Online Parent-Report Evaluation of the Effects of Processed Music

Anxiety Clinical Trial

Official title:

Online Parent-Report Evaluation of the Effects of Processed Music

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05249270
• Other study ID #: 1912463776
• Status: Enrolling by invitation
• Start date: March 22, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims to examine effectiveness of the Safe and Sound Protocol (SSP) on sensory, digestive, and eating behaviors in children currently receiving therapy.

Description:

The SSP consists of listening to a computer altered sequence of vocal music that has been processed to "exercise" the neural regulation of the middle ear muscles. Low and high frequencies are dynamically filtered and presented monaurally to both ears. The intervention stimuli are delivered through headphones or speakers. The protocol consists of 60 minutes of listening on five sequential days and is delivered via a music player device in a quiet room without major distractors.

For this study, parents or legal guardians of children already enrolled to complete the SSP intervention at Children's Therapy of Woodinville will complete a series of surveys. The SSP is used as a component of therapy across multiple diagnostic categories including autism spectrum disorders and sensory processing disorder. No specific diagnoses will be targeted in this design. Parents will be recruited for the study if their child is already enrolled to receive the therapy. Participating parents will be asked to complete online questionnaires using a survey link at three intervals: before the start of therapy, one week after completion, and 1 month after completion.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Parent or legal guardian of child who is receiving the Safe and Sound Protocol at Children's Therapy of Woodinville (in Woodinville, WA)

• Parent must be 18 years or older

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Anxiety
• Autism Spectrum Disorder
• Deglutition Disorders
• Digestive System Diseases
• Disease
• Eating Disorders
• Feeding and Eating Disorders
• Gastro-Intestinal Disorder
• Gastrointestinal Diseases
• Intestinal Diseases
• Sensation Disorders
• Sensory Disorders
• Sensory Processing Disorder
• Swallowing Disorder

Locations

Country	Name	City	State
United States	Children's Therapy of Woodinville	Woodinville	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Children's Therapy of Woodinville

Country where clinical trial is conducted

United States, 

References & Publications (2)

Porges SW, Bazhenova OV, Bal E, Carlson N, Sorokin Y, Heilman KJ, Cook EH, Lewis GF. Reducing auditory hypersensitivities in autistic spectrum disorder: preliminary findings evaluating the listening project protocol. Front Pediatr. 2014 Aug 1;2:80. doi: 10.3389/fped.2014.00080. eCollection 2014. — View Citation

Porges SW, Macellaio M, Stanfill SD, McCue K, Lewis GF, Harden ER, Handelman M, Denver J, Bazhenova OV, Heilman KJ. Respiratory sinus arrhythmia and auditory processing in autism: modifiable deficits of an integrated social engagement system? Int J Psychophysiol. 2013 Jun;88(3):261-70. doi: 10.1016/j.ijpsycho.2012.11.009. Epub 2012 Nov 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory sensitivities	Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)	Change from baseline to 1 and 4 week post assessment
Secondary	Selective eating	Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)	Change from baseline to 1 and 4 week post assessment
Secondary	Ingestive problems	Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)	Change from baseline to 1 and 4 week post assessment
Secondary	Digestive problems	Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)	Change from baseline to 1 and 4 week post assessment