RecruitingNot ApplicableNCT05726890

Examining the Effectiveness of Two Behavioral Interventions for Sleep Problems in Infants

Early Childhood Insomnia: Underlying Mechanisms of Intervention Effects of the "Bedtime Checking" and the "Standard Checking" Methods


Sponsor

Ben-Gurion University of the Negev

Enrollment

270 participants

Start Date

Mar 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Behavioral insomnia of childhood affects 15-30% of infants. Behavioral interventions, based on limiting parent-child bedtime and nighttime interactions, are effective in significantly improving infant sleep problems. However, the implementation of these interventions frequently encompasses significant infant crying and parental distress that deter many parents. Research on gradual sleep interventions that involve a lower "dose" of parent-infant separation, and thus may be more acceptable by parents, has so far been sparse. The proposed study aims to advance research in this area through systematically studying the processes through which parent and infant factors impact treatment outcomes of a behavioral intervention method that involves parent-infant separation only at bedtime ("bedtime checking"), in comparison to an intervention that also directly targets night-wakings ("standard checking"/"graduated extinction").


Eligibility

Min Age: 9 MonthsMax Age: 18 Months

Inclusion Criteria4

  • Early-childhood insomnia according to DSM-5 criteria
  • The parents wish to sleep independently from the child and would like the infant to need as little help as possible to fall asleep or stay asleep
  • Two-parent, Hebrew-speaking families.
  • Infants born at term (gestational age > 36 weeks)

Exclusion Criteria2

  • Infants and parents with significant physiological sleep problems (e.g., sleep apnea)
  • Infants and parents with any chronic health problems (based on self-report).

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Interventions

BEHAVIORALbedtime intervention for early childhood insomnia

The intervention focuses on providing parents with skills on how to modify and limit their sleep-related interactions with their infant at bedtime. These changes are expected to foster the infant's ability to fall asleep independently at bedtime. It is also expected that after 1-2 weeks, these changes would lead to self-soothing also during the night. \*Also provided to wait-list control participants upon request after their 5-week control assessment

BEHAVIORALbedtime and nighttime intervention for early childhood insomnia

The intervention focuses on providing parents with skills on how to modify and limit their sleep-related interactions with their infant at bedtime and during the night. These changes are expected to foster the infant's ability to fall asleep independently at bedtime and to resume sleep independently during the night. \*Also provided to wait-list control participants upon request after their 5-week control assessment.


Locations(1)

Ben-Gurion University of the Negev

Beersheba, Israel

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NCT05726890


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