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

NCT ID: NCT05726890

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-09
• Study Completion Date: 2028-09-30

Brief 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").

Detailed Description

Early-childhood insomnia is very prevalent and is associated with negative child and family outcomes. Behavioral interventions, based on limiting parent-child nocturnal interactions, are effective in significantly improving infant sleep. However, these interventions frequently involve significant parent and infant distress that deter many parents. Research on gradual sleep interventions that involve a lower "dose" of parent-infant separation, and thus may be more accepted by many parents, has so far been sparse. Moreover, little scientific attention has been paid to factors that may underlie parental compliance with behavioral sleep interventions and treatment outcomes. Accordingly, the main aim of the proposed study is to study the processes through which parent and infant factors impact treatment adherence and outcomes of a behavioral intervention method that involves parent-infant separation only at bedtime ("bedtime checking"), compared to a method that also targets night-wakings ("standard checking").

The investigators will recruit 230 infants with early-childhood insomnia and their parents. Following a baseline assessment, infants will be randomly assigned to the "bedtime checking" intervention or to "standard checking". Sleep assessment will include actigraphy, videosomnography, and sleep logs. Parents will complete baseline procedures and questionnaires to assess intervention moderators (e.g., parental emotional distress, infant temperament). Daily diaries will be used to assess predictors/mediators of treatment adherence and outcomes (e.g., parental stress, couple support). Assessments will be conducted during the intervention, and at 4 weeks, 6-months and 12-months post-treatment.

The main hypotheses are: (1a) For parents who adhere to their intervention, the "standard checking" method will obtain sleep outcomes more quickly; (1b) The "bedtime checking" method will lead to higher parental adherence and lower attrition, compared to "standard checking"; (2) Significant interactions between baseline parent/infant risk characteristics and type of intervention would be found in the prediction of sleep outcomes; (3) In both groups, higher adherence to the intervention and better sleep outcomes will be predicted by: (i) lower parental stress, guilt, and distress attributions, and (ii) higher perceived couple support; By systematically studying, for the first time, the "bedtime checking" method (that probably will be more acceptable to many parents), compared to "standard checking", findings promise to shed light on theory-based mediators and moderators through which behavioral sleep interventions might exercise their benefits.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

bedtime intervention for early childhood insomnia

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

bedtime and nighttime intervention for early childhood insomnia

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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).

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ben-Gurion University of the Negev

OTHER

Sponsor Role: lead

Responsible Party

Liat Tikotzky

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liat Tikotzky, PhD

Role: PRINCIPAL_INVESTIGATOR

Ben-Gurion University of the Negev

Locations

Ben-Gurion University of the Negev

Beersheba, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Liat Tikotzky, PhD

Role: CONTACT

liatti@bgu.ac.il

+972545497243

Amit Samet, MA

Role: CONTACT

amitsamet114@gmail.com

+972546883467

Facility Contacts

Liat Tikotזky, PיD

Role: primary

liatti@bgu.ac.il

+972545497243

Amit Samet, MA

Role: backup

amitsamet114@gmail.com

+972546883467

References

Mindell JA, Kuhn B, Lewin DS, Meltzer LJ, Sadeh A; American Academy of Sleep Medicine. Behavioral treatment of bedtime problems and night wakings in infants and young children. Sleep. 2006 Oct;29(10):1263-76.

Reference Type: BACKGROUND

PMID: 17068979 (View on PubMed)

Tikotzky L, Sadeh A. The role of cognitive-behavioral therapy in behavioral childhood insomnia. Sleep Med. 2010 Aug;11(7):686-91. doi: 10.1016/j.sleep.2009.11.017.

Reference Type: BACKGROUND

PMID: 20620108 (View on PubMed)

Meltzer LJ, Mindell JA. Systematic review and meta-analysis of behavioral interventions for pediatric insomnia. J Pediatr Psychol. 2014 Sep;39(8):932-48. doi: 10.1093/jpepsy/jsu041. Epub 2014 Jun 19.

Reference Type: BACKGROUND

PMID: 24947271 (View on PubMed)

Sadeh A. Assessment of intervention for infant night waking: parental reports and activity-based home monitoring. J Consult Clin Psychol. 1994 Feb;62(1):63-8. doi: 10.1037//0022-006x.62.1.63.

Reference Type: BACKGROUND

PMID: 8034831 (View on PubMed)

Eckerberg B. Treatment of sleep problems in families with young children: effects of treatment on family well-being. Acta Paediatr. 2004 Jan;93(1):126-34. doi: 10.1080/08035250310007754.

Reference Type: BACKGROUND

PMID: 14989452 (View on PubMed)

Kahn M, Juda-Hanael M, Livne-Karp E, Tikotzky L, Anders TF, Sadeh A. Behavioral interventions for pediatric insomnia: one treatment may not fit all. Sleep. 2020 Apr 15;43(4):zsz268. doi: 10.1093/sleep/zsz268.

Reference Type: BACKGROUND

PMID: 31676910 (View on PubMed)

Gradisar M, Jackson K, Spurrier NJ, Gibson J, Whitham J, Williams AS, Dolby R, Kennaway DJ. Behavioral Interventions for Infant Sleep Problems: A Randomized Controlled Trial. Pediatrics. 2016 Jun;137(6):e20151486. doi: 10.1542/peds.2015-1486.

Reference Type: BACKGROUND

PMID: 27221288 (View on PubMed)

Other Identifiers

0276-22-SOR

Identifier Type: -

Identifier Source: org_study_id