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
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disorder||Behavioral: "presence" Behavioral: "checking"||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Interventions for Sleep Problems in Early Childhood:The Role of Child, Parental and Intervention Factors|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||February 2015|
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.
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.
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
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.
|No Intervention: Control Group|
- Improved infant sleep [ Time Frame: base line to one month follow-up ]Less parental involvement in falling asleep, less night wakings, heightened sleep efficacy
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489215
|Contact: Avi Sadeh, Prof.||firstname.lastname@example.org|
|Principal Investigator:||Yakov Sivan, Prof.||Tel-Aviv Sourasky Medical Center|