Examining the Effectiveness of Two Behavioral Interventions for Sleep Problems in Infants

Condition(s) studied

Investigational drug(s) / intervention(s)

bedtime intervention for early childhood insomnia: The intervention focuses on providing parents with skills on how to modify and limit their sleep-related interactions with their infant at bedtime. These changes are expected to foster the infant's ability to fall asleep independently at bedtime. It is also expected that after 1-2 weeks, these changes would lead to self-soothing also during the night. \*Also provided to wait-list control participants upon request after their 5-week control assessment

bedtime and nighttime intervention for early childhood insomnia: The intervention focuses on providing parents with skills on how to modify and limit their sleep-related interactions with their infant at bedtime and during the night. These changes are expected to foster the infant's ability to fall asleep independently at bedtime and to resume sleep independently during the night. \*Also provided to wait-list control participants upon request after their 5-week control assessment.

Study summary

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").

Eligibility

Primary outcome measure(s)

• Change in infant actigraphic number of night-wakings from baseline to 1-week and 2-week start of intervention — 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 number of night-wakings from baseline to 1-week and 2-week start of intervention — 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 actigraphic minutes awake during the night from baseline to 1-week and 2-week start of intervention — 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' actigraphic minutes awake during the night from baseline to 1-week and 2-week start of intervention — 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 infant sleep logs' number of night-wakings from baseline to 1-week and 2-week start of intervention. — 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.
• Change in parents' sleep logs' number of night-wakings from baseline to 1-week and 2-week start of intervention. — 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 infant sleep logs' minutes awake during the night from baseline to 1-week and 2-week start of intervention. — 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 parents' sleep logs' minutes awake during the night from baseline to 1-week and 2-week start of intervention. — 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 in infant sleep logs' subjective sleep quality from baseline to 1-week and 2-week start of intervention. — 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 parents' sleep logs' subjective sleep quality from baseline to 1-week and 2-week start of intervention. — 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.
• Attrition from intervention — 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 from Baseline in parental reports of Infant Sleep Quality (based on the BISQ) — 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.

Trial sites (1)

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