Interventions for Sleep Problems in Early Childhood

Tel-Aviv Sourasky Medical Center180 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

180

Conditions

Sleep Disorder

Interventions

"presence"BEHAVIORAL

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.

"checking"BEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 9 MonthsMax age: 18 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Improved infant sleep

Less parental involvement in falling asleep, less night wakings, heightened sleep efficacy

Time frame: base line to one month follow-up

Secondary Outcomes

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

Time frame: one month follow-up to one year follow-up

Central Contacts

Avi Sadeh, Prof.

CONTACT

03-6409296 sadeh@post.tau.ac.il

Data from ClinicalTrials.gov

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