Efficacy of Parental Sleep Intervention on Infants and Toddlers With Behavioural Insomnia: A Longitudinal Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sleep efficiency (SE) measured by Actigraphy
研究概览
简要总结
The global incidence of mental illness among children and adolescents is rising, drawing increasing attention to early risk factors and preventive strategies. Behavioral sleep problems, which affect up to 50% of infants in the local population, are closely linked to impaired self-regulation-a core factor underlying many psychological disorders and a promising target for early intervention. Enhancing self-regulation may not only alleviate sleep problems but also mitigate long-term mental health risks. This study aims to develop an intervention toolkit based on current guidelines and high-quality evidence, integrating parent education with dynamic sleep assessment and longitudinal evaluation of self-regulation in infants. The project seeks to establish the efficacy of this approach, identify moderators of intervention outcomes, and provide an evidence base for personalized sleep interventions in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-36 months
- •Diagnosed with behavioural insomnia (sleep latency > 20 minutes and/or ≥ 2 nighttime awakenings per night, each lasting at least 5 minutes)
- •Daytime functional impairment (eg., excessive sleepiness, inattention, emotional problems)
- •Parental consent for participation
排除标准
- •Chronic diseases
- •History of head trauma
- •Other primary sleep disorders (e.g., obstructive sleep disorder, narcolepsy, restless leg syndrome)
- •Developmental delay, epilepsy, or other neurological/metabolic disorders
- •Participation in a new intervention program within the past 4 weeks, and/or initiation of new medication within the past 4 weeks.
结局指标
主要结局
Sleep efficiency (SE) measured by Actigraphy
时间窗: Baseline, 1 month, 6 months and 12 months
Sleep efficiency is defined as the percentage of total sleep time (sleep period determined by the actigraphy) to the total time spent in bed (from the time children go to bed to the time they finally get up in the morning). A higher percentage reflects more continuous and higher-quality sleep. As SE is closely related to SOL and nighttime awakings, it is selected as the primary outcome of the current study.Through the built-in accelerometer and other sensors, the actigraphy can be used to monitor an individual's activity level and sleep situation, thereby analysing the child's sleep patterns such as sleep efficiency. The team technician will export the relevant sleep indicators recorded by the actigraphy and calculate relevant outcome measures. Moreover, the actigraphy is validated with parental records of sleep diaries.
Nighttime sleep efficiency measured by Actigraphy
时间窗: Baseline, 1 month, 6 months and 12 months
Sleep efficiency is defined as the percentage of total sleep time (sleep period determined by the watch) to the total time spent in bed (from the time children try to fall asleep to the time they finally wake up in the morning). A higher percentage represents a more continuous and higher-quality night's sleep. Through the built-in accelerometer and other sensors, the actigraphy can be used to monitor an individual's activity level and sleep situation, thereby analysing the child's sleep patterns such as nighttime sleep efficiency. The team technician will export the relevant sleep indicators recorded by the actigraphy and calculate relevant outcome measure. Moreover, the actigraphy is validated with parental records of sleep diaries.
Daytime napping pattern measured by Actigraphy
时间窗: Baseline, 1 month, 6 months and 12 months
Record children's sleep behaviour during the day with the actigraphy. Two main indicators are evaluated: 1. Number of naps: the number of independent sleep events that occurred during the day and lasted to the actigraphy's recognition criteria. 2. Total nap duration: cumulative time (minutes) for all sleep events during the day (defined as the time between the last awakening in the morning and the time you go to bed at night). This outcome measure is mainly reflected by the average time of daytime napping per day, which will be reported at different points to assess sleep-wake distribution throughout the day.
Nocturnal awakening pattern measured by Actigraphy
时间窗: Baseline, 1 month, 6 months, and 12 months
The actigraphy is used to objectively quantify wakefulness events during nighttime sleep. Two main indicators are evaluated: 1. Number of awakenings: the total number of awakening events that meet the actigraphy's recognition criteria each time during the main sleep period. 2. Total Awakening Duration: the cumulative time (minutes) of all awakening events that meet the criteria. This outcome measure is reflected by the average total duration of nocturnal awakenings per day, which will be reported to assess the degree of fragmentation of nighttime sleep.
Subjective sleep quality measured by the Brief Infant Sleep Questionnaires (BISQ)
时间窗: Baseline, 1 month, 6 months, and 12 months
BISQ is a questionnaire tool used to assess the sleep of infants. The questionnaire aims to collect information on infant sleep behaviour through parent-reported methods to help professionals more fully understand and evaluate infants' sleep quality and patterns. This questionnaire evaluates the changes in children's sleep duration, co-sleeping situation, night-waking situation, falling-asleep situation, and overall sleep patterns.
次要结局
- Sleep onset latency (SOL) measured by Actigraphy(Baseline, 1 month, 6 months and 12 months)
- Wake after sleep onset (WASO) measured by Actigraphy(Baseline, 1 month, 6 months, and 12 months)
- The number of nighttime awakenings (NW) measured by Actigraphy(Baseline, 1 month, 6 months and 12 months)
- Subjective sleep quality measured by the Brief Infant Sleep Questionnaires (BISQ)(Baseline, 1 month, 6 months, and 12 months)
- Subjective sleep quality measured by the Infant/Toddler Sleep Assessment Scale (ISAS/TSAS)(Baseline, 1 month, 6 months, and 12 months)
- Self-regulation ability measured by the Age and Stage Questionnaires: Social and Emotional-2 (ASQ:SE-2)(Baseline, 1 month, 6 months, and 12 months)
- Self-regulating ability measured by the Age and Stage Questionnaires: Social and Emotional-2 (ASQ:SE-2)(Baseline, 1 month, 6 months, and 12 months)
- Temperament measured by the series of Carey Children Temperament Questionnaire(Baseline and 12 months)
研究者
Tingyu Rong
Resident/Assistant research fellow
Children's Hospital of Soochow University