Examining the Effectiveness of Two Behavioral Interventions for Sleep Problems in Infants
Recruiting now · Not applicable
Conditions studied: Insomnia
In brief
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").
Key facts
- Study ID
- NCT05726890
- Run by
- Ben-Gurion University of the Negev
- People needed
- 270
- Starts
- 2023-03-09
- Expected to finish
- 2028-09-30
- Last updated by the study team
- 2026-04-15
Who can join
Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- Infants and parents with significant physiological sleep problems (e.g., sleep apnea)
- Infants and parents with any chronic health problems (based on self-report).
Where it is running
- Ben-Gurion University of the Negev — Beersheba, Israel (enrolling)
Full record on ClinicalTrials.gov
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