[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630996":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":44,"locations":50,"responsibleParty":118,"collaborators":122,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":142,"sex":143,"minAge":144,"maxAge":11,"enrollmentInfo":145,"targetDuration":11,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":155,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"University Hospital Heidelberg","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group 1-Lighthouse Program","EXPERIMENTAL",null,[13],"Other: Lighthouse Program",{"label":15,"type":10,"description":11,"interventionNames":16},"Intervention Group 2-Mentalization Based Skills Training for Parents",[17],"Other: Mentalization Based Skills Training",{"label":19,"type":20,"description":11,"interventionNames":21},"Active control group","ACTIVE_COMPARATOR",[22],"Other: Lighthouse program parenting guidebook",[24,31,38],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Lighthouse Program","The Reflective Parenting Lighthouse Program (Byrne et al., 2019; Taubner et al., 2025) consists of 10 weekly group sessions targeting secure attachment parenting behaviors, reflective parenting and dysfunctional parental behavior related to parental mental health problems or trauma.",[9],[29,30],"Lighthouse parenting program","Long program",{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Mentalization Based Skills Training","The Mentalization Based Skills Training (MBST-P) consists of 6 bi-weekly group sessions and trains essential parental skills on attentional control, emotion regulation and reflective functioning using role plays with the imagined child. The training is based on the EFST-P training (Dolhanty et al., 2022) and adapted by adding a mentalization component for the purpose of the FLOW-study.",[15],[36,37],"(MBST-P)","short program",{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Lighthouse program parenting guidebook","Parenting guidebook on the lighthouse-parent training program (Taubner \\& Byrne 2026; The Little Boat and its Lighthouse)",[19],[43],"Parenting guide",[45],{"name":46,"role":47,"phone":48,"phoneExt":11,"email":49},"Svenja Taubner, Prof.Dr.","CONTACT","+49(0)6221564700","svenja.taubner@med.uni-heidelberg.de",[51,71,87,102],{"facility":52,"status":53,"city":54,"state":11,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Institut für Psychosoziale Prävention-Department für Psychosoziale Medizin, Prävention und Familiengesundheit-Universitätsklinikum Heidelberg","RECRUITING","Heidelberg","69115","Germany","DE",{"type":59,"coordinates":60},"Point",[61,62],8.69079,49.40768,{"lat":62,"lon":61},[65,67],{"name":46,"role":47,"phone":66,"phoneExt":11,"email":49},"+49(0)6221-564700",{"name":68,"role":47,"phone":69,"phoneExt":11,"email":70},"Sophia Peter, Msc.","+49 6221 56 37569","sophia.peter@med.uni-heidelberg.de",{"facility":72,"status":53,"city":73,"state":11,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Developmental Psychopathology Research Center-Institute of Psychology- Faculty of Philosophy-Vilnius university","Vilnius","01513","Lithuania","LT",{"type":59,"coordinates":78},[79,80],25.2798,54.68916,{"lat":80,"lon":79},[83],{"name":84,"role":47,"phone":85,"phoneExt":11,"email":86},"Rasa Barkauskienė, Prof.Dr.","+370 5 266 7605","rasa.barkauskiene@fsf.vu.lt",{"facility":88,"status":53,"city":89,"state":11,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Department of Education Sciences-Universidad de La Rioja","Logroño","26004","Spain","ES",{"type":59,"coordinates":94},[95,96],-2.45115,42.46615,{"lat":96,"lon":95},[99],{"name":100,"role":47,"phone":11,"phoneExt":11,"email":101},"Eduardo Fonseca Pedrero, Prof.Dr.","eduardo.fonseca@unirioja.es",{"facility":103,"status":53,"city":104,"state":11,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Faculty of Psychology and Educational Sciences-University of Geneva","Geneva","1205","Switzerland","CH",{"type":59,"coordinates":109},[110,111],6.14569,46.20222,{"lat":111,"lon":110},[114],{"name":115,"role":47,"phone":116,"phoneExt":11,"email":117},"Martin Debbané, Prof.Dr.","+22 3799418","Martin.Debbane@unige.ch",{"type":119,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Svenja Taubner","Prof.Dr.",[123,125,127,129,132],{"name":124,"class":6},"University of Geneva, Switzerland",{"name":126,"class":6},"University of La Rioja",{"name":128,"class":6},"Vilnius University",{"name":130,"class":131},"CHANSE (Collaboration of Humanities and Social Sciences in Europe)","UNKNOWN",{"name":133,"class":6},"Heidelberg University","100630996","a-mentalization-based-prevention-program-to-foster-well-being-and-mental-health-in-pre-adolescent-children-and-their-families-100630996",false,"NCT07494929","A Mentalization Based Prevention Program to Foster Well-Being and Mental Health in Pre-Adolescent Children and Their Families","Foster Long-term Well-being in Pre-adolescent Children and Their Families","FLOW","Inclusion Criteria:\n\n* Children: Age range 8 to 11 year olds\n* All participants: Sufficient language knowledge (self-reported)\n\nExclusion Criteria:\n\n* Children: Missing consent forms from all guardians\n* Datasets that indicate random answer patterns or non-engaged responding",true,"ALL","8 Years",{"count":146,"type":147},15200,"ESTIMATED","INTERVENTIONAL",[150],"NA","The FLOW project involves the implementation and rigorous evaluation of an evidence-based, multi-level mentalization prevention program targeting social and psychological determinants of well-being in four European countries (Germany, Lithuania, Spain, and Switzerland). Prevention programs will be tailored to the needs of 8-10 year old children in elementary schools and their parents. All children will participate in a project day focused on mental health. Parents will either attend one of two parent trainings of varying lengths or receive a parenting guidebook. A total of 5,000 children, along with their teachers and parents, are included in the survey. To measure long-term effects, surveys are conducted over the course of a whole year.\n\nThe project examines the following hypotheses:\n\nPrimary hypotheses:\n\nA multilevel mentalization based prevention program will lead to significantly greater improvements in well-being and mental health among children and parents compared to control groups, as measured at the post-intervention assessment.\n\nSecondary hypotheses:\n\n1. A universal prevention program on mental health enhances help-seeking behavior and reduces mental health stigma among children, parents and teachers at post and follow-up measurement.\n2. A universal prevention program on mental health improves classroom climate and increases teaching efficacy at post and follow-up measurement.\n3. A multi-level mentalization based prevention program leads to greater improvements in well-being and mental health among children and parents than control groups, as measured at follow-up.\n4. A multi-level mentalization based prevention program leads to greater improvements in parental efficacy and family adjustment in parents and reduces parental stress compared to control groups at post and follow-up measurement.\n5. The longer intervention group will yield greater improvements in outcome measures compared to the shorter intervention group.",[153,154],"Mental Health","Well-being",[156,157,158,159,160,153,161],"Randomized Control Trial","Parent trainings","Mentalization","Well-Being","Primary school","Prevention","2026-07-28",{"date":164,"type":165},"2026-07-30","ACTUAL",{"date":167,"type":165},"2026-04-14",{"date":169,"type":147},"2028-03",{"name":120,"class":6},4]