InsomniaNCT05726890
Examining the Effectiveness of Two Behavioral Interventions for Sleep Problems in Infants
A study testing bedtime intervention for early childhood insomnia and bedtime and nighttime intervention for early childhood insomnia in people with Insomnia, run by Ben-Gurion University of the Negev at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 18 months
- Conditions the study is for
- Insomnia
- What is being tested?
- bedtime intervention for early childhood insomnia and bedtime and nighttime intervention for early childhood insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Mar 2023to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Infants and parents with significant physiological sleep problems (e.g., sleep apnea)
- Infants and parents with any chronic health problems (based on self-report).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Ben-Gurion University of the Negev
Beersheba, 8410501
Liat Tikotזky, PיD, +972545497243, liatti@bgu.ac.il
Amit Samet, MA, +972546883467, amitsamet114@gmail.com
About this study
Official title: Early Childhood Insomnia: Underlying Mechanisms of Intervention Effects of the "Bedtime Checking" and the "Standard Checking" Methods
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").
Read the 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 270 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". Within this total enrollment, a wait-list control group (WL-CTRL) of 40 families will be added starting in May 2026. These families will remain without intervention for 5 weeks, at which point they will only complete an infant sleep questionnaire. After this 5-week assessment, families will be briefed on both study interventions and may choose which one they would like to implement.
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) Compared with the WL-CTRL, "Bedtime checking" and Standard checking" will results in improved infant sleep outcomes (e.g., reduced number and length of night-wakings). (1b) For parents who adhere to their intervention, the "standard checking" method will obtain sleep outcomes more quickly; (1c) 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
- Being tested
- bedtime intervention for early childhood insomnia, bedtime and nighttime intervention for early childhood insomnia
- Keywords
- sleep, early childhood insomnia, infant, parent, behavioral sleep interventions
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bedtime intervention for early childhood insomniaBehavioural
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 and nighttime intervention for early childhood insomniaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 5 weeks post-baseline
Secondary outcomes (26)
Change in infant sleep logs' sleep latency from baseline to 2-week start of intervention
Parents will indicate how long it took their infant to fall asleep.
Measured: baseline and 2-week start of intervention.
Change in infant actigraphic sleep duration from baseline to 2-week start of intervention
Actigraphy will be used to measure the number of true sleep minutes (excluding nighttime wakefulness) from sleep onset to morning awakenings.
Measured: baseline and 2-week start of intervention.
Change in infant sleep-logs' sleep duration from baseline to 2-week start of intervention
Parents will indicate the number of hours their infant slept (excluding nighttime wakefulness).
Measured: baseline and 2-week start of intervention.
Change in parents' actigraphic sleep duration from baseline to 2-week start of intervention
Actigraphy will be used to measure the number of true sleep minutes (excluding nighttime wakefulness) from sleep onset to morning awakenings.
Measured: baseline and 2-week start of intervention.
Change in parents' sleep-logs' sleep duration from baseline to 2-week start of intervention
Parents will indicate the number of hours they slept (excluding nighttime wakefulness).
Measured: baseline and 2-week start of intervention.
Change in infant actigraphic longest sleep period from baseline to 2-week start of intervention.
Actigraphy will be used to measure the longest sleep stretch during the night.
Measured: baseline and 2-week start of intervention.
Change in parents' actigraphic longest sleep period from baseline to 2-week start of intervention.
Actigraphy will be used to measure the longest sleep stretch during the night.
Measured: baseline and 2-week start of intervention.
Change in infant observed sleep latency from baseline to 2-week start of intervention.
Videosomnography will be used to assess the change in observed sleep latency. Scoring of sleep latency (a continuous variable) based on the video records will be based on established methods, developed by Thomas Anders. We consider these as secondary outcomes as we are not sure how many parents will be willing to use the cameras.
Measured: baseline and 2-week start of intervention.
Change in infant observed number of night-wakings from baseline to 2-week start of intervention
Videosomnography will be used to assess the change in observed number of night-wakings. Scoring of the number of awakenings (a continuous variable) based on the videos, will be based on established methods, developed by Thomas Anders.
Measured: baseline and 2-week start of intervention.
Change in infant observed minutes awake during the night from baseline to 2-week start of intervention
Videosomnography will be used to assess the change in observed minutes awake during the night. Scoring of minutes awake (a continuous variable) based on the video records will be based on established methods, developed by Thomas Anders.
Measured: baseline and 2-week start of intervention.
Change in infant observed sleep duration from baseline to 2-week start of intervention.
Videosomnography will be used to assess the change in observed sleep duration. Scoring of sleep duration (a continuous variable) based on the video records will be based on established methods, developed by Thomas Anders.
Measured: baseline and 2-week start of intervention.
Change in infant observed nocturnal self-soothing behavior (i.e., signaled night wakings out of total awakenings) from start of intervention to end of intervention.
Videosomnography will be used to observe the change in the number of times the infant wakes up and signals out of total number of wakings.
Measured: First 3 days of intervention and last 3 days of intervention
Change in infant observed nocturnal self-soothing behavior from start of intervention to end of intervention.
Videosomnography will be used to observe the change in the percent of infant self-soothing behaviors (e.g., looking for pacifier, use of comforting object) out of all soothing behaviors.
Measured: First 3 days of intervention and last 3 days of intervention
Adherence with intervention guidelines - interval from infant crying to parental approach
Videosomnography will be used to observe the interval from the time of infant signaling to the time the parent approaches the crib.
Measured: Measured daily during the two week intervention.
Adherence with intervention guidelines - total time of parental presence in infant room
Videosomnography will be used to observe the total time of parental presence in room as a response to infant cry.
Measured: Measured daily during the two week intervention.
Adherence with intervention guidelines - type of parental help.
Videosomnography will be used to observe the type of parental response (e.g., short visit as guided, prolonged visit with active help).
Measured: Measured daily during the two week intervention.
Adherence with intervention guidelines based on daily logs.
Parental daily logs will be employed to assess adherence using a scale from 1 (not at all) to 7 (very much). Parents in the bedtime checking group will report only in the evening. Parents in the standard checking group will report also in the morning regarding nighttime adherence.
Measured: Measured daily during the two week intervention.
Change in infant actigraphic number of night-wakings from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Actigraphy will be used to identify the number of night-wakings. Change will be examined from baseline to 3 weeks post intervention, and to 6 and 12 months post intervention.
Measured: baseline and 3 weeks, 6 months, 12 months post intervention.
Change in parent actigraphic number of night-wakings from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Actigraphy will be used to identify the number of night-wakings. Change will be examined from baseline to 3 weeks post intervention, and to 6 and 12 months post intervention.
Measured: baseline and 3 weeks, 6 months, 12 months post intervention.
Change in infant actigraphic minutes awake during the night from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Actigraphy will be used to identify minutes awake during the night. Change will be examined from baseline to 3 weeks post intervention, and to 6 and 12 months post intervention.
Measured: baseline and 3 weeks, 6 months, 12 months post intervention.
Change in parent actigraphic minutes awake during the night from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Actigraphy will be used to identify minutes awake during the night. Change will be examined from baseline to 3 weeks post intervention, and to 6 and 12 months post intervention.
Measured: Baseline and 3 weeks, 6 months, 12 months post intervention.
Change in infant daily logs' number of night-wakings from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Parents will use sleep logs to indicate each morning the number of times their infant woke up during the night. Change will be examined from baseline to 3 weeks post intervention, and to 6 and 12 months post intervention.
Measured: Baseline and 3 weeks, 6 months, 12 months post intervention.
Change in parent daily logs' number of night-wakings from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Parents will use sleep logs to indicate each morning the number of times they woke up during the night. Change will be examined from baseline to 3 weeks post intervention, and to 6 and 12 months post intervention.
Measured: Baseline and 3 weeks, 6 months, 12 months post intervention.
Change in infant daily logs' minutes awake during the night from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Parents will use sleep logs to indicate each morning how many minutes their infant was awake during the night. Change will be examined from baseline to 3 weeks post intervention, and to 6 and 12 months post intervention.
Measured: Baseline and 3 weeks, 6 months, 12 months post intervention.
Change in parent daily logs' minutes awake during the night from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Parents will use sleep logs to indicate each morning how many minutes they were awake during the night. Change will be examined from baseline to 3 weeks post intervention, and to 6 and 12 months post intervention.
Measured: Baseline and 3 weeks, 6 months, 12 months post intervention.
Change in parents' subjective rating of the infant's sleep problem from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Four item from the Brief Infant Sleep Questionnaire will be used to examine change in parental perception of their infant's sleep problems: (1) "Do you consider your child's sleep as a problem?":1= not at all to 5 = very much; (2) Number of night-wakings; (3) Length of night-wakings; (4) sleep latency
Measured: baseline and 3 weeks, 6 months, 12 months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start9 Mar 2023
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ben-Gurion University of the Negev
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liat Tikotzky, Ben-Gurion University of the Negev
- Investigators
- Liat Tikotzky, PhD, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726890
- Sponsor's protocol ID
- 0276-22-SOR
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will be kept confidential.
Publications
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.
PubMed 17068979Tikotzky 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.
PubMed 20620108Meltzer 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.
PubMed 24947271Sadeh 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.
PubMed 8034831Eckerberg 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.
PubMed 14989452Kahn 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.
PubMed 31676910Gradisar 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.
PubMed 27221288
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Childhood Insomnia: Underlying Mechanisms of Intervention Effects of the "Bedtime Checking" and the "Standard Checking" Methods
- ClinicalTrials.gov ID
- NCT05726890
- Acronym / sponsor ID
- 0276-22-SOR
- Conditions
- Insomnia
- Keywords
- sleep, early childhood insomnia, infant, parent, behavioral sleep interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Ben-Gurion University of the NegevUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 270 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". Within this total enrollment, a wait-list control group (WL-CTRL) of 40 families will be added starting in May 2026. These families will remain without intervention for 5 weeks, at which point they will only complete an infant sleep questionnaire. After this 5-week assessment, families will be briefed on both study interventions and may choose which one they would like to implement.
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) Compared with the WL-CTRL, "Bedtime checking" and Standard checking" will results in improved infant sleep outcomes (e.g., reduced number and length of night-wakings). (1b) For parents who adhere to their intervention, the "standard checking" method will obtain sleep outcomes more quickly; (1c) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| bedtime checking | Experimental | Behavioral: bedtime intervention for early childhood insomniaThe 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 |
| standard checking | Active comparator | Behavioral: bedtime and nighttime intervention for early childhood insomniaSame 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. |
| 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. |
Who may qualify
- Ages
- 9 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Infants and parents with significant physiological sleep problems (e.g., sleep apnea)
- Infants and parents with any chronic health problems (based on self-report).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bedtime intervention for early childhood insomniaThe 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 | Behavioural | bedtime checking |
| bedtime and nighttime intervention for early childhood insomniaThe 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. | Behavioural | standard checking |
Primary outcome
Change in infant actigraphic number of night-wakings from baseline to 1-week and 2-week start of intervention
Time frame: baseline and 1- 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.
Change in parents' actigraphic number of night-wakings from baseline to 1-week and 2-week start of intervention
Time frame: baseline and 1- 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.
Change in infant actigraphic minutes awake during the night from baseline to 1-week and 2-week start of intervention
Time frame: baseline and 1- 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.
Change in parents' actigraphic minutes awake during the night from baseline to 1-week and 2-week start of intervention
Time frame: baseline and 1- 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.
Change in infant sleep logs' number of night-wakings from baseline to 1-week and 2-week start of intervention.
Time frame: baseline and 1- 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.
Change in parents' sleep logs' number of night-wakings from baseline to 1-week and 2-week start of intervention.
Time frame: baseline and 1- 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.
Change in infant sleep logs' minutes awake during the night from baseline to 1-week and 2-week start of intervention.
Time frame: baseline and 1- 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.
Change in parents' sleep logs' minutes awake during the night from baseline to 1-week and 2-week start of intervention.
Time frame: baseline and 1- 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.
Change in infant sleep logs' subjective sleep quality from baseline to 1-week and 2-week start of intervention.
Time frame: baseline and 1- 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.
Change in parents' sleep logs' subjective sleep quality from baseline to 1-week and 2-week start of intervention.
Time frame: baseline and 1- 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.
Attrition from intervention
Time frame: baseline and 2-week start of 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.
Change from Baseline in parental reports of Infant Sleep Quality (based on the BISQ)
Time frame: Baseline and 5 weeks post-baseline
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.
26 secondary outcomes
Change in infant sleep logs' sleep latency from baseline to 2-week start of intervention
Time frame: baseline and 2-week start of intervention.
Change in infant actigraphic sleep duration from baseline to 2-week start of intervention
Time frame: baseline and 2-week start of intervention.
Change in infant sleep-logs' sleep duration from baseline to 2-week start of intervention
Time frame: baseline and 2-week start of intervention.
Change in parents' actigraphic sleep duration from baseline to 2-week start of intervention
Time frame: baseline and 2-week start of intervention.
Change in parents' sleep-logs' sleep duration from baseline to 2-week start of intervention
Time frame: baseline and 2-week start of intervention.
Change in infant actigraphic longest sleep period from baseline to 2-week start of intervention.
Time frame: baseline and 2-week start of intervention.
Change in parents' actigraphic longest sleep period from baseline to 2-week start of intervention.
Time frame: baseline and 2-week start of intervention.
Change in infant observed sleep latency from baseline to 2-week start of intervention.
Time frame: baseline and 2-week start of intervention.
Change in infant observed number of night-wakings from baseline to 2-week start of intervention
Time frame: baseline and 2-week start of intervention.
Change in infant observed minutes awake during the night from baseline to 2-week start of intervention
Time frame: baseline and 2-week start of intervention.
Change in infant observed sleep duration from baseline to 2-week start of intervention.
Time frame: baseline and 2-week start of intervention.
Change in infant observed nocturnal self-soothing behavior (i.e., signaled night wakings out of total awakenings) from start of intervention to end of intervention.
Time frame: First 3 days of intervention and last 3 days of intervention
Change in infant observed nocturnal self-soothing behavior from start of intervention to end of intervention.
Time frame: First 3 days of intervention and last 3 days of intervention
Adherence with intervention guidelines - interval from infant crying to parental approach
Time frame: Measured daily during the two week intervention.
Adherence with intervention guidelines - total time of parental presence in infant room
Time frame: Measured daily during the two week intervention.
Adherence with intervention guidelines - type of parental help.
Time frame: Measured daily during the two week intervention.
Adherence with intervention guidelines based on daily logs.
Time frame: Measured daily during the two week intervention.
Change in infant actigraphic number of night-wakings from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Time frame: baseline and 3 weeks, 6 months, 12 months post intervention.
Change in parent actigraphic number of night-wakings from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Time frame: baseline and 3 weeks, 6 months, 12 months post intervention.
Change in infant actigraphic minutes awake during the night from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Time frame: baseline and 3 weeks, 6 months, 12 months post intervention.
Change in parent actigraphic minutes awake during the night from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Time frame: Baseline and 3 weeks, 6 months, 12 months post intervention.
Change in infant daily logs' number of night-wakings from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Time frame: Baseline and 3 weeks, 6 months, 12 months post intervention.
Change in parent daily logs' number of night-wakings from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Time frame: Baseline and 3 weeks, 6 months, 12 months post intervention.
Change in infant daily logs' minutes awake during the night from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Time frame: Baseline and 3 weeks, 6 months, 12 months post intervention.
Change in parent daily logs' minutes awake during the night from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Time frame: Baseline and 3 weeks, 6 months, 12 months post intervention.
Change in parents' subjective rating of the infant's sleep problem from baseline to 3 weeks post intervention and to 6 and 12 months post intervention.
Time frame: baseline and 3 weeks, 6 months, 12 months post intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 17068979Mindell 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.
- Background: PubMed 20620108Tikotzky 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.
- Background: PubMed 24947271Meltzer 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.
- Background: PubMed 8034831Sadeh 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.
- Background: PubMed 14989452Eckerberg 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.
- Background: PubMed 31676910Kahn 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.
- Background: PubMed 27221288Gradisar 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.
- Individual participant dataSharing planned: No. Individual data will be kept confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liat Tikotzky, PhD principal investigator
Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bedtime intervention for early childhood insomnia and bedtime and nighttime intervention for early childhood insomnia in people with Insomnia, run by Ben-Gurion University of the Negev at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liat Tikotzky, PhD (+972545497243, liatti@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in infant actigraphic number of night-wakings from baseline to 1-week and 2-week start of intervention (time frame: baseline and 1- and 2-week start of intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05726890, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.