Online Parent-Report Evaluation of the Effects of Processed Music

August 16, 2024 updated by: Jacek Kolacz, Indiana University
The study aims to examine effectiveness of the Safe and Sound Protocol (SSP) on sensory, digestive, and eating behaviors in children currently receiving therapy.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Woodinville, Washington, United States, 98072
        • Children's Therapy of Woodinville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Safe and Sound Protocol Participants
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?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Children's Therapy of Woodinville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2020

Primary Completion (Actual)

June 28, 2022

Study Completion (Actual)

June 28, 2022

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 16, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1912463776

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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