Clinical trial NCT05249270: Online Parent-Report Evaluation of the Effects of Processed Music
Official title: Online Parent-Report Evaluation of the Effects of Processed Music
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sensory Disorders
Sensory Processing Disorder
Autism Spectrum Disorder
Eating Disorders
Gastro-Intestinal Disorder
Swallowing Disorder
Anxiety
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Children's Therapy of Woodinville
First posted: 2022-02-21
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents or legal guardians of children who are receiving the Safe and Sound Protocol at Children's Therapy of Woodinville (in Woodinville, WA)

Brief 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.

Detailed 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Sensory sensitivities
timeFrame: Change from baseline to 1 and 4 week post assessment
Secondary outcomes:
measure: Selective eating
timeFrame: Change from baseline to 1 and 4 week post assessment
measure: Ingestive problems
timeFrame: Change from baseline to 1 and 4 week post assessment
measure: Digestive problems
timeFrame: Change from baseline to 1 and 4 week post assessment
Other outcomes:
Locations:
city: Woodinville
country: United States
facility: Children's Therapy of Woodinville
state: Washington
Study officials:
References:
citation: 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.
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.