Interventions for Sleep Problems in Early Childhood
1 other identifier
interventional
180
0 countries
N/A
Brief Summary
This study will inform the field about underlying mechanisms associated with infant sleep problems and will deepen the understanding of the intervention process. The study will provide detailed information on the intervention process itself and will explore how behavioral sleep interventions affect broader infant outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2011
CompletedFirst Posted
Study publicly available on registry
December 9, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedDecember 9, 2011
December 1, 2011
3 years
December 8, 2011
December 8, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Improved infant sleep
Less parental involvement in falling asleep, less night wakings, heightened sleep efficacy
base line to one month follow-up
Secondary Outcomes (1)
improvement in infant emotion regulation and in parent-infant interaction
one month follow-up to one year follow-up
Study Arms (3)
Clinical group-"presence" intervention
EXPERIMENTALThe "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.
Clinical group-"checking" intervention
EXPERIMENTALThe "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
Control Group
NO INTERVENTIONInterventions
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.
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
You may qualify if:
- infants at age range 9-18 months;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tel-Aviv Sourasky Medical Centerlead
- Israel Science Foundationcollaborator
- U.S. National Science Foundationcollaborator
Related Publications (2)
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.
PMID: 32279703DERIVEDKahn 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.
PMID: 31676910DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yakov Sivan, Prof.
Tel-Aviv Sourasky Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2011
First Posted
December 9, 2011
Study Start
February 1, 2012
Primary Completion
February 1, 2015
Last Updated
December 9, 2011
Record last verified: 2011-12