Early Childhood Insomnia: Underlying Mechanisms of Intervention Effects of the "Bedtime Checking" and the "Standard Checking" Methods
概览
- 阶段
- 不适用
- 干预措施
- bedtime intervention for early childhood insomnia
- 疾病 / 适应症
- Insomnia
- 发起方
- Ben-Gurion University of the Negev
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Change in infant actigraphic number of night-wakings from baseline to 1-week and 2-week start of intervention
- 状态
- 招募中
- 最后更新
- 17天前
概览
简要总结
Behavioral insomnia of childhood affects 15-30% of infants. Behavioral interventions, based on limiting parent-child bedtime and nighttime interactions, are effective in significantly improving infant sleep problems. However, the implementation of these interventions frequently encompasses significant infant crying and parental distress that deter many parents. Research on gradual sleep interventions that involve a lower "dose" of parent-infant separation, and thus may be more acceptable by parents, has so far been sparse. The proposed study aims to advance research in this area through systematically studying the processes through which parent and infant factors impact treatment outcomes of a behavioral intervention method that involves parent-infant separation only at bedtime ("bedtime checking"), in comparison to an intervention that also directly targets night-wakings ("standard checking"/"graduated extinction").
详细描述
Early-childhood insomnia is very prevalent and is associated with negative child and family outcomes. Behavioral interventions, based on limiting parent-child nocturnal interactions, are effective in significantly improving infant sleep. However, these interventions frequently involve significant parent and infant distress that deter many parents. Research on gradual sleep interventions that involve a lower "dose" of parent-infant separation, and thus may be more accepted by many parents, has so far been sparse. Moreover, little scientific attention has been paid to factors that may underlie parental compliance with behavioral sleep interventions and treatment outcomes. Accordingly, the main aim of the proposed study is to study the processes through which parent and infant factors impact treatment adherence and outcomes of a behavioral intervention method that involves parent-infant separation only at bedtime ("bedtime checking"), compared to a method that also targets night-wakings ("standard checking"). The investigators will recruit 270 infants with early-childhood insomnia and their parents. Following a baseline assessment, infants will be randomly assigned to the "bedtime checking" intervention or to "standard checking". Within this total enrollment, a wait-list control group (WL-CTRL) of 40 families will be added starting in May 2026. These families will remain without intervention for 5 weeks, at which point they will only complete an infant sleep questionnaire. After this 5-week assessment, families will be briefed on both study interventions and may choose which one they would like to implement. Sleep assessment will include actigraphy, videosomnography, and sleep logs. Parents will complete baseline procedures and questionnaires to assess intervention moderators (e.g., parental emotional distress, infant temperament). Daily diaries will be used to assess predictors/mediators of treatment adherence and outcomes (e.g., parental stress, couple support). Assessments will be conducted during the intervention, and at 4 weeks, 6-months and 12-months post-treatment. The main hypotheses are: (1a) Compared with the WL-CTRL, "Bedtime checking" and Standard checking" will results in improved infant sleep outcomes (e.g., reduced number and length of night-wakings). (1b) For parents who adhere to their intervention, the "standard checking" method will obtain sleep outcomes more quickly; (1c) The "bedtime checking" method will lead to higher parental adherence and lower attrition, compared to "standard checking"; (2) Significant interactions between baseline parent/infant risk characteristics and type of intervention would be found in the prediction of sleep outcomes; (3) In both groups, higher adherence to the intervention and better sleep outcomes will be predicted by: (i) lower parental stress, guilt, and distress attributions, and (ii) higher perceived couple support; By systematically studying, for the first time, the "bedtime checking" method (that probably will be more acceptable to many parents), compared to "standard checking", findings promise to shed light on theory-based mediators and moderators through which behavioral sleep interventions might exercise their benefits.
研究者
Liat Tikotzky
Professor
Ben-Gurion University of the Negev
入排标准
入选标准
- •Early-childhood insomnia according to DSM-5 criteria
- •The parents wish to sleep independently from the child and would like the infant to need as little help as possible to fall asleep or stay asleep
- •Two-parent, Hebrew-speaking families.
- •Infants born at term (gestational age \> 36 weeks)
排除标准
- •Infants and parents with significant physiological sleep problems (e.g., sleep apnea)
- •Infants and parents with any chronic health problems (based on self-report).
研究组 & 干预措施
bedtime checking
The intervention is based on the principles of graduated extinction, defined as an "effective and recommended therapy in the treatment of bedtime problems and night-wakings" by the AASM. The basic guidelines for this intervention are: (1) When the infant shows tired signs, he/she should be put to bed awake; (2) parents should minimize their involvement after putting the infant to bed; (3) if the child protests/cries, the parent should check the infant's crib every few minutes (e.g., 5 minutes), briefly comfort the infant without taking him/her out of the crib, and help the infant resume a sleeping position/find sleep aids (e.g., pacifier); (4) disengage and leave the crib until the next visit, (5) In order to increase consistency, the same parent should implement the intervention. In the "bedtime checking" arm, parents will be instructed to implement the changes only at bedtime and will be asked to continue soothing their infant at night, as they normally do
干预措施: bedtime intervention for early childhood insomnia
standard checking
Same as for "bedtime checking" at bedtime, but in the standard checking arm, parents apply the intervention guidelines also when the infant wakes up during the night.
干预措施: bedtime and nighttime intervention for early childhood insomnia
Wait-list control group (WL-CTRL)
Participants in this arm are placed on a wait-list for 5 weeks. During this period, they receive no active intervention but complete all baseline assessments. At the 5-week follow-up (from baseline), these families only complete an infant sleep questionnaire (The Brief Infant Sleep Questionnaire) to serve as a control comparison for the primary outcomes. Following this assessment, the wait-list period concludes; families will receive a detailed explanation regarding both the "bedtime checking" and "standard checking" interventions and will be given the opportunity to choose between them for their own use.
结局指标
主要结局
Change in infant actigraphic number of night-wakings from baseline to 1-week and 2-week start of intervention
时间窗: baseline and 1- and 2-week start of intervention
Actigraphy, a wristwatch-like device, is a reliable method for measuring adults' and infants' sleep-wake patterns based on motility. The Sadeh validated scoring algorithms will be used to identify the number of night-wakings. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in the number of night-wakings but that standard checking would lead to a faster change than bedtime checking.
Change in parents' actigraphic minutes awake during the night from baseline to 1-week and 2-week start of intervention
时间窗: baseline and 1- and 2-week start of intervention
Actigraphy, a wristwatch-like device, is a reliable method for measuring adults' and infants' sleep-wake patterns based on motility. The Sadeh validated scoring algorithms will be used to identify nocturnal wakefulness according to a 1-minute epoch interval. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in minutes awake, but that standard checking would lead to a faster change than bedtime checking.
Change in parents' sleep logs' number of night-wakings from baseline to 1-week and 2-week start of intervention.
时间窗: baseline and 1- and 2-week start of intervention
Sleep logs have been validated relative to objective sleep measures, and they provide the parents' perspective on the infant and their own sleep. Parents will be asked to indicate each morning the number of times they woke up during the night. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in the number of night-wakings, but that standard checking would lead to a faster change than bedtime checking.
Change in parents' actigraphic number of night-wakings from baseline to 1-week and 2-week start of intervention
时间窗: baseline and 1- and 2-week start of intervention
Actigraphy, a wristwatch-like device, is a reliable method for measuring adults' and infants' sleep-wake patterns based on motility. The Sadeh validated scoring algorithms will be used to identify the number of night-wakings. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in the number of night-wakings but that standard checking would lead to a faster change than bedtime checking.
Change in infant sleep logs' minutes awake during the night from baseline to 1-week and 2-week start of intervention.
时间窗: baseline and 1- and 2-week start of intervention
Sleep logs have been validated relative to objective sleep measures, and they provide the parents' perspective on the infant and their own sleep. Parents will be asked to indicate each morning the length of time their infant was awake during the night. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in minutes awake, but that standard checking would lead to a faster change than bedtime checking.
Change in infant sleep logs' subjective sleep quality from baseline to 1-week and 2-week start of intervention.
时间窗: baseline and 1- and 2-week start of intervention
Parents will be asked to rate their infants' sleep quality on a scale ranging from 1 (bad) to 10 (excellent). Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to improved sleep quality, but that standard checking would lead to a faster change than bedtime checking.
Change in infant actigraphic minutes awake during the night from baseline to 1-week and 2-week start of intervention
时间窗: baseline and 1- and 2-week start of intervention
Actigraphy, a wristwatch-like device, is a reliable method for measuring adults' and infants' sleep-wake patterns based on motility. The Sadeh validated scoring algorithms will be used to identify nocturnal wakefulness according to a 1-minute epoch interval. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in minutes awake, but that standard checking would lead to a faster change than bedtime checking.
Change in parents' sleep logs' subjective sleep quality from baseline to 1-week and 2-week start of intervention.
时间窗: baseline and 1- and 2-week start of intervention
Parents will be asked to rate their own sleep quality on a scale ranging from 1 (bad) to 10 (excellent). Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to improved sleep quality, but that standard checking would lead to a faster change than bedtime checking.
Change in infant sleep logs' number of night-wakings from baseline to 1-week and 2-week start of intervention.
时间窗: baseline and 1- and 2-week start of intervention
Sleep logs have been validated relative to objective sleep measures, and they provide the parents' perspective on the infant and their own sleep. Parents will be asked to indicate each morning the number of times their infant woke up during the night. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in the number of night-wakings, but that standard checking would lead to a faster change than bedtime checking.
Attrition from intervention
时间窗: baseline and 2-week start of intervention.
The number of parents who drop out from the intervention. Change will be examined from baseline to end of the two-week intervention to examine the hypothesis that attrition from standard checking will be higher than from bedtime checking.
Change in parents' sleep logs' minutes awake during the night from baseline to 1-week and 2-week start of intervention.
时间窗: baseline and 1- and 2-week start of intervention
Sleep logs have been validated relative to objective sleep measures, and they provide the parents' perspective on the infant and their own sleep. Parents will be asked to indicate each morning the length of time they were awake during the night. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in minutes awake, but that standard checking would lead to a faster change than bedtime checking.
Change from Baseline in parental reports of Infant Sleep Quality (based on the BISQ)
时间窗: Baseline and 5 weeks post-baseline
To test the hypothesis that 'Bedtime checking' and 'Standard checking' will result in improved infant-parent sleep outcomes compared with the WL-CTRL, baseline BISQ variables (i.e., number and length of night-wakings, sleep latency, and perceived sleep problems) will be compared to the 5-week follow-up assessments across all groups. For the intervention arms, this corresponds to 3 weeks post-intervention; for the Wait-list Control, this corresponds to 5 weeks post-baseline.
次要结局
- Change in infant observed sleep duration from baseline to 2-week start of intervention.(baseline and 2-week start of intervention.)
- Adherence with intervention guidelines based on daily logs.(Measured daily during the two week intervention.)
- Change in infant actigraphic sleep duration from baseline to 2-week start of intervention(baseline and 2-week start of intervention.)
- Change in infant sleep-logs' sleep duration from baseline to 2-week start of intervention(baseline and 2-week start of intervention.)
- Change in parents' actigraphic sleep duration from baseline to 2-week start of intervention(baseline and 2-week start of intervention.)
- Change in parents' actigraphic longest sleep period from baseline to 2-week start of intervention.(baseline and 2-week start of intervention.)
- Change in infant observed number of night-wakings from baseline to 2-week start of intervention(baseline and 2-week start of intervention.)
- Change in infant observed sleep latency from baseline to 2-week start of intervention.(baseline and 2-week start of intervention.)
- Change in infant observed minutes awake during the night from baseline to 2-week start of intervention(baseline and 2-week start of intervention.)
- Adherence with intervention guidelines - interval from infant crying to parental approach(Measured daily during the two week intervention.)
- Adherence with intervention guidelines - total time of parental presence in infant room(Measured daily during the two week intervention.)
- Change in infant sleep logs' sleep latency from baseline to 2-week start of intervention(baseline and 2-week start of intervention.)
- Change in infant actigraphic longest sleep period from baseline to 2-week start of intervention.(baseline and 2-week start of intervention.)
- Change in infant observed nocturnal self-soothing behavior from start of intervention to end of intervention.(First 3 days of intervention and last 3 days of intervention)
- Change in parent actigraphic number of night-wakings from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.(baseline and 4 weeks, 6 months, 12 months post intervention.)
- Change in infant daily logs' number of night-wakings from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.(baseline and 4 weeks, 6 months, 12 months post intervention.)
- Change in parents' subjective rating of the infant's sleep problem from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.(baseline and 4 weeks, 6 months, 12 months post intervention.)
- Change in parents' sleep-logs' sleep duration from baseline to 2-week start of intervention(baseline and 2-week start of intervention.)
- Change in infant observed nocturnal self-soothing behavior (i.e., signaled night wakings out of total awakenings) from start of intervention to end of intervention.(First 3 days of intervention and last 3 days of intervention)
- Change in infant actigraphic number of night-wakings from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.(baseline and 4 weeks, 6 months, 12 months post intervention.)
- Change in parent actigraphic minutes awake during the night from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.(baseline and 4 weeks, 6 months, 12 months post intervention.)
- Adherence with intervention guidelines - type of parental help.(Measured daily during the two week intervention.)
- Change in infant actigraphic minutes awake during the night from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.(baseline and 4 weeks, 6 months, 12 months post intervention.)
- Change in infant daily logs' minutes awake during the night from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.(baseline and 4 weeks, 6 months, 12 months post intervention.)
- Change in parent daily logs' number of night-wakings from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.(baseline and 4 weeks, 6 months, 12 months post intervention.)
- Change in parent daily logs' minutes awake during the night from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.(baseline and 4 weeks, 6 months, 12 months post intervention.)
- Change in infant actigraphic number of night-wakings from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.(baseline and 3 weeks, 6 months, 12 months post intervention.)
- Change in parent actigraphic number of night-wakings from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.(baseline and 3 weeks, 6 months, 12 months post intervention.)
- Change in infant actigraphic minutes awake during the night from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.(baseline and 3 weeks, 6 months, 12 months post intervention.)
- Change in parent actigraphic minutes awake during the night from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.(Baseline and 3 weeks, 6 months, 12 months post intervention.)
- Change in infant daily logs' number of night-wakings from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.(Baseline and 3 weeks, 6 months, 12 months post intervention.)
- Change in parent daily logs' number of night-wakings from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.(Baseline and 3 weeks, 6 months, 12 months post intervention.)
- Change in infant daily logs' minutes awake during the night from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.(Baseline and 3 weeks, 6 months, 12 months post intervention.)
- Change in parent daily logs' minutes awake during the night from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.(Baseline and 3 weeks, 6 months, 12 months post intervention.)
- Change in parents' subjective rating of the infant's sleep problem from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.(baseline and 3 weeks, 6 months, 12 months post intervention.)