Two bedtime methods for infants with sleep problems compared

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for infants with sleep problems (early-childhood insomnia) whose parents want the infant to fall asleep and stay asleep with little help.

Age

9 Months to 18 Months

Sex

All

Disease stage

Early-childhood insomnia according to DSM-5 criteria.

Main reasons for not taking part

• Infant or parent has a significant physical sleep problem, such as sleep apnea
• Infant or parent has any long-term health problem, as reported by the family
• Infant born at 36 weeks of pregnancy or earlier
• Families without two parents, or not Hebrew-speaking

The registry criteria, word for word

What the trial wants to find out

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").

The 3 groups in the trial

• bedtime checkingTreatment being tested

  The intervention is based on the principles of graduated extinction, defined as an "effective and recommended therapy in the treatment of bedtime problems and night-wakings" by the AASM. The basic guidelines for this intervention are: (1) When the infant shows tired signs, he/she should be put to bed awake; (2) parents should minimize their involvement after putting the infant to bed; (3) if the child protests/cries, the parent should check the infant's crib every few minutes (e.g., 5 minutes), briefly comfort the infant without taking him/her out of the crib, and help the infant resume a sleeping position/find sleep aids (e.g., pacifier); (4) disengage and leave the crib until the next visit, (5) In order to increase consistency, the same parent should implement the intervention. In the "bedtime checking" arm, parents will be instructed to implement the changes only at bedtime and will be asked to continue soothing their infant at night, as they normally do

  Treatment: bedtime intervention for early childhood insomnia

• standard checkingExisting treatment, for comparison

  Same as for "bedtime checking" at bedtime, but in the standard checking arm, parents apply the intervention guidelines also when the infant wakes up during the night.

  Treatment: bedtime and nighttime intervention for early childhood insomnia

• Wait-list control group (WL-CTRL)No study treatment, for comparison

  Participants in this arm are placed on a wait-list for 5 weeks. During this period, they receive no active intervention but complete all baseline assessments. At the 5-week follow-up (from baseline), these families only complete an infant sleep questionnaire (The Brief Infant Sleep Questionnaire) to serve as a control comparison for the primary outcomes. Following this assessment, the wait-list period concludes; families will receive a detailed explanation regarding both the "bedtime checking" and "standard checking" interventions and will be given the opportunity to choose between them for their own use.