The Listening Program for Autism

Overseen By Caitlin Deville, MPT,DSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Health

Disqualifiers: Seizure disorder, Hearing impairments, Cerebral palsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a special music program using special headphones for children aged 5-10 with autism who are sensitive to sounds. The program uses special music to help their brains adjust to different sounds, aiming to reduce their sensitivity.

Who Is on the Research Team?

Suzanne Vercontaire

Principal Investigator

Children's Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child is between 5 and 10 years old.

I have someone to help me with my treatment sessions at home.

I have been diagnosed with autism spectrum disorder.

Exclusion Criteria

Non-English speakers

Cerebral palsy

I have been diagnosed with a seizure disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Demographic information collected and baseline assessments conducted

1 week

1 visit (in-person)

Intervention

Participants receive The Listening Program at home for 40 weeks

40 weeks

3 virtual check-ins at 10-week intervals

Post-Intervention

Post-treatment assessments conducted 1 week after intervention

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in adaptive behavior and sensory processing 3 months after treatment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• The Listening Program® with bone conduction headphones

Trial Overview 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.

How Is the Trial Designed?

Group I: The Listening Program® with bone conduction headphones Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Children's Health

Lead Sponsor

Trials

8

Recruited

460+