Transitional Intervention for Hyperacusis in Autism
(TIHA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The main goal of this clinical trial is to evaluate the effectiveness, benefits, and post-treatment persistence of an intervention for loudness hyperacusis in adults with autism spectrum disorder (ASD). The main questions it aims to answer are:
* Does the intervention increase loudness tolerance
* Does the intervention reduce symptoms related to loudness hyperacusis Researchers will compare measures related to loudness hyperacusis before, during, and after the intervention.
Participants will:
* Be randomly assigned to either one of two groups. One group will receiver the intervention immediately. This group will be evaluated during the 6-month intervention and evaluated for 6 months after the end of the intervention. The other group will be evaluated for 6 months before the intervention and during the 6-month intervention.
* Visit the test site once every month over the course of a year for evaluation and intervention activities
* Keep a diary of their symptoms and the number of hours per day they engage in the intervention
Who Is on the Research Team?
David A. Eddins, Ph.D.
Principal Investigator
University of Central Florida
Kelly N. Jahn, Ph.D.
Principal Investigator
The University of Texas at Dallas
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with autism spectrum disorder who also experience loudness hyperacusis (sensitivity to everyday sounds).Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Transitional Intervention for Hyperacusis in Autism
Trial Overview
The study tests a new intervention designed to help people with autism tolerate loud sounds better. Participants are randomly assigned to start the intervention right away or after six months, and will be monitored monthly over one year.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Group AB receives intervention for 6 months followed by a 6-month watchlist period during which outcomes will be measured over 6 post-intervention months. The TIHA consists of three components: 1) structured counseling, 2) protective sound management, and 3) therapeutic sound. Structured counseling is to prepare the participant to transition from their current state, which most often involves counterproductive overuse of hearing protection devices and corresponding self-imposed sound isolation. Protective sound management limits exposure to sounds that are too loud for the individual participant while promoting and maximizing healthy exposure to safe and comfortable sound levels. This is achieved through custom fitting of the intervention hearing aid devices. Active sound therapy consists of soft, "seashell" - like noise delivered by the intervention hearing aid devices at an individualized level judged to be "soft, but comfortable."
The waitlist control group, BA, will be on a waitlist for intervention for 6 months during which outcomes will be measured at monthly intervals, followed by receipt of intervention for 6 months in a manner identical to group AB. The TIHA consists of three components: 1) structured counseling, 2) protective sound management, and 3) therapeutic sound. Structured counseling is to prepare the participant to transition from their current state, which most often involves counterproductive overuse of hearing protection devices and corresponding self-imposed sound isolation. Protective sound management limits exposure to sounds that are too loud for the individual participant while promoting and maximizing healthy exposure to safe and comfortable sound levels. This is achieved through custom fitting of the intervention hearing aid devices. Active sound therapy consists of soft, "seashell" - like noise delivered by the intervention devices at an individualized soft but comfortable level.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Central Florida
Lead Sponsor
The University of Texas at Dallas
Collaborator
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