Interventions for Sleep Problems in Early Childhood

Sleep Disorder Clinical Trial

Official title:

Interventions for Sleep Problems in Early Childhood:The Role of Child, Parental and Intervention Factors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01489215
• Other study ID #: TASMC-11-YS-0522-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 8, 2011
• Last updated: December 8, 2011
• Start date: February 2012

Study information

• Verified date: December 2011
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Avi Sadeh, Prof.
• Phone: 03-6409296
• Email: sadeh[@]post.tau.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Months to 18 Months

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disorder
• Sleep Disorders

Intervention

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.
• "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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Israel Science Foundation, U.S. National Science Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved infant sleep	Less parental involvement in falling asleep, less night wakings, heightened sleep efficacy	base line to one month follow-up	No
Secondary	improvement in infant emotion regulation and in parent-infant interaction	infant heightened ability to regulate emotion when frustrated, a more secure infant attachment to mother, less infant withdrawal and more maternal sensitivity	one month follow-up to one year follow-up	No