Effectiveness of an Educational Program in Primary Schools to Prevent Noise-induced Hearing Loss
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The primary outcome is the child's recreational listening behavior when using earbuds or headphones, as reported by either the child or a parent (pending the validation study).
概览
简要总结
The goal of this randomized controlled trial is to evaluate the effectiveness of the educational program the HoorToren in promoting recreational safe listening behavior among Dutch primary school children in group 7 (aged 10-11 years) and thereby contribute to preventing noise-induced hearing loss. The main objectives are:
- To evaluate the HoorToren's effects on promoting the child's safe listening behavior when using headphones or earbuds. Both safe listening and its psychological determinants will be measured.
- To evaluate the HoorToren's effects on parents' perception of their child's safe listening behaviors. The effects on parental behavior promoting or facilitating their child's safe listening behavior, including its psychological determinants, will also be evaluated.
Researchers will compare children who receive lessons from the HoorToren educational program, and their parents (intervention group) with children and their parents who do not receive the lessons (control group) to evaluate the effectiveness of the HoorToren. Outcomes will be assessed using newly developed and validated self-report questionnaires for both children and their parents. Additionally, the child's listening behavior will be measured via a smartphone application installed on the child's phone. Measurements will take place at four time points during the school year.
详细描述
Results of the currently pending validation study will decide how the primary outcome (the child´s listening behavior) will eventually be defined, i.e. based on the child's versus the parent's report. The child's listening behavior as measured via the smartphone app is an important secondary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For schools: None.
- •For children:
- •Dutch primary school children in group 7 (corresponding to Year 6 in the UK).
- •Informed consent from legally authorized parent(s) or guardian(s).
- •Child is participating.
排除标准
- •For schools:
- •HoorToren package has been taught at group 6 in the previous school year.
- •For children:
- •Children without informed consent from legally authorized parent(s) or guardian(s).
- •Children who cannot read and write Dutch.
- •For parents:
- •Parents who cannot read and write Dutch
研究组 & 干预措施
Intervention arm
In this arm students receive seven lessons of the educational program the HoorToren, including 4 home assignments also targeting parents.
干预措施: HoorToren educational package (Other)
Control arm
In this arm students receive no lessons of the educational program the HoorToren.
结局指标
主要结局
The primary outcome is the child's recreational listening behavior when using earbuds or headphones, as reported by either the child or a parent (pending the validation study).
时间窗: The measurements will take place at the start of the study (baseline, i.e., pre-intervention), immediately post-intervention (2 months after baseline), 3 months post-intervention, and 7 months post-intervention.
The primary outcome measure will be assessed using newly developed and validated self-report questionnaires for children and parents. The final primary outcome (i.e. either child or parent-reported) will be chosen based on the pending validation study. The outcome will include a composite variable based on the self-reported listening duration and volume. The exact definition will depend on the validation study.
次要结局
- The child's recreational safe listening behavior when using earbuds or headphones with their own smartphone.(The measurements will take place at the start of the study (baseline, i.e., pre-intervention), immediately post-intervention (2 months after baseline), 3 months post-intervention, and 7 months post-intervention.)
- The child's psychological determinants of safe listening behavior.(The measurements will take place at the start of the study (baseline, i.e., pre-intervention), immediately post-intervention (2 months after baseline), 3 months post-intervention, and 7 months post-intervention.)
- Parents' psychological determinants related to promoting or facilitating safe listening behavior in their child.(The measurements will take place at the start of the study (baseline, i.e., pre-intervention), immediately post-intervention (2 months after baseline), 3 months post-intervention, and 7 months post-intervention.)
研究者
Marc P. van der Schroeff
MD, PhD, associate professor
Erasmus Medical Center