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The Listening Program for Autism

N/A
Waitlist Available
Led By Suzanne Vercontaire
Research Sponsored by Children's Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children between the ages of 5 and 10 years old
Diagnosis of autism spectrum disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up to be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment
Awards & highlights

Study Summary

This trial will test the efficacy of The Listening Program in children with ASD by measuring changes in adaptive life skills and behavioral responses.

Who is the study for?
This trial is for children aged 5-10 with Autism Spectrum Disorder who have issues with sound sensitivity. They must speak English and have a caregiver to supervise home listening sessions. It's not suitable for kids with cerebral palsy, seizure disorders, hearing impairments, previous listening therapy, or certain genetic diseases.Check my eligibility
What is being tested?
The study tests The Listening Program® using bone conduction headphones to see if it helps children with ASD who are overly sensitive to sounds improve their behavior and daily skills. The program uses low-frequency music over a recommended period of 40 weeks.See study design
What are the potential side effects?
Potential side effects aren't specified in the provided information but could include discomfort from wearing headphones or unexpected behavioral changes due to new sensory experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is between 5 and 10 years old.
Select...
I have been diagnosed with autism spectrum disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~to be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and to be administered at baseline, 1-week following a 40-week use of the listening program, and 3-months following treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline Adaptive Behavior Assessment System, Third Edition (ABAS-3) Score at 41 Weeks (Immediately Post-Treatment)
Secondary outcome measures
Pediatric Evaluation of Disability Inventory Computer Adaptive Test with ASD Scales (PEDI-CAT (ASD))
Other outcome measures
Autism Treatment Evaluation Checklist (ATEC)
Sensory Processing Measure™ (SPM™)

Trial Design

1Treatment groups
Experimental Treatment
Group I: The Listening Program® with bone conduction headphonesExperimental Treatment1 Intervention
The Listening Program ® Spectrum music requires a person listen to psycho-acoustically modified classical music online using specialized "Waves" ™ headphones. The headphones transmit sound through bone conduction which provides another mode of perceiving sound (https://advancedbrain.com). The Listening Program ® can be carried out in the home environment with either the base schedule, two fifteen minute sessions at least 30 minutes apart, or a condensed schedule for 30 minutes. Bone conduction allows the listening experience to go deeper into the vestibular system which is purported to reduce stress, help regulate the "fight or flight" response, and allow the listener to achieve a state of calm and relaxed alertness. This theory is based on the function of the vagus nerve, the 10th cranial nerve, which has branches that extend to the eardrum. Stimulation of the vagus nerve stimulates the parasympathetic nervous system (Allen, 2008).

Find a Location

Who is running the clinical trial?

Children's HealthLead Sponsor
7 Previous Clinical Trials
711 Total Patients Enrolled
Suzanne VercontairePrincipal InvestigatorChildren's Health

Media Library

The Listening Program® with bone conduction headphones Clinical Trial Eligibility Overview. Trial Name: NCT05009095 — N/A
Autism Spectrum Disorder Research Study Groups: The Listening Program® with bone conduction headphones
Autism Spectrum Disorder Clinical Trial 2023: The Listening Program® with bone conduction headphones Highlights & Side Effects. Trial Name: NCT05009095 — N/A
The Listening Program® with bone conduction headphones 2023 Treatment Timeline for Medical Study. Trial Name: NCT05009095 — N/A

Frequently Asked Questions

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

How many participants have registered for this research project?

"Affirmative, the information on clinicaltrials.gov indicates that this research trial is presently searching for participants. It was initially posted on June 13th 2022 and has been recently updated as of August 3rd 2022. There are 8 spots open at one medical facility currently available to be filled."

Answered by AI

Does the age limit for inclusion in this trial extend beyond 80 years?

"This medical study is currently recruiting patients aged between 5 and 10 years of age."

Answered by AI

Is it possible to partake in this clinical examination?

"This investigation seeks to enrol 8 individuals between ages 5 and 10 with a diagnosis of autism spectrum disorder."

Answered by AI

Can individuals still participate in this clinical test?

"According to the details available on clinicaltrials.gov, this trial is presently recruiting participants for inclusion. The initial listing was posted June 13, 2022 and recently revised August 3rd of the same year."

Answered by AI

Who else is applying?

What state do they live in?
Texas
New York
Pennsylvania
Other
How old are they?
< 18
18 - 65
What site did they apply to?
Childrens's Health Specialty Center Richardson
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

How responsive is this trial?

Typically responds via
Email
Recent research and studies
Developmental Medicine & Child NeurologyJournal
Validity, Reliability, and Usability of the Pediatric Evaluation of Disability Inventory-computer Adaptive Test for Autism Spectrum Disorders
Kramer, Jessica M, Kendra Liljenquist, and Wendy J Coster. 2015. “Validity, Reliability, and Usability of the Pediatric Evaluation of Disability Inventory-computer Adaptive Test for Autism Spectrum Disorders”. Developmental Medicine & Child Neurology. Wiley. doi:10.1111/dmcn.12837.
clinicaltrials.govStudy
The Listening Program® With Bone Conduction Headphones Changes Hypersensitivity to Sound and Behavioral Responses
Suzanne Vercontaire 2022. "The Listening Program® With Bone Conduction Headphones Changes Hypersensitivity to Sound and Behavioral Responses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05009095.
All > Asd > Allergy
~0 spots leftby Jun 2024
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