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Online Parent-Report Evaluation of the Effects of Processed Music

Online Parent-Report Evaluation of the Effects of Processed Music

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05249270
Enrollment
132
Registered
2022-02-21
Start date
2020-03-22
Completion date
2022-06-28
Last updated
2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Children's Therapy of Woodinville
CollaboratorUNKNOWN
Indiana University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Sensory sensitivitiesChange from baseline to 1 and 4 week post assessmentBrain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

Secondary

MeasureTime frameDescription
Selective eatingChange from baseline to 1 and 4 week post assessmentBrain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Ingestive problemsChange from baseline to 1 and 4 week post assessmentBrain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Digestive problemsChange from baseline to 1 and 4 week post assessmentBrain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026