Interventions for Sleep Problems in Early Childhood

Not Applicable

• Conditions: Sleep Disorder

• 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

Study Timeline

• Status Verified: 2011-12
• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-08
• Last Update Submitted: 2011-12-08
• Study First Posted: 2011-12-09
• Last Update Posted: 2011-12-09
• Study Start: 2012-02
• Primary Completion: 2015-02

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

Primary Outcome Measures

Name	Time	Method
Improved infant sleep	base line to one month follow-up	Less parental involvement in falling asleep, less night wakings, heightened sleep efficacy

Secondary Outcome Measures

Name	Time	Method
improvement in infant emotion regulation and in parent-infant interaction	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