[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495108":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":65,"collaborators":24,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":24,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":24,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":50,"whyStopped":24,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Ben-Gurion University of the Negev","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"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\u002Fshe should be put to bed awake; (2) parents should minimize their involvement after putting the infant to bed; (3) if the child protests\u002Fcries, the parent should check the infant's crib every few minutes (e.g., 5 minutes), briefly comfort the infant without taking him\u002Fher out of the crib, and help the infant resume a sleeping position\u002Ffind 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.\n\nIn 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",[13],"Behavioral: bedtime intervention for early childhood insomnia",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Behavioral: bedtime and nighttime intervention for early childhood insomnia",{"label":21,"type":22,"description":23,"interventionNames":24},"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.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"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.\n\n\\*Also provided to wait-list control participants upon request after their 5-week control assessment",[9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":24},"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.\n\n\\*Also provided to wait-list control participants upon request after their 5-week control assessment.",[15],[36],{"name":37,"affiliation":5,"role":38},"Liat Tikotzky, PhD","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":24,"email":43},"CONTACT","+972545497243","liatti@bgu.ac.il",{"name":45,"role":41,"phone":46,"phoneExt":24,"email":47},"Amit Samet, MA","+972546883467","amitsamet114@gmail.com",[49],{"facility":5,"status":50,"city":51,"state":24,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Beersheba","8410501","Israel","IL",{"type":56,"coordinates":57},"Point",[58,59],34.7913,31.25181,{"lat":59,"lon":58},[62,64],{"name":63,"role":41,"phone":42,"phoneExt":24,"email":43},"Liat Tikotזky, PיD",{"name":45,"role":41,"phone":46,"phoneExt":24,"email":47},{"type":38,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Liat Tikotzky","Professor","100495108","examining-the-effectiveness-of-two-behavioral-interventions-for-sleep-problems-in-infants-100495108",false,"NCT05726890","Examining the Effectiveness of Two Behavioral Interventions for Sleep Problems in Infants","Early Childhood Insomnia: Underlying Mechanisms of Intervention Effects of the \"Bedtime Checking\" and the \"Standard Checking\" Methods","Inclusion Criteria:\n\n* Early-childhood insomnia according to DSM-5 criteria\n* 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\n* Two-parent, Hebrew-speaking families.\n* Infants born at term (gestational age \\> 36 weeks)\n\nExclusion Criteria:\n\n* Infants and parents with significant physiological sleep problems (e.g., sleep apnea)\n* Infants and parents with any chronic health problems (based on self-report).","ALL","9 Months","18 Months",{"count":79,"type":80},270,"ESTIMATED","INTERVENTIONAL",[83],"NA","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\"\u002F\"graduated extinction\").",[86],"Insomnia",[88,89,90,91,92],"sleep","early childhood insomnia","infant","parent","behavioral sleep interventions","2026-04-12",{"date":95,"type":96},"2026-04-15","ACTUAL",{"date":98,"type":96},"2023-03-09",{"date":100,"type":80},"2028-09-30",{"name":5,"class":6},1]