CLINICAL TRIAL

Parent Training Intervention for Deafness

Recruiting · Any Age · All Sexes · Lexington, KY

This study is evaluating whether a parent training program can be adapted to work with parents of young deaf children.

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About the trial for Deafness

Eligible Conditions
Parenting · Deafness · Hearing Loss · Children Behavior

Treatment Groups

This trial involves 2 different treatments. Parent Training Intervention 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.
Parent Training Intervention
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex of any age. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Parent is age 18 or older
Parent expects to live in Kentucky for the next 3 years
Child is deaf or hard of hearing
Child has used hearing aid(s), cochlear implant(s) and/or bone conduction device(s) for greater than 6 months
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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: 12 months, 24 months, 36 months (children ages 3 years +)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months, 24 months, 36 months (children ages 3 years +).
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 Parent Training Intervention will improve 1 primary outcome, 8 secondary outcomes, and 8 other outcomes in patients with Deafness. Measurement will happen over the course of 12 months, 24 months, 36 months after baseline.

Data-logging of hearing aid/cochlear implant use by child
12 MONTHS, 24 MONTHS, 36 MONTHS AFTER BASELINE
as available from audiological medical records
Dyadic Parent-Child Interaction Coding System (DPICS)
12 MONTHS, 24 MONTHS, 36 MONTHS AFTER PARENT BASELINE
observational measure of parent-child interaction quality
Hearing Aid Adherence Questionnaire
12 MONTHS, 24 MONTHS, 36 MONTHS AFTER PARENT BASELINE
parent-report use of hearing aids by child
Change in Parenting Young Children scale (PARYC) scores over time
6 MONTHS, 12 MONTHS, 18 MONTHS, 24 MONTHS, 30 MONTHS, 36 MONTHS AFTER PARENT BASELINE
While the primary study outcomes is PARYC scores 6 months after baseline, we will also assess differences in changes over 3 years in PARYC scores within and between study arms
Meaningful Auditory Integration Scale (MAIS)
12 MONTHS, 24 MONTHS, 36 MONTHS AFTER PARENT BASELINE
parent report of child's language skills in real-world situations
MacArthur Bates Communicative Development Inventories
12 MONTHS, 24 MONTHS, 36 MONTHS AFTER PARENT BASELINE
parent-report of children's developing abilities in early language
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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 are common treatments for deafness?

Dealing with the complexities of deafness requires a multidisciplinary approach that is tailored to meet each individual's needs. Patients frequently require a speech pathologist, audiologist, and professional interpreters.

Anonymous Patient Answer

Can deafness be cured?

The first clinical evidence for the ability to "cure" deafness has been reported in the literature for over a century. Current understanding of the genetics and neurobiology of hearing loss should not preclude the prospect of such treatment potential.

Anonymous Patient Answer

What is deafness?

What is deafness? The term deafness is often used to mean profound sensorineural deafness, but deafness is a more accurate term since it includes profound mixed-signal deafness and/or moderate SNHL. A hearing loss is a condition in which a person is unimpaired in any respect but cannot hear well enough to benefit from everyday conversations. Deafness refers more specifically to the sensorineural loss of hearing.

Anonymous Patient Answer

What are the signs of deafness?

Signs of hearing loss include difficulty making a clear, loud sound or tuning in or out. There may be tiredness or ringing in the ears. There are also signs of balance problems including the feeling that a person is swaying and light-headedness.\n\nA diagnosis may be made by hearing aids and stethoscopes. Signs of hearing loss may be treated by hearing aids.\n\nor by the presence of auditory verbal hallucinations.\n\n- Audio-visual processing disorder (ASPD) – a disturbance of audio or visual perception, thought, memory or behavior.

Anonymous Patient Answer

What causes deafness?

Deafness occurs due to damage to the acoustic nerve or its bundle, or by other causes such as viral disease. Many kinds of trauma can damage the nerve of hearing. The type of trauma is influenced by the circumstances of the injury and the level of hearing that was lost.

Anonymous Patient Answer

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

Around 70,000 deaf children are currently living in the United States. These individuals represent approximately 3.27/1000 people, which is a very low rate of deafness. Deaf individuals do not have a worse quality of life, and they tend to live longer compared to their hearing counterparts.

Anonymous Patient Answer

What is parent training intervention?

Data from a recent study showed that PTO is effective both in school children with autism and in deaf children with a history of deafness through peer communication. We suggest that it may be used as a family-oriented intervention in these groups to improve health literacy and social competence.

Anonymous Patient Answer

Who should consider clinical trials for deafness?

The study has implications for patient selection for clinical trials and for allocation of resources between new therapies and existing treatments. Results from a recent clinical trial suggest that certain treatments have demonstrated efficacy for certain subsets of deaf people. At present, it is not known whether a particular subset of deaf people are likely to benefit from a given treatment. Clinical trials may provide useful information on this issue, because they provide a more efficient way of identifying and assessing the efficacy of new treatments.

Anonymous Patient Answer

What are the latest developments in parent training intervention for therapeutic use?

This article reports recent progress in parent training, in the area of the acquisition of spoken communication skills, with particular attention to deaf children. Given the lack of adequate knowledge in these fields with regard to linguistic processing abilities in hearing people, our findings provide strong arguments to be included as a mandatory core course in the teaching program of Sign Language.

Anonymous Patient Answer

What is the latest research for deafness?

Deafness is a [complex condition], where the exact cause remains unknown at present. Hearing loss does not always occur immediately and a diagnosis of deafness may be delayed because the loss of hearing is gradual (latency). The lack of knowledge and awareness about deafness continues to have serious impacts because people who are deaf find it hard to form relationships and often feel isolated. There are many types of deafness, and current research is focusing on two main areas: the development of new hearing aids and biomedical innovations that allow the inner ear to function better.

Anonymous Patient Answer

What is the average age someone gets deafness?

[The average age people receive permanent deafness is 42] (https://www.niams.nih.gov/news-events/news-releases/2015/fda-deafness-new-access-for-adult-and-pediatric-patients/). Although most patients are diagnosed by ages 15–34, there are [overall] 2,500 people diagnosed per year who are older than 60 and are profoundly deaf (https://www.niams.nih.gov/news-events/news-releases/2015/fda-deafness-cures-determined-for-patients-deaf-lung-disease).

Anonymous Patient Answer

Is parent training intervention typically used in combination with any other treatments?

Parent training was most commonly used in conjunction with (but does not have to be part of) other interventions, particularly behavioral therapy and other pharmacological treatments. It is warranted that all approaches used to treat hearing loss and developmental delay take into account their own limitations, strengths, and appropriate uses.

Anonymous Patient Answer
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