[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100415762":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":33,"centralContacts":40,"locations":48,"responsibleParty":86,"collaborators":24,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":24,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":24,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":51,"whyStopped":24,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"UConn Health","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Child Anxiety Learning Modules (CALM)","EXPERIMENTAL","Children randomly assigned to this condition will receive the CALM intervention.",[13],"Behavioral: Child Anxiety Learning Modules (CALM)",{"label":15,"type":16,"description":17,"interventionNames":18},"Child Anxiety Learning Modules--Relaxation (CALM-R)","ACTIVE_COMPARATOR","Children randomly assigned to this condition will receive the CALM-R intervention.",[19],"Behavioral: Child Anxiety Learning Modules--Relaxation (CALM-R)",{"label":21,"type":22,"description":23,"interventionNames":24},"Waitlist control","NO_INTERVENTION","Within each nurse, 20% (1 in 5) children will be randomly assigned to wait a period of eight weeks prior to starting the intervention with their school nurse. During this period, the child is not prevented from seeing the school nurse, nor are they prevented from continuing to utilize stable doses of community treatment (i.e., therapy outside of school or medication); nurses are simply asked to provide normal support and avoid using techniques specific to CALM or CALM-R. After the 8 weeks, youth are re-evaluated and nurses begin delivering the intervention to the student.",null,[26,30],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":24},"BEHAVIORAL","CALM is a cognitive-behavioral intervention for childhood anxiety. CALM consists of five modules. The primary components include psychoeducation, relaxation training (C), behavioral exposure (A), cognitive restructuring (L), and relapse prevention (M). There is also an optional parent psychoeducation module. Students randomized to the CALM condition will receive the 5 modules over 8 weeks.",[9],{"type":27,"name":15,"description":31,"armGroupLabels":32,"otherNames":24},"CALM-R serves as an active comparison condition to CALM and consists of 5 modules of relaxation skills. The key components of CALM-R include psychoeducation, deep breathing, progressive muscle relaxation, guided imagery, and relapse prevention. Students randomized to the CALM-R condition will receive the 5 modules over 8 weeks.",[15],[34,37],{"name":35,"affiliation":5,"role":36},"Golda S Ginsburg, Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":39,"role":36},"Kelly Drake, Ph.D.","Johns Hopkins University",[41,45],{"name":35,"role":42,"phone":43,"phoneExt":24,"email":44},"CONTACT","8605233788","gginsburg@uchc.edu",{"name":38,"role":42,"phone":46,"phoneExt":24,"email":47},"4108007591","kdrake2@jhmi.edu",[49,71],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University of Connecticut School of Medicine","RECRUITING","West Hartford","Connecticut","06119","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-72.74204,41.76204,{"lat":61,"lon":60},[64,67,69],{"name":65,"role":42,"phone":66,"phoneExt":24,"email":44},"Golda Ginsburg, Ph.D.","860-523-3788",{"name":24,"role":42,"phone":24,"phoneExt":24,"email":68},"issmith@uchc.edu",{"name":70,"role":42,"phone":24,"phoneExt":24,"email":24},"Golda Ginsburg",{"facility":72,"status":51,"city":73,"state":74,"zip":75,"country":55,"countryCode":56,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Anxiety Treatment Center of Maryland","Columbia","Maryland","21045",{"type":58,"coordinates":77},[78,79],-76.83942,39.24038,{"lat":79,"lon":78},[82,83,85],{"name":38,"role":42,"phone":46,"phoneExt":24,"email":47},{"name":24,"role":42,"phone":84,"phoneExt":24,"email":24},"6786176562",{"name":38,"role":42,"phone":24,"phoneExt":24,"email":24},{"type":36,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Golda S. Ginsburg","Professor","100415762","efficacy-trial-of-the-calm-intervention-100415762",false,"NCT04693858","Efficacy Trial of the CALM Intervention","Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: an Efficacy Trial of the CALM Intervention","Student Inclusion Criteria:\n\n* Be between the ages of 5-12\n* Have elevated anxiety symptoms as indicated by a) a total SCARED score of 15 or higher based on parent and\u002For child report using the full SCARED from the baseline evaluation, and\u002For b) a Clinician Severity Rating of 3 or higher on any anxiety diagnosis from the Anxiety Disorders Interview Schedule for Children DSM-V (ADIS)\n* Be fluent in English in order to provide informed consent and assent for their participation and to complete the study measures.\n* Children on a stable dose of pharmacological\u002Fpsychotherapeutic treatment will be eligible as long as the dose has been stable for at least 4 weeks and no changes are considered for the duration of the intervention phase of the study (8 weeks)\n\nStudent Exclusion Criteria:\n\n* Children who do not meet the inclusion criteria\n\nNurse Inclusion Criteria:\n\n* Nurses must be a Registered Nurse (RN) or another similar medical professional\n* Nurses must be work in the role of a school nurse\n* Nurses must be fluent in English","ALL","5 Years","12 Years",{"count":100,"type":101},218,"ESTIMATED","INTERVENTIONAL",[104],"NA","Excessive anxiety among elementary students is highly prevalent and associated with impairment in academic, social, and behavioral functioning. The primary aim of this project is to evaluate the initial efficacy of a brief nurse-delivered intervention (CALM: Child Anxiety Learning Modules), relative to a credible comparison (CALM-R, relaxation skills only) and a waitlist control for reducing anxiety symptoms and improving education outcomes at post intervention and at a 1-year follow-up. In addition, the research team will assess the cost effectiveness of CALM versus CALM-R and the waitlist control and examine potential predictors, moderators, and mediators of CALM's impact on child outcomes based on the proposed theory of change.",[107],"Anxiety Disorder of Childhood",[109,110,111,112,113,114],"Anxiety","Child anxiety","School-based interventions","School nursing","Brief anxiety interventions","Cognitive-behavioral therapy","2024-12-04",{"date":117,"type":118},"2024-12-09","ACTUAL",{"date":120,"type":118},"2020-12-01",{"date":122,"type":101},"2026-07-30",{"name":5,"class":6},2]