Interventions for Sleep Problems in Early Childhood:The Role of Child, Parental and Intervention Factors
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 180
- Primary Endpoint
- Improved infant sleep
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 9 Months to 18 Months (Child)
- Sex
- 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.
Arms & Interventions
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.
Intervention: "presence" (Behavioral)
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
Intervention: "checking" (Behavioral)
Control Group
Outcomes
Primary Outcomes
Improved infant sleep
Time Frame: base line to one month follow-up
Less parental involvement in falling asleep, less night wakings, heightened sleep efficacy
Secondary Outcomes
- improvement in infant emotion regulation and in parent-infant interaction(one month follow-up to one year follow-up)