoken language to children with hearing loss, with high satisfaction reported by both parents and therapists. Additionally, teletherapy has been shown to improve communication skills in individuals with chronic aphasia, suggesting its potential effectiveness for other communication-related conditions. ^{1 2 3 4 5}

Is Speech-Language Teletherapy safe for humans?

Research on teletherapy for speech and language disorders, including for children with hearing loss, shows high satisfaction among parents and therapists, suggesting it is a safe and effective alternative to in-person therapy. Teletherapy has been successfully used during the COVID-19 pandemic, with parents reporting positive experiences and improved motivation for therapy. ^{2 3 6 7 8}

How is Speech-Language Teletherapy for Hearing Loss different from other treatments?

Speech-Language Teletherapy for Hearing Loss is unique because it allows therapy to be delivered remotely, making it more accessible and convenient, especially for those in rural or remote areas. This approach can be as effective as in-person sessions, providing similar language development outcomes for children with hearing loss. ^{2 3 6 9 10}

Research Team

Dylan K Chan, MD, PhD

Principal Investigator

The University of California - San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Physical outcome measures for conductive and mixed hearing loss treatment: A systematic review. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Satisfaction with telemedicine for teaching listening and spoken language to children with hearing loss. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Translating Enhanced Conversational Recast to a Telepractice Setting. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Combining Teletherapy and On-line Language Exercises in the Treatment of Chronic Aphasia: An Outcome Study. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of Voice Therapy Outcomes: Clinic vs Telehealth. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A pilot study of telepractice delivery for teaching listening and spoken language to children with hearing loss. [2014]

7. India pubmed.ncbi.nlm.nih.gov

Parent's Perspective on Teletherapy of Pediatric Population with Speech and Language Disorder During Covid-19 Lockdown in India. [2023]

8. Brazil pubmed.ncbi.nlm.nih.gov

The COVID-19 pandemic and the implementation of telehealth in speech-language and hearing therapy for patients at home: an experience report. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

An Exploratory Investigation of E-Rest: Teletherapy for Chronically Aphasic Speakers. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Transitioning Speech-Language Assessment to a Virtual Environment: Lessons Learned From the ELLA Study. [2022]