[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596659":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":24,"centralContacts":35,"locations":45,"responsibleParty":65,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":24,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Tel Aviv University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"CBT-I","EXPERIMENTAL","Families will receive the complete Cognitive Behavioral Therapy for Insomnia protocol (intake session + 4 CBT-I sessions).",[13],"Behavioral: Cognitive Behavioral Therapy for Insomnia",{"label":15,"type":16,"description":17,"interventionNames":18},"CBT-I without SRT","ACTIVE_COMPARATOR","Families will receive the Cognitive Behavioral Therapy for Insomnia protocol (intake session + 4 CBT-I sessions), excluding the Sleep Restriction Therapy (SRT) components.",[19],"Behavioral: Cognitive Behavioral Therapy for Insomnia without SRT",{"label":21,"type":22,"description":23,"interventionNames":24},"Waitlist control","NO_INTERVENTION","Families will complete the intake session and then be placed on a waitlist and receive CBT-I 5 weeks after baseline.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"BEHAVIORAL","Cognitive Behavioral Therapy for Insomnia","CBT-I intervention will include four 45-60 minute sessions with a clinician. The sessions will include CBT-I components such as sleep psychoeducation, bedtime routines and sleep hygiene, graduated exposure, cognitive restructuring, and SRT in one of the intervention groups. The protocol is based on previous studies of CBT-I for school-aged children.",[9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":24},"Cognitive Behavioral Therapy for Insomnia without SRT","This intervention will include four 45-60 minute sessions with a clinician. The sessions will include CBT-I components such as sleep psychoeducation, bedtime routines and sleep hygiene, graduated exposure, and cognitive restructuring. Sleep Restriction Therapy will not be included in the intervention. The protocol is based on previous studies that delivered CBT-I to school-aged children.",[15],[36,41],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":40},"Michal Kahn, PhD","CONTACT","+972544682588","michalkahn10@gmail.com",{"name":42,"role":38,"phone":43,"phoneExt":24,"email":44},"Shai Nimrodi, MA","058-426-6060","shainimrodi@gmail.com",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":49,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Tel Aviv","Israel","4641729","IL",{"type":53,"coordinates":54},"Point",[55,56],34.78057,32.08088,{"lat":56,"lon":55},[59,61,63],{"name":37,"role":38,"phone":60,"phoneExt":24,"email":40},"+972-544682588",{"name":42,"role":38,"phone":62,"phoneExt":24,"email":44},"=972-58-426-6060",{"name":37,"role":64,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Michal Kahn","Senior lecturer",[69],{"name":70,"class":6},"Israel Science Foundation","100596659","cognitive-behavioral-therapy-for-insomnia-in-school-aged-children-100596659",false,"NCT07048340","Cognitive-behavioral Therapy for Insomnia in School-aged Children","The Role of Sleep Restriction Therapy in Cognitive-behavioral Therapy for Insomnia in School-aged Children: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Child aged 7-11 years\n* Parents aged over 18 years\n* Child meets the International Classification of Sleep Disorders - Third Edition (ICSD-3) criteria for chronic insomnia disorder with sleep difficulties occurring at least 3 times a week and lasting at least 3 months (Insomnia diagnosis will be determined during a clinical interview).\n\nExclusion Criteria:\n\n* Child receiving concurrent CBT treatment for sleep or anxiety disorders.\n* Child diagnosed with a medical sleep problem (e.g., OSA, RLS)\n* Significant health or neurodevelopmental problems (e.g., intellectual disability)\n* Current psychotropic medications, or sleep aid medications\n* Lack of Hebrew reading and writing\n* Total sleep time that is shorter than 6 hours on average per night at baseline","ALL","7 Years","11 Years",{"count":82,"type":83},120,"ESTIMATED","INTERVENTIONAL",[86],"NA","This randomized controlled trial will test the efficacy of CBT-I intervention for school-aged children (7-11 years old) with insomnia. The trial will focus on the role of sleep restriction therapy in treatment. Children will be randomized to one of three groups: (1) CBT-I; (2) CBT-I without SRT; or (3) a waitlist control group. Assessments will occur at baseline, mid-treatment, post-treatment, and a 3-month follow up. Some measures (e.g., child motivation) will also be assessed after each therapy session. Insomnia and sleep-wake patterns will be assessed objectively using actigraphy, and subjectively using sleep diaries, a clinical diagnostic interview, and questionnaires. Parent and child questionnaires will be administered to assess moderators and mediators of treatment outcomes.",[89],"Insomnia",[89,91,9],"Pediatric insomnia","2025-09-13",{"date":94,"type":95},"2025-09-18","ACTUAL",{"date":97,"type":95},"2025-07-10",{"date":99,"type":83},"2029-12-01",{"name":5,"class":6},1]