Interventions for Sleep Problems in Early Childhood

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

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 Overview

• Status: Unknown
• Conditions: Sleep Disorder
• Intervention / Treatment: Behavioral: "presence"; Behavioral: "checking"

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
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.	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.
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	Behavioral: "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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: U.S. National Science Foundation; Israel Science Foundation
• Investigators: Principal Investigator: Yakov Sivan, Prof., Tel-Aviv Sourasky Medical Center

Publications and helpful links

General Publications

• Kahn M, Livne-Karp E, Juda-Hanael M, Omer H, Tikotzky L, Anders TF, Sadeh A. Behavioral interventions for infant sleep problems: the role of parental cry tolerance and sleep-related cognitions. J Clin Sleep Med. 2020 Aug 15;16(8):1275-1283. doi: 10.5664/jcsm.8488.
• Kahn M, Juda-Hanael M, Livne-Karp E, Tikotzky L, Anders TF, Sadeh A. Behavioral interventions for pediatric insomnia: one treatment may not fit all. Sleep. 2020 Apr 15;43(4):zsz268. doi: 10.1093/sleep/zsz268.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: December 8, 2011
• First Submitted That Met QC Criteria: December 8, 2011
• First Posted (Estimate): December 9, 2011

Study Record Updates

• Last Update Posted (Estimate): December 9, 2011
• Last Update Submitted That Met QC Criteria: December 8, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: TASMC-11-YS-0522-CTIL