Insomnia Clinical Trials

Find Insomnia Clinical Trials Near You

Early Childhood Insomnia: Underlying Mechanisms of Intervention Effects of the Bedtime Checking and the Standard Checking Methods

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 9 months
Maximum Age: 1
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Israel
Ben-Gurion University of the Negev
RECRUITING
Beersheba
Contact Information
Primary
Liat Tikotzky, PhD
liatti@bgu.ac.il
+972545497243
Backup
Amit Samet, MA
amitsamet114@gmail.com
+972546883467
Time Frame
Start Date: 2023-03-09
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 270
Treatments
Experimental: bedtime checking
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
Active_comparator: standard checking
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.
No_intervention: Wait-list control group (WL-CTRL)
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.
Related Therapeutic Areas
Sponsors
Leads: Ben-Gurion University of the Negev

This content was sourced from clinicaltrials.gov

Similar Clinical Trials