Back to resultsInterventions for Sleep Problems in Early Childhood
Primary Purpose
Sleep Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
"presence"
"checking"
Sponsored by
About this trial
This is an interventional basic science trial for Sleep Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Infants not meeting the inclusion criteria at the baseline assessment will be excluded from the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Clinical group-"presence" intervention
Clinical group-"checking" intervention
Control Group
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Improved infant sleep
Less parental involvement in falling asleep, less night wakings, heightened sleep efficacy
Secondary Outcome Measures
improvement in infant emotion regulation and in parent-infant interaction
infant heightened ability to regulate emotion when frustrated, a more secure infant attachment to mother, less infant withdrawal and more maternal sensitivity
Full Information
NCT ID
NCT01489215
First Posted
December 8, 2011
Last Updated
December 8, 2011
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Israel Science Foundation, U.S. National Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01489215
Brief Title
Interventions for Sleep Problems in Early Childhood
Official Title
Interventions for Sleep Problems in Early Childhood:The Role of Child, Parental and Intervention Factors
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Israel Science Foundation, U.S. National Science Foundation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clinical group-"presence" intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Clinical group-"checking" intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
"presence"
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
"checking"
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improved infant sleep
Description
Less parental involvement in falling asleep, less night wakings, heightened sleep efficacy
Time Frame
base line to one month follow-up
Secondary Outcome Measure Information:
Title
improvement in infant emotion regulation and in parent-infant interaction
Description
infant heightened ability to regulate emotion when frustrated, a more secure infant attachment to mother, less infant withdrawal and more maternal sensitivity
Time Frame
one month follow-up to one year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Infants not meeting the inclusion criteria at the baseline assessment will be excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avi Sadeh, Prof.
Phone
03-6409296
Email
sadeh@post.tau.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yakov Sivan, Prof.
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
32279703
Citation
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.
Results Reference
derived
PubMed Identifier
31676910
Citation
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.
Results Reference
derived
Learn more about this trial
Interventions for Sleep Problems in Early Childhood
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