Development of a Cognitive-Behavioral Intervention to Improve Infant and Parent Sleep Based on Big Data Analytics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Child sleep diary
研究概览
简要总结
This study aims to develop and test the intervention program to help manage parental thoughts in parents with child sleep problems.
详细描述
Pediatric sleep problems are common and persistent, which result in negative outcomes without appropriate intervention. Behavioral sleep interventions (BSI) are evidence-based sleep training methods for improving pediatric sleep. However, parental factors (e.g., parental dysfunctional beliefs about child sleep) can interfere with the implementation of BSI. For example, being too worried or having misperceptions about infant sleep may interfere with the parent's ability to successfully and persistently implement BSIs. Therefore, parental thoughts and beliefs should be considered as an important target in the context of pediatric sleep interventions. This study aims to develop a cognitive intervention that identifies and targets parental misperceptions about child's sleep, and test the efficacy of the intervention through a randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child's primary nighttime caregiver (mothers or fathers) of full-term, healthy, singleton, 6 to 24 months old
- •Caregiver participants aged between 19 to 65 years
- •The caregiver who is a native speaker of Korean (a person who is able to listen, speak, and write in Korean, and does not have any difficulties in understanding the Korean language)
- •Residents of South Korea
- •Sleep arrangements without restriction for using an auto-videosomnography device: (1) parent-child sleep separately (one should not change the sleep arrangement only for the participation in the study); (2) if parents and child share a bed, the child's own space should be large enough for the videosomnography camera to capture child body solely.
- •Be available on devices with the camera (e.g., tablets, personal computers) for the online intervention/session
排除标准
- •Child's gestational age before 37 weeks or after 42 weeks
- •Children with developmental disability
- •Caregiver participant (or partner) who is currently working the night shift or night duty
- •Caregiver participant who has a history of sleep disorders besides insomnia
- •Caregiver participant who has lifetime bipolar disorder, schizophrenia spectrum, and other psychotic disorders, alcohol, caffeine, or other substance substance-related disorders, neurocognitive disorders, thyroid-related disorders, or epilepsy
- •Caregiver participant who is currently experiencing a major depressive disorder, panic disorder (only if ≥ 4 nocturnal panic attacks in the past month), or post-traumatic stress-related problems
- •Caregiver participant who is using medications or substances that directly affect sleep
- •Caregiver participant who is currently getting cognitive behavioral therapy for insomnia (CBTi)
- •Pregnant women
结局指标
主要结局
Child sleep diary
时间窗: Changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Parent-report child's sleep diary will be collected. Sleep parameters include bedtime, wake time, total sleep time, sleep onset latency, wake time after sleep onset, and the number of awakenings. Total sleep time will be used as the main outcome.
Parental cognition about child sleep
时间窗: Changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Parental cognition about child's sleep will be measured by the Parental Understanding and Misperceptions about BAby Sleep-Questionnaire (PUMBA-Q). The score range is 0 to 92. Higher score represents higher levels of maladaptive cognition.
Child sleep (objective measurement)
时间窗: changes from baseline to 4 weeks
Child sleep will be objectively measured using the videosomnography. Sleep parameters such as bedtime, wake time, total sleep time, sleep onset latency, wake time after sleep onset, number of parental interventions, and number of awakenings are calculated by the algorithm. Total sleep time will be used as the main outcome.
次要结局
- Depression(changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention)
- Parental sleep diary(changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention)
- Parental sleep disturbance(changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention)
- Child sleep environment and parental interaction(changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention)
- Parental sleep (objective measurement)(changes from baseline to 4 weeks)
- Parental insomnia(changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention)
- Anxiety(changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention)
研究者
Sooyeon Suh
Associate professor
Sungshin Women's University