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Not Yet Recruiting NCT05726890

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

Conditions: Insomnia

Sex: All
Ages: 9 Months – 18 Months
Phase: NA
Enrollment: 230
Sponsor: Ben-Gurion University of the Negev

Location: Israel

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 Criteria

Inclusion Criteria:Early-childhood insomnia according to DSM-5 criteriaThe 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 asleepTwo-parent, Hebrew-speaking familiesExclusion Criteria: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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05726890). StuddyBuddy aggregates publicly available trial information.