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临床试验/NCT05249270
NCT05249270终止不适用

Online Parent-Report Evaluation of the Effects of Processed Music

Indiana University1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2020年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
132
试验地点
1
主要终点
Sensory sensitivities

研究概览

简要总结

The study aims to examine effectiveness of the Safe and Sound Protocol (SSP) on sensory, digestive, and eating behaviors in children currently receiving therapy.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • 未提供

结局指标

主要结局

Sensory sensitivities

时间窗: Change from baseline to 1 and 4 week post assessment

Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

次要结局

  • Selective eating(Change from baseline to 1 and 4 week post assessment)
  • Digestive problems(Change from baseline to 1 and 4 week post assessment)
  • Ingestive problems(Change from baseline to 1 and 4 week post assessment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacek Kolacz

Assistant Research Scientist

Indiana University

研究点 (1)

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