Interventions for Sleep Problems in Early Childhood

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep Disorder

Intervention / Treatment
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* Behavioral: presence
* Behavioral: checking


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical group-presence intervention<br>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<br>* 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.<br>|
| Experimental: Clinical group-checking intervention<br>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<br>* 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.<br>|
| No Intervention: Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved infant sleep | 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 | 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 |