- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01489215
Interventions for Sleep Problems in Early Childhood
December 8, 2011 updated by: Tel-Aviv Sourasky Medical Center
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Avi Sadeh, Prof.
- Phone Number: 03-6409296
- Email: sadeh@post.tau.ac.il
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
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
|
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
Time Frame: base line to one month follow-up
|
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
Time Frame: 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
|
one month follow-up to one year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yakov Sivan, Prof., Tel-Aviv Sourasky Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- TASMC-11-YS-0522-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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