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

RecruitingNAAges 9 Months - 18 MonthsAllBen-Gurion University of the Negev
NCT05726890 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 chec

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 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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What it tests

  • bedtime intervention for early childhood insomnia
  • bedtime and nighttime intervention for early childhood insomnia
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Where

1 site
Ben-Gurion University of the Negev
Beersheba, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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