Online Parent-Report Evaluation of the Effects of Processed Music
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Indiana University
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Sensory sensitivities
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
Sensory sensitivities
Time Frame: Change from baseline to 1 and 4 week post assessment
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Secondary Outcomes
- Digestive problems(Change from baseline to 1 and 4 week post assessment)
- Selective eating(Change from baseline to 1 and 4 week post assessment)
- Ingestive problems(Change from baseline to 1 and 4 week post assessment)
Investigators
Jacek Kolacz
Assistant Research Scientist
Indiana University