Interventions for Sleep Problems in Early Childhood
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Interventions for Sleep Problems in Early Childhood:The Role of Child, Parental and Intervention Factors|
- Improved infant sleep [ Time Frame: base line to one month follow-up ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]infant heightened ability to regulate emotion when frustrated, a more secure infant attachment to mother, less infant withdrawal and more maternal sensitivity
|Study Start Date:||February 2012|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489215
|Contact: Avi Sadeh, Prof.||firstname.lastname@example.org|
|Principal Investigator:||Yakov Sivan, Prof.||Tel-Aviv Sourasky Medical Center|