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

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").

NCT Number	NCT05726890
Lead Sponsor	Ben-Gurion University of the Negev
Conditions	Insomnia
Enrollment	270 participants
Start Date	2023-03-09
Primary Completion	2027-12-30 (estimated)
Study Completion	2028-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-15