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Interventions for Sleep Problems in Early Childhood

This study is not yet open for participant recruitment.
Verified December 2011 by Tel-Aviv Sourasky Medical Center
Sponsor:
Collaborators:
Israel Science Foundation
U.S. National Science Foundation
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01489215
First received: December 8, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Sleep Disorder
 Behavioral: "presence"
Behavioral: "checking"

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 180
Study Start Date: February 2012
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Control Group

  Eligibility

Ages Eligible for Study:   9 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489215

Contacts
Contact: Avi Sadeh, Prof. 03-6409296 sadeh@post.tau.ac.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Israel Science Foundation
U.S. National Science Foundation
Investigators
Principal Investigator: Yakov Sivan, Prof. Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01489215     History of Changes
Other Study ID Numbers: TASMC-11-YS-0522-CTIL
Study First Received: December 8, 2011
Last Updated: December 8, 2011
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Dyssomnias
Nervous System Diseases
 Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013