Examining the Effectiveness of Two Behavioral Interventions for Sleep Problems in Infants
ConditionInsomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-18
SponsorBen-Gurion University of the Negev
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Infants and parents with significant physiological sleep problems (e.g., sleep apnea)
Infants and parents with any chronic health problems (based on self-report).
Trial design
Design model
Parallel
Treatments tested in this trial
bedtime intervention for early childhood insomnia
BehavioralThe 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
BehavioralThe 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.
Treatment groups
270 Participants
are divided into 3 treatment groupsGroup A: bedtime checkingExperimental treatment 1 intervention
Group B: standard checkingActive comparator 1 intervention
Group C: Wait-list control group (WL-CTRL)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in infant actigraphic number of night-wakings from baseline to 1-week 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.
Time frame
baseline and 1- and 2-week start of intervention2
Change in parents' actigraphic number of night-wakings from baseline to 1-week 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.
Time frame
baseline and 1- and 2-week start of intervention3
Change in infant actigraphic minutes awake during the night from baseline to 1-week 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.
Time frame
baseline and 1- and 2-week start of intervention4
Change in parents' actigraphic minutes awake during the night from baseline to 1-week 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.
Time frame
baseline and 1- and 2-week start of interventionSecondary outcomes
1
Change in infant sleep logs' sleep latency from baseline to 2-week start of intervention
Parents will indicate how long it took their infant to fall asleep.
Time frame
baseline and 2-week start of intervention.2
Change in infant actigraphic sleep duration from baseline to 2-week start of intervention
Actigraphy will be used to measure the number of true sleep minutes (excluding nighttime wakefulness) from sleep onset to morning awakenings.
Time frame
baseline and 2-week start of intervention.3
Change in infant sleep-logs' sleep duration from baseline to 2-week start of intervention
Parents will indicate the number of hours their infant slept (excluding nighttime wakefulness).
Time frame
baseline and 2-week start of intervention.4
Change in parents' actigraphic sleep duration from baseline to 2-week start of intervention
Actigraphy will be used to measure the number of true sleep minutes (excluding nighttime wakefulness) from sleep onset to morning awakenings.
Time frame
baseline and 2-week start of intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov