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Interventions for Sleep Problems in Early Childhood

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ClinicalTrials.gov Identifier: NCT01489215
Recruitment Status : Unknown
Verified December 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 9, 2011
Last Update Posted : December 9, 2011
Sponsor:
Collaborators:
Israel Science Foundation
U.S. National Science Foundation
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

December 8, 2011
December 9, 2011
December 9, 2011
February 2012
February 2015   (Final data collection date for primary outcome measure)
Improved infant sleep [ Time Frame: base line to one month follow-up ]
Less parental involvement in falling asleep, less night wakings, heightened sleep efficacy
Same as current
No Changes Posted
improvement in infant emotion regulation and in parent-infant interaction [ Time Frame: one month follow-up to one year follow-up ]
infant heightened ability to regulate emotion when frustrated, a more secure infant attachment to mother, less infant withdrawal and more maternal sensitivity
Same as current
Not Provided
Not Provided
 
Interventions for Sleep Problems in Early Childhood
Interventions for Sleep Problems in Early Childhood:The Role of Child, Parental and Intervention Factors
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Sleep Disorder
  • Behavioral: "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.
  • Behavioral: "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.
  • Experimental: 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.
    Intervention: Behavioral: "presence"
  • Experimental: 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
    Intervention: Behavioral: "checking"
  • No Intervention: Control Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
180
Same as current
Not Provided
February 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
9 Months to 18 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01489215
TASMC-11-YS-0522-CTIL
Not Provided
Not Provided
Not Provided
Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
  • Israel Science Foundation
  • U.S. National Science Foundation
Principal Investigator: Yakov Sivan, Prof. Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP