Interventions for Sleep Problems in Early Childhood

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01489215

Collaborator

Israel Science Foundation (Other), U.S. National Science Foundation (U.S. Fed)

180

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorder	Behavioral: "presence" Behavioral: "checking"	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Feb 1, 2012

Anticipated Primary Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Months to 18 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT01489215

Other Study ID Numbers:

TASMC-11-YS-0522-CTIL

First Posted:

Dec 9, 2011

Last Update Posted:

Dec 9, 2011

Last Verified:

Dec 1, 2011

Additional relevant MeSH terms:

Sleep Wake Disorders

Parasomnias

Dyssomnias

Study Results

No Results Posted as of Dec 9, 2011