The Listening Project: Tuning Into Change
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Auditory hypersensitivity
研究概览
简要总结
A research project funded by the Australian Childhood Foundation (ACF) will be conducted in Australian facilities of the ACF to evaluate the effectiveness of the Listening Project Protocol (LPP) in children with a trauma history. The LPP is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural regulation of the middle ear structures to rehabilitate and to normalize the acoustic transfer function of the middle ear structures. The current study is being conducted to evaluate efficacy and feasibility of the LPP and will use objective measures to evaluate changes in acoustic transfer function of the middle ears structures, auditory processing skills, physiological state regulation, and sensory symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children must be between ages 7-14 years
- •Children and parent providing permission must be able to read/speak in English
- •Children must be receiving services from the Child Trauma Service unit of the Australian Childhood Foundation
排除标准
- •Children who wear a hearing-device
- •Children with a history of heart disease
- •Children who are currently being treated for seizure disorder
研究组 & 干预措施
Intervention group
Participants will be included in all pre-intervention and post-assessment measures. Participants will receive the Listening Project Protocol intervention. The duration of the intervention is approximately 45 minutes per day, for 5 consecutive days.
干预措施: Listening Project Protocol (Behavioral)
Assessment-only group
The assessment-only group will participate in all pre- and post-intervention assessments, but will not receive the Listening Project Protocol.
结局指标
主要结局
Auditory hypersensitivity
时间窗: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
次要结局
- Autonomic state regulation(pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention)
- Auditory processing(pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention)
- social behavior(post-intervention (within 1 week after the intervention), 1 month post-intervention)
- Middle ear muscle transfer function(pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention)