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Speech-Language Teletherapy for Hearing Loss
N/A
Recruiting
Led By Dylan K Chan, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 month
Awards & highlights
Study Summary
This trial will study whether speech and language teletherapy can help improve outcomes for deaf or hard-of-hearing children. 140 children who are publicly insured will be randomly assigned to either receive the therapy or usual clinical care, while 70 privately insured children will only receive usual care. Assessments will be done at the start of the study and then every 9 months to see if there are any improvements.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention involves educational and therapeutic activities rather than medical treatments, traditional side effects associated with medications are not expected. However, there may be indirect effects such as frustration or fatigue during sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PLS-5 Auditory Comprehension (AC) Standard Score - 18 month
Secondary outcome measures
Family Outcomes Survey (FOS) - 18 month
Family Outcomes Survey (FOS) - 18 month change
Family Outcomes Survey (FOS) - 9 month
+32 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Usual Care + Teletherapy (Low-Income)Experimental Treatment1 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 Control1 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 Control1 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.
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,503 Previous Clinical Trials
15,236,445 Total Patients Enrolled
4 Trials studying Hearing Loss
28,174 Patients Enrolled for Hearing Loss
Patient-Centered Outcomes Research InstituteOTHER
549 Previous Clinical Trials
29,996,338 Total Patients Enrolled
5 Trials studying Hearing Loss
30,668 Patients Enrolled for Hearing Loss
Dylan K Chan, MD, PhDPrincipal InvestigatorThe University of California - San Francisco
1 Previous Clinical Trials
28,000 Total Patients Enrolled
1 Trials studying Hearing Loss
28,000 Patients Enrolled for Hearing Loss
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The family does not plan to help their child learn to listen and speak, according to what the parents say.You have a significant delay in your overall development, as determined by a specialist.You have been diagnosed by an audiologist or ear, nose, and throat doctor as not being able to hear well.Children will be excluded if they have severe hearing loss in both ears and cannot have a cochlear implant, or if they have certain bone abnormalities that may affect the success of a cochlear implant.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.You are between 0 and 27 months old.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care + Teletherapy (Low-Income)
- Group 2: Usual Care (High-Income)
- Group 3: Usual Care (Low-Income)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment for this trial open to individuals of advanced age?
"The trial is open to patients who are younger than 27 months and have surpassed 0 months of age."
Answered by AI
Is my profile suitable for participation in this research?
"This experiment requires patients with hearing difficulties, who have not surpassed their 27th month of life. At this stage, the research team is recruiting 210 participants to join in on the trial."
Answered by AI
In what capacity are the sites administering this clinical experiment?
"The 5 sites for this trial are Rady Children's Hospital - San Diego in San Diego, UCSF Benioff Children's Hospital - Oakland in Oakland, Lucile Packard Children's Hospital Stanford in Palo Alto and two other unnamed locations."
Answered by AI
Are there opportunities for participants to join this clinical investigation currently?
"The facts on clinicaltrials.gov suggest that this medical trial is still actively recruiting participants, with the initial posting of it being July 15th 2021 and last edit occurring October 12th 2022."
Answered by AI
To what extent is participation increasing in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this investigative trial is currently in search of applicants. The registration for the study began on July 15th 2021 and was updated most recently on October 12th 2022; 210 patients need to be enrolled from 5 different research centres."
Answered by AI
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