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

NCT05726890 | Recruiting

• 1 other identifier: 0276-22-SOR
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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").

Conditions

Insomnia

Keywords

sleep; early childhood insomnia; infant; parent; behavioral sleep interventions

Outcome Measures

Primary Outcomes (12)

• Change in infant actigraphic number of night-wakings from baseline to 1-week and 2-week start of intervention

  Actigraphy, a wristwatch-like device, is a reliable method for measuring adults' and infants' sleep-wake patterns based on motility. The Sadeh validated scoring algorithms will be used to identify the number of night-wakings. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in the number of night-wakings but that standard checking would lead to a faster change than bedtime checking.

  baseline and 1- and 2-week start of intervention

• Change in parents' actigraphic number of night-wakings from baseline to 1-week and 2-week start of intervention

  Actigraphy, a wristwatch-like device, is a reliable method for measuring adults' and infants' sleep-wake patterns based on motility. The Sadeh validated scoring algorithms will be used to identify the number of night-wakings. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in the number of night-wakings but that standard checking would lead to a faster change than bedtime checking.

  baseline and 1- and 2-week start of intervention

• Change in infant actigraphic minutes awake during the night from baseline to 1-week and 2-week start of intervention

  Actigraphy, a wristwatch-like device, is a reliable method for measuring adults' and infants' sleep-wake patterns based on motility. The Sadeh validated scoring algorithms will be used to identify nocturnal wakefulness according to a 1-minute epoch interval. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in minutes awake, but that standard checking would lead to a faster change than bedtime checking.

  baseline and 1- and 2-week start of intervention

• Change in parents' actigraphic minutes awake during the night from baseline to 1-week and 2-week start of intervention

  Actigraphy, a wristwatch-like device, is a reliable method for measuring adults' and infants' sleep-wake patterns based on motility. The Sadeh validated scoring algorithms will be used to identify nocturnal wakefulness according to a 1-minute epoch interval. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in minutes awake, but that standard checking would lead to a faster change than bedtime checking.

  baseline and 1- and 2-week start of intervention

• Change in infant sleep logs' number of night-wakings from baseline to 1-week and 2-week start of intervention.

  Sleep logs have been validated relative to objective sleep measures, and they provide the parents' perspective on the infant and their own sleep. Parents will be asked to indicate each morning the number of times their infant woke up during the night. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in the number of night-wakings, but that standard checking would lead to a faster change than bedtime checking.

  baseline and 1- and 2-week start of intervention

• Change in parents' sleep logs' number of night-wakings from baseline to 1-week and 2-week start of intervention.

  Sleep logs have been validated relative to objective sleep measures, and they provide the parents' perspective on the infant and their own sleep. Parents will be asked to indicate each morning the number of times they woke up during the night. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in the number of night-wakings, but that standard checking would lead to a faster change than bedtime checking.

  baseline and 1- and 2-week start of intervention

• Change in infant sleep logs' minutes awake during the night from baseline to 1-week and 2-week start of intervention.

  Sleep logs have been validated relative to objective sleep measures, and they provide the parents' perspective on the infant and their own sleep. Parents will be asked to indicate each morning the length of time their infant was awake during the night. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in minutes awake, but that standard checking would lead to a faster change than bedtime checking.

  baseline and 1- and 2-week start of intervention

• Change in parents' sleep logs' minutes awake during the night from baseline to 1-week and 2-week start of intervention.

  Sleep logs have been validated relative to objective sleep measures, and they provide the parents' perspective on the infant and their own sleep. Parents will be asked to indicate each morning the length of time they were awake during the night. Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to a reduction in minutes awake, but that standard checking would lead to a faster change than bedtime checking.

  baseline and 1- and 2-week start of intervention

• Change in infant sleep logs' subjective sleep quality from baseline to 1-week and 2-week start of intervention.

  Parents will be asked to rate their infants' sleep quality on a scale ranging from 1 (bad) to 10 (excellent). Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to improved sleep quality, but that standard checking would lead to a faster change than bedtime checking.

  baseline and 1- and 2-week start of intervention

• Change in parents' sleep logs' subjective sleep quality from baseline to 1-week and 2-week start of intervention.

  Parents will be asked to rate their own sleep quality on a scale ranging from 1 (bad) to 10 (excellent). Change will be examined from baseline to both 1-week and 2-week from start of intervention to examine the hypothesis that both interventions would lead to improved sleep quality, but that standard checking would lead to a faster change than bedtime checking.

  baseline and 1- and 2-week start of intervention

• Attrition from intervention

  The number of parents who drop out from the intervention. Change will be examined from baseline to end of the two-week intervention to examine the hypothesis that attrition from standard checking will be higher than from bedtime checking.

  baseline and 2-week start of intervention.

• Change from Baseline in parental reports of Infant Sleep Quality (based on the BISQ)

  To test the hypothesis that 'Bedtime checking' and 'Standard checking' will result in improved infant-parent sleep outcomes compared with the WL-CTRL, baseline BISQ variables (i.e., number and length of night-wakings, sleep latency, and perceived sleep problems) will be compared to the 5-week follow-up assessments across all groups. For the intervention arms, this corresponds to 3 weeks post-intervention; for the Wait-list Control, this corresponds to 5 weeks post-baseline.

  Baseline and 5 weeks post-baseline

Secondary Outcomes (26)

• Change in infant sleep logs' sleep latency from baseline to 2-week start of intervention

  baseline and 2-week start of intervention.

• Change in infant actigraphic sleep duration from baseline to 2-week start of intervention

  baseline and 2-week start of intervention.

• Change in infant sleep-logs' sleep duration from baseline to 2-week start of intervention

  baseline and 2-week start of intervention.

• Change in parents' actigraphic sleep duration from baseline to 2-week start of intervention

  baseline and 2-week start of intervention.

• Change in parents' sleep-logs' sleep duration from baseline to 2-week start of intervention

  baseline and 2-week start of intervention.

Study Arms (3)

bedtime checking

EXPERIMENTAL

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

Behavioral: bedtime intervention for early childhood insomnia

standard checking

ACTIVE COMPARATOR

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.

Behavioral: bedtime and nighttime intervention for early childhood insomnia

Wait-list control group (WL-CTRL)

NO INTERVENTION

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.

Interventions

bedtime intervention for early childhood insomnia 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. \*Also provided to wait-list control participants upon request after their 5-week control assessment

bedtime checking

bedtime and nighttime intervention for early childhood insomnia 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. \*Also provided to wait-list control participants upon request after their 5-week control assessment.

standard checking

Eligibility Criteria

• Age: 9 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Infants and parents with significant physiological sleep problems (e.g., sleep apnea)
• Infants and parents with any chronic health problems (based on self-report).

Sponsors & Collaborators

• Ben-Gurion University of the Negev: lead

Study Sites (1)

Ben-Gurion University of the Negev

Beersheba, 8410501, Israel

RECRUITING

Related Publications (7)

• 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.

  PMID: 17068979 BACKGROUND

• 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.

  PMID: 20620108 BACKGROUND

• 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.

  PMID: 24947271 BACKGROUND

• 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.

  PMID: 8034831 BACKGROUND

• 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.

  PMID: 14989452 BACKGROUND

• 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.

  PMID: 31676910 BACKGROUND

• 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.

  PMID: 27221288 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Liat Tikotzky, PhD

  Ben-Gurion University of the Negev

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liat Tikotzky, PhD

CONTACT

+972545497243; liatti@bgu.ac.il

Amit Samet, MA

CONTACT

+972546883467; amitsamet114@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Beginning May 2026, the study will transition to a three-arm parallel design. To incorporate the wait-list control group, the remaining 40 families will be allocated using a randomization ratio adjusted to prioritize the new control arm (1:1:1) until the total enrollment of 270 is reached.

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 14, 2023
• Study Start: March 9, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)