NCT01489215Unknown不适用
Interventions for Sleep Problems in Early Childhood:The Role of Child, Parental and Intervention Factors
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 主要终点
- Improved infant sleep
研究概览
简要总结
This study will inform the field about underlying mechanisms associated with infant sleep problems and will deepen the understanding of the intervention process. The study will provide detailed information on the intervention process itself and will explore how behavioral sleep interventions affect broader infant outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •infants at age range 9-18 months;
- •healthy infants with no significant health problems;
- •two-parents families;
- •parents who master the Hebrew language.
- •significant sleep problem lasting more than 3 months:
- •Our definition for a significant sleep problem in this age range is based on meeting at least one of the following three criteria for the baseline week:
- •an average of three or more night-wakings per night;
- •an average wake period of at least 30 minute per night between sleep onset and morning rise time;
- •more than 30 minutes to fall asleep each night with protests for attention.
排除标准
- •Infants not meeting the inclusion criteria at the baseline assessment will be excluded from the study.
结局指标
主要结局
Improved infant sleep
时间窗: base line to one month follow-up
Less parental involvement in falling asleep, less night wakings, heightened sleep efficacy
次要结局
- improvement in infant emotion regulation and in parent-infant interaction(one month follow-up to one year follow-up)
研究者
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