CLINICAL TRIAL

Speech-Language Teletherapy for Deafness

Recruiting · < 18 · All Sexes · Oakland, CA

This study is evaluating whether speech/language teletherapy can improve speech and language outcomes for children who are deaf or hard-of-hearing.

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About the trial for Deafness

Eligible Conditions
Deafness · Hearing Loss · Speech and Language Development Delay Due to Hearing Loss

Treatment Groups

This trial involves 2 different treatments. Speech-Language Teletherapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Speech-Language Teletherapy
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age 0-27 months;
bilateral sensorineural, mixed, or permanent conductive hearing loss with better-ear PTA > 20 dB.
single-sided deafness (unilateral SNHL with PTA > 70 dB);
unilateral complete aural atresia; or bilateral auditory-neuropathy spectrum disorder, as determined by ABR.
Primary home language is English or Spanish, determined by electronic medical record or direct parent report.
Currently fit with hearing aid or using a cochlear implant; OR Date identified for hearing-aid fitting or cochlear-implant activation within 3 months of enrollment.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 18 month
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 month
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 18 month.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Speech-Language Teletherapy will improve 1 primary outcome and 35 secondary outcomes in patients with Deafness. Measurement will happen over the course of 9 month, change from baseline.

Family Outcomes Survey (FOS) - 9 month change
9 MONTH, CHANGE FROM BASELINE
Family Outcomes Survey (FOS), a nationally recognized tool to assess a caregiver's perception of how well they, and their Early Intervention provider, can support their child's needs. It may be completed by parents of children of any age. We are using the Part B subscale, "Communicating your child's needs," as this was determined by the study to complement the existing data collection tools to uniquely assess the parent perception of impact of Early Intervention on parent education and efficacy. Parents are asked to answer these questions to reflect their entire Early Intervention experience, including all involved providers. It comprises 6 questions on a 5-point Likert scale. Scoring: maximum of 30 points, minimum of 6. Higher scores indicate greater perceived quality of Early Intervention services. It will be administered by the Research Coordinator. Age range: 0-18 years Language: English or Spanish Scores to report: Total score difference
9 MONTH, CHANGE FROM BASELINE
Parent Evaluation of Aural/Oral Performance of Children (PEACH) - 9 month change
9 MONTH, CHANGE FROM BASELINE
The Parent Evaluation of Aural/Oral Performance of Children (PEACH) is a validated measure used by audiologists and hearing health professionals to evaluate the effectiveness of a child's use of hearing in real-world environments. It will be administered by the Research Coordinator at each study site or obtained from clinical chart review. Raw scores are converted to a percentage of the maximum points on the instrument, for a maximum score of 100 and minimum of 0. Higher scores indicate higher auditory function. Age range: 0-60 months. Language: English or Spanish. Score to report: Raw score (Percentage) difference
9 MONTH, CHANGE FROM BASELINE
Scale of Parental Self-Efficacy (SPISE) - 9 month change
9 MONTH, CHANGE FROM BASELINE
Scale of Parental Self-Efficacy (SPISE) a parent-report measure of a parent's comfort level in addressing their D/HH child's needs and supporting their communication development. It may be completed by parents of children of any age. To reduce survey burden, we identified a subset of questions to use for this study. Exploratory factor analysis was performed on a retrospective cohort of children who are D/HH to identify items that would provide equivalent discriminant and construct validity to the full survey. It comprises. 8 questions on a 7-point Likert scale. Scoring: maximum of 56 points, minimum of 8. Higher scores indicate greater self-efficacy. It will be administered by the Research Coordinator. Age range: 0-18 years Language: English or Spanish Scores to report: Total score difference
9 MONTH, CHANGE FROM BASELINE
Hearing-Related Infant/Toddler and Parent Quality of Life (HIP-QL) - 9 month change
9 MONTH, CHANGE FROM BASELINE
The Hearing-Related Infant/Toddler and Parent Quality of Life (HIP-QL) is a validated instrument consisting of 17 questions across 3 domains on a 7-point Likert scale assessing the QOL of a D/HH child 0-42 months old and their caregiver. Scoring: maximum of 119 points, minimum of 17. Higher scores indicate greater quality of life. It will be administered by the Research Coordinator. Age range: 0-42 months. Language: English or Spanish Scores to report: Total score difference
9 MONTH, CHANGE FROM BASELINE
PLS-5 Total Language (TL) Standard Score - 9 month change
9 MONTH, CHANGE FROM BASELINE
The Preschool Language Scales - Fifth Edition (PLS-5) is a developmental language assessment that focuses on receptive and expressive language skills and provides both norm-referenced and criterion referenced scores. This subscale assesses Total Language Communication. Scoring: Standard score (age-normed mean set at 100, standard deviation = 15, higher score indicates better language). It will be administered by the Research SLP at each study site. Age range: Birth through 7:11. Language: English or Spanish. Score to report: standard score difference
9 MONTH, CHANGE FROM BASELINE
PLS-5 Expressive Communication (EC) Standard Score - 9 month change
9 MONTH, CHANGE FROM BASELINE
The Preschool Language Scales - Fifth Edition (PLS-5) is a developmental language assessment that focuses on receptive and expressive language skills and provides both norm-referenced and criterion referenced scores. This subscale assesses Expressive Communication. Scoring: Standard score (age-normed mean set at 100, standard deviation = 15, higher score indicates better expressive communication). It will be administered by the Research SLP at each study site. Age range: Birth through 7:11. Language: English or Spanish. Score to report: standard score difference
9 MONTH, CHANGE FROM BASELINE
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the latest research for deafness?

Current research on deafness is relevant to clinicians when it comes to diagnosis and treatment. This article describes the different types of Deafness, the current research in this area, and the treatment algorithms outlined for each condition because a proper diagnosis is important.

Anonymous Patient Answer

How does speech-language teletherapy work?

[In a recent study, findings confirms that teletherapy provides improvements in auditory and speech perception abilities when compared with a more conventional rehabilitation pathway.] [power (https://www.bioethics.wustl.edu/sites/bioethics.wustl.edu/files/content/BiolEth/SUBJ/speech.pdf)] The speech-language pathologists involved in this study were experienced speech-language therapists from a speech-language-pathology (SLP) program who also provided the teletherapy in the clinic, which implies that this teletherapy was more akin to an intervention provided by a clinician than a self-initiated intervention.

Anonymous Patient Answer

What causes deafness?

Hearing loss is the result of the inability of the ear to detect sound waves and the destruction of the delicate fibers that carry sounds to the brain. Hearing loss is caused by a wide variety of conditions that strike a critical structure. Hearing loss can be caused by a number of different conditions that affect the ear or the nerves leading to it, but typically it starts with changes that occur in the ear itself or along the pathway by which sound is transmitted through the inner ear to the brain. These changes can be external or systemic.\n

Anonymous Patient Answer

Can deafness be cured?

Deafness does not respond to any intervention regimen that has been tried so far. However, it is possible that some therapies might have some effect in certain cases.

Anonymous Patient Answer

What are common treatments for deafness?

It is common for students with hearing loss to be enrolled in a full deaf education program. In addition, the majority of students receive support to facilitate their acquisition of speech and language through speech therapy. Hearing aids are one of the most common treatment options. Furthermore, some educators are trained in using hearing aids for children who cannot hear. Although hearing aids provide a positive impact on daily functioning, they may be perceived as stigmatizing to some. Thus, many children choose to wear cochlear implants that provide a positive impact on their lives. In one study, it was found that most children who received implants perceived themselves to be better communicators after receiving the device.

Anonymous Patient Answer

How many people get deafness a year in the United States?

Approximately 3,300 people in the United States are born with hearing loss annually. Nearly half of all deaf people are children, and 80% are born before the age of 18. Deafness is the most common handicapped condition in the United States. The incidence in the United States exceeds twice the national average for other European countries. In the United States, the most common cause of nonsyndromic deafness is a disorder on the inner ear. Deafness, like other neuromuscular disorders, occurs as a result of complex interactions involving genetic, environmental and cultural factors. In the United States, approximately 75% of the deaf are minorities (mostly American Indians).

Anonymous Patient Answer

What are the signs of deafness?

Signs that are present in deafness can be identified on the basis of physical examination or hearing. While most of the physical examination findings are common with a range of health conditions, some signs are specific to deafness. These can include changes in gait, posture, and speech that are specific to deafness.

Anonymous Patient Answer

What is deafness?

This dictionary of hearing loss is the most reliable resource as it is the most accessible, most complete information on hearing loss. It can be easily reviewed and revisited when desired. It allows the user to locate information on hearing loss by name, cause and severity and allows the reader of the dictionary to quickly locate a specific area of interest.

Anonymous Patient Answer

Who should consider clinical trials for deafness?

Deaf people should be more willing to consider clinical trials for hearing loss. There are clinical trials for hearing loss, and even some for cochlear implants. There are no studies involving deaf people to evaluate other cochlear implants. There are also clinical trials for refractive or surgical correction of binocular vision or other vision disorders, and hearing impairment such as tinnitus or otosclerosis. It is advisable to use a multi-disciplinary approach in the process of considering clinical trials. The inclusion and exclusion criteria need to be reviewed.

Anonymous Patient Answer

What are the latest developments in speech-language teletherapy for therapeutic use?

Since the mid-1960s, speech-language teletherapy has continually evolved in response to the ever-increasing need for new clinical applications. This article discusses some of the new ways speech-language teletherapy is being applied in the fields of developmental disorders, developmental disabilities, and communication disorders. In addition, there are a variety of software applications (e.g. Wordnet, Fingertalk), and web-based applications available for the professional use of speech-language teletherapy.

Anonymous Patient Answer

Does deafness run in families?

This preliminary study shows a significant positive correlation between deafness and deafness-related traits in siblings. This result is most likely due to mutation in or linkage of DFNA8, which is associated with both hearing loss and deafness. Further analysis of this cohort is warranted, especially as this preliminary finding is highly promising.

Anonymous Patient Answer

What is speech-language teletherapy?

In a recent study, findings of this study are a beginning to the knowledge about the efficacy and feasibility of speech-language telephone therapy that might prove beneficial in the management of some pediatric swallowing disorders.

Anonymous Patient Answer
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