Online Parent-Report Evaluation of the Effects of Processed Music

Study Overview
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Brief Summary
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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
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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.

Official Title
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Online Parent-Report Evaluation of the Effects of Processed Music

Conditions
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Sensory Disorders, Sensory Processing Disorder, Autism Spectrum Disorder, Eating Disorders, Gastro-Intestinal Disorder, Swallowing Disorder, Anxiety

Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Safe and Sound Protocol Participants<br>Parents of children receiving the Safe and Sound Protocol (a clinical auditory therapy provided outside of the study) will complete questionnaires to assess sensory behaviors prior to therapy initiation (baseline), 1 week after therapy conclusion, and 4 weeks after therapy conclusion. The SSP typically consists of 1 hour of listening per day, for 5 consecutive days. If modifications of the typical dosage are implemented due to client needs, they will be documented by parents in the 1 week post therapy questionnaire. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory sensitivities | Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire) | Change from baseline to 1 and 4 week post assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Selective eating | Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire) | Change from baseline to 1 and 4 week post assessment | 
| Ingestive problems | Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire) | Change from baseline to 1 and 4 week post assessment | 
| Digestive problems | Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire) | Change from baseline to 1 and 4 week post assessment |