[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636602":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":19,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":73,"whyStopped":19,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Brave Elephant Program","EXPERIMENTAL","The Brave Elephant Program is a multicomponent intervention delivered over 18 weeks targeting early childhood education professionals, preschool children and their parents.",[13],"Behavioral: Brave Elephant Program",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BEHAVIORAL","The Brave Elephant Program is implemented across three parallel components. The professional component is delivered by two trained psychologists through psychoeducational workshops and individualized classroom coaching sessions. This component focuses on understanding behavioral inhibition, promoting positive relationships, emotional regulation, social engagement and social problem-solving. The child component is delivered by early education professionals in the classroom through age-appropriate didactic activities (e.g., modeling\u002Frole-play, mindfulness activities, and supervised free play with adults and peers to enhance socioemotional competence. The family component is also delivered by early education professionals, by sharing the materials and activities that are implemented in the classroom with parents to promote skill generalization across contexts.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Maryse Guedes","CONTACT","+351 218 811 700","mguedes@ispa.pt",[27],{"facility":28,"status":19,"city":29,"state":19,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Ispa - Instituto Universitário","Lisbon","1149-041","Portugal","PT",{"type":34,"coordinates":35},"Point",[36,37],-9.1498,38.72509,{"lat":37,"lon":36},[40,41],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"name":22,"role":42,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"type":44,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100636602","feasibility-and-preliminary-outcomes-of-the-brave-elephant-program-a-single-arm-pretest-posttest-study-100636602",false,"NCT07567820","Feasibility and Preliminary Outcomes of the Brave Elephant Program: A Single-Arm Pretest-Posttest Study","Feasibility and Preliminary Outcomes of the Brave Elephant Program: A Single-Arm Pretest-Posttest Study in Early Childhood Education Settings","Brave_Elephant","Inclusion criteria:\n\n* Children's age between 3 and 6 years\n* Parents' written informed consent for children's participation in the study.\n* Children's informed assent to participate in the study.\n* Parents' ability to read and understand Portuguese.\n* Early childhood and care professionals' ability to read and understand Portuguese\n* Early childhood and care professionals' full-time contract for the school year.\n\nExclusion criteria:\n\n* Children's developmental disorders\n* Children's, parents' and early education professionals' are enrolled in another psychological intervention.",true,"ALL","3 Years","6 Years",{"count":58,"type":59},60,"ESTIMATED","INTERVENTIONAL",[62],"NA","Anxiety disorders are highly prevalent in childhood and have increased following the COVID-19 pandemic. Behavioral inhibition in early childhood is a well-established risk factor for later anxiety. School-based preventive interventions that target both classroom environments and individual child characteristics may help reduce early risk and improve socioemotional development. Interventions delivered in preschool settings that address the needs of behaviorally inhibited children, while also supporting professional development, may improve the quality of interactions within the classroom and with families, and promote positive developmental outcomes.\n\nThe Brave Elephant Program is an evidence-based intervention grounded in a bioecological developmental framework. It aims to empower early childhood education professionals to promote socioemotional competence and resilience in all children, while addressing the specific needs of behaviorally inhibited preschoolers and enhancing educators' professional development. This study will evaluate the feasibility, acceptability, and preliminary outcomes of the program using a single-arm pretest-posttest design.",[65],"Anxiety",[67,68,69,70,71,72],"Behavioral inhibition","Preschool age","Teacher-child relationship","Peer play","Teacher-parent relationship","Teacher mental health","NOT_YET_RECRUITING","2026-05-05",{"date":76,"type":77},"2026-05-08","ACTUAL",{"date":79,"type":59},"2026-09",{"date":81,"type":59},"2027-09",{"name":5,"class":6},1]