Online Parent-Report Evaluation of the Effects of Processed Music

Terminated

• Conditions: Autism Spectrum Disorder; Anxiety; Sensory Processing Disorder; Eating Disorders; Sensory Disorders; Gastro-Intestinal Disorder; Swallowing Disorder

• Registration Number: NCT05249270
• Lead Sponsor: Indiana University

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 Timeline

• Study Start: 2020-03-22
• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-02-21
• Primary Completion: 2022-06-28
• Study Completion: 2022-06-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensory sensitivities	Change from baseline to 1 and 4 week post assessment	Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

Secondary Outcome Measures

Name	Time	Method
Digestive problems	Change from baseline to 1 and 4 week post assessment	Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Selective eating	Change from baseline to 1 and 4 week post assessment	Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Ingestive problems	Change from baseline to 1 and 4 week post assessment	Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

Trial Locations

Locations (1)

Children's Therapy of Woodinville; 🇺🇸 Woodinville, Washington, United States