Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Clinical group-"presence" intervention
The "Presence" intervention is based on based on the principles of graduated extinction, which has been defined has been defined as "effective and recommended therapy in the treatment of bedtime problems and night wakings" by the Standard of Practice Committee of the American Academy of Sleep Medicine.
"presence"
constant presence of the parent in the child's room throughout the night during the first week of the intervention. In addition to sleeping near the child's crib, the parents repeat the same routines as in the "checking" method if the child is actively protesting or crying.
Clinical group-"checking" intervention
The "Checking" training is based on the principles of graduated extinction, which has been defined has been defined as "effective and recommended therapy in the treatment of bedtime problems and night wakings" by the Standard of Practice Committee of the American Academy of Sleep Medicine
"checking"
putting the child into the crib at bedtime and leaving the room with repeated quick visits every 5 minutes if the child is actively protesting or crying, providing brief reassurance, helping the child to resume a sleeping position.
Control Group
No interventions assigned to this group
Interventions
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"presence"
constant presence of the parent in the child's room throughout the night during the first week of the intervention. In addition to sleeping near the child's crib, the parents repeat the same routines as in the "checking" method if the child is actively protesting or crying.
"checking"
putting the child into the crib at bedtime and leaving the room with repeated quick visits every 5 minutes if the child is actively protesting or crying, providing brief reassurance, helping the child to resume a sleeping position.
Eligibility Criteria
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Inclusion Criteria
* healthy infants with no significant health problems;
* two-parents families;
* parents who master the Hebrew language.
* significant sleep problem lasting more than 3 months:
Our definition for a significant sleep problem in this age range is based on meeting at least one of the following three criteria for the baseline week:
* an average of three or more night-wakings per night;
* an average wake period of at least 30 minute per night between sleep onset and morning rise time;
* more than 30 minutes to fall asleep each night with protests for attention.
9 Months
18 Months
ALL
Yes
Sponsors
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Israel Science Foundation
OTHER
U.S. National Science Foundation
FED
Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Yakov Sivan, Prof.
Role: PRINCIPAL_INVESTIGATOR
Tel-Aviv Sourasky Medical Center
Central Contacts
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References
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Kahn M, Livne-Karp E, Juda-Hanael M, Omer H, Tikotzky L, Anders TF, Sadeh A. Behavioral interventions for infant sleep problems: the role of parental cry tolerance and sleep-related cognitions. J Clin Sleep Med. 2020 Aug 15;16(8):1275-1283. doi: 10.5664/jcsm.8488.
Kahn M, Juda-Hanael M, Livne-Karp E, Tikotzky L, Anders TF, Sadeh A. Behavioral interventions for pediatric insomnia: one treatment may not fit all. Sleep. 2020 Apr 15;43(4):zsz268. doi: 10.1093/sleep/zsz268.
Other Identifiers
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TASMC-11-YS-0522-CTIL
Identifier Type: -
Identifier Source: org_study_id