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Interventions for Sleep Problems in Early Childhood

Not Applicable
Conditions
Sleep Disorder
Interventions
Behavioral: "presence"
Behavioral: "checking"
Registration Number
NCT01489215
Lead Sponsor
Tel-Aviv Sourasky Medical Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
180
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Clinical group-"presence" intervention"presence"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.
Clinical group-"checking" intervention"checking"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
Primary Outcome Measures
NameTimeMethod
Improved infant sleepbase line to one month follow-up

Less parental involvement in falling asleep, less night wakings, heightened sleep efficacy

Secondary Outcome Measures
NameTimeMethod
improvement in infant emotion regulation and in parent-infant interactionone 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

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