Interventions for Sleep Problems in Early Childhood

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Sleep Disorder

Treatments: Behavioral: "checking"; Behavioral: "presence"

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01489215

TASMC-11-YS-0522-CTIL

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 9 to 18 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Clinical group-"presence" intervention

Experimental group

Description:

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.

Treatment:

Behavioral: "presence"

Clinical group-"checking" intervention

Experimental group

Description:

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

Treatment:

Behavioral: "checking"

Control Group

No Intervention group