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Interventions for Sleep Problems in Early Childhood

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01489215
Enrollment
180
Registered
2011-12-09
Start date
2012-02-29
Completion date
Unknown
Last updated
2011-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorder

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.

Interventions

BEHAVIORALpresence

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.

BEHAVIORALchecking

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.

Sponsors

Israel Science Foundation
CollaboratorOTHER
U.S. National Science Foundation
CollaboratorFED
Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Months to 18 Months
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.

Design outcomes

Primary

MeasureTime frameDescription
Improved infant sleepbase line to one month follow-upLess parental involvement in falling asleep, less night wakings, heightened sleep efficacy

Secondary

MeasureTime frameDescription
improvement in infant emotion regulation and in parent-infant interactionone month follow-up to one year follow-upinfant heightened ability to regulate emotion when frustrated, a more secure infant attachment to mother, less infant withdrawal and more maternal sensitivity

Contacts

Primary ContactAvi Sadeh, Prof.
sadeh@post.tau.ac.il03-6409296

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026