Examining two behavioral methods to improve sleep in infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of two behavioral interventions aimed at addressing insomnia in infants. It compares a 'bedtime checking' method, which involves minimal parent-infant separation at bedtime, to a 'standard checking' method that also addresses night-wakings. The study will recruit 230 infants diagnosed with early-childhood insomnia and their parents, assessing sleep through actigraphy, videosomnography, and sleep logs. Additionally, parental emotional distress and infant temperament will be evaluated to understand their impact on treatment outcomes.

Why it matters

Who can join: the full rules

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).

Where it's running

• Ben-Gurion University of the Negev
  Beersheba, Israel Recruiting

Study contacts

• Principal investigator: Liat Tikotzky, PhD — Ben-Gurion University of the Negev
• Study coordinator: Liat Tikotzky, PhD
• Email: liatti@bgu.ac.il
• Phone: +972545497243

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.