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

NCT05726890 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2026-04-15

No results posted yet for this study

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").

Conditions

Interventions

BEHAVIORAL

bedtime intervention for early childhood insomnia

The intervention focuses on providing parents with skills on how to modify and limit their sleep-related interactions with their infant at bedtime. These changes are expected to foster the infant's ability to fall asleep independently at bedtime. It is also expected that after 1-2 weeks, these changes would lead to self-soothing also during the night. \*Also provided to wait-list control participants upon request after their 5-week control assessment

BEHAVIORAL

bedtime and nighttime intervention for early childhood insomnia

The intervention focuses on providing parents with skills on how to modify and limit their sleep-related interactions with their infant at bedtime and during the night. These changes are expected to foster the infant's ability to fall asleep independently at bedtime and to resume sleep independently during the night. \*Also provided to wait-list control participants upon request after their 5-week control assessment.

Sponsors & Collaborators

  • Ben-Gurion University of the Negev

    lead OTHER

Principal Investigators

  • Liat Tikotzky, PhD · Ben-Gurion University of the Negev

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-09
Primary Completion
2027-12-30
Completion
2028-09-30

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05726890 on ClinicalTrials.gov