The Listening Project at the ADD Centre and Biofeedback Institute of Toronto
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline in auditory hypersensitivity at 1 week, and at 1 month
研究概览
简要总结
Purpose: A research project will be conducted at the ADD ("Attention Deficit Disorder") Centre and Biofeedback Institute of Toronto to evaluate the feasibility of the Listening Project Protocol (LPP) intervention in individuals with difficulties with autonomic and/or behavioral regulation. The LPP is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. These improvements should translate into increase feelings of safety and calmness, thereby promoting improvement in social behavior.
Participants: 30 participants, males and females between ages 7-55 years, will be recruited for the study. Participants will be patients at the ADD Centre and Biofeedback Institute of Toronto.
Procedures: Participants will be divided into 1 of 2 groups (1:1 ratio). Both groups will have a pre-intervention assessment #2, intervention, 1 week post intervention assessment and 1 month post intervention assessment. Group 2 will have an additional pre-intervention assessment session #1 (1 week previous to pre-intervention assessment #2) to assess the stability of the measures prior to starting the intervention. Pre-, post-, and 1 month followup assessment will include parent and/or self-report questionnaires, and measures of the individual's auditory processing ("SCAN"), affect recognition ("DARE" Dynamic Affect Recognition Evaluation), heart rate, prosody, "RSA" respiratory sinus arrhythmia (derived from non-invasive ECG recording), and middle ear transfer function ("MESAS" - Middle Ear Sound Absorption System).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals must be between ages 7-55 years
- •Individuals must be fluent (read and write) in English. Parents must be able to read/speak in English.
- •Individuals must be current or past clients at the ADD Centres Limited & Biofeedback Institute of Toronto
- •Exclusion criteria:
- •Individuals who wear a hearing-device
- •Individuals with a history of heart disease
- •Individuals who are currently being treated for seizure disorder
- •Individuals who are non-verbal
排除标准
- 未提供
结局指标
主要结局
Change from baseline in auditory hypersensitivity at 1 week, and at 1 month
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
- Change from baseline in social behavior at 1 week, and at 1 month(post-intervention (within 1 week after the intervention), 1 month post-intervention)
- Change from baseline in middle ear transfer function at 1 week, and at 1 month(pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention)
- Change from baseline in prosody at 1 week, and at 2 months(pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention)
- Change from baseline in attention (task) at 1 week, and at 2 months(pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention)
- Change from baseline in auditory processing at 1 week, and at 1 month(pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention)
- Change from baseline in state regulation at 1 week, and at 1 month(pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention)
- Change from baseline in attention at 1 week, and at 2 months(pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention)