[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546088":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":19,"centralContacts":32,"locations":40,"responsibleParty":57,"collaborators":19,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":19,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":86,"whyStopped":19,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"RWTH Aachen University","OTHER",[8,15],{"label":9,"type":6,"description":10,"interventionNames":11},"Intervention group","blinded-care counselling + App STEPS + digital and mental literacy training",[12,13,14],"Other: blinded-care counselling","Other: App STEPS","Other: digital and mental literacy training",{"label":16,"type":17,"description":18,"interventionNames":19},"TAU group (Treatment as Usual)","NO_INTERVENTION","digital and mental literacy training",null,[21,25,29],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":19},"blinded-care counselling","The intervention is a implementation of a weekly psychological counseling for psychiatric problems via videoconference combined with an additionally digital support using a well-established mobile treatment system STEPS®. The intervention will include: 2) weekly counselling over 6 weeks via videoconference for adolescents and their parents.\n\nThe counselling will be provided by experienced psychologists as employers of the Clinic of Child and Adolescent Psychiatry, RWTH Aachen University, the counselling will be supervised by the leading psychologist of the clinic. The counselling will include psychoeducative elements about psychological and psychosocial problems, behavioral interventions from cognitive-behavioral therapy, psychological techniques for better coping with stress, different therapeutic tasks such as fear exposure, activation exercises e.c. The students will be instructed to use the mobile treatment system STEPS in order to continue therapy at home.",[9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":19},"App STEPS","The intervention is a implementation of a weekly psychological counseling for psychiatric problems via videoconference combined with an additionally digital support using a well-established mobile treatment system STEPS®. The intervention will include: 3) blinded-care use of the mobile treatment system STEPS®.\n\nThis is transdiagnostic digital treatment system which consists of a students front-end as an App and a therapist front-end as an online platform. The App and the platform are connected to each other. In such a way, an effective data transter (for example, symptom evaluation by the student and tasks and requests by the therapist), direct communication between a student and a therapist, as well as registration of emergency situation, are possible.",[9],{"type":6,"name":18,"description":30,"armGroupLabels":31,"otherNames":19},"The intervention is a implementation of a weekly psychological counseling for psychiatric problems via videoconference combined with an additionally digital support using a well-established mobile treatment system STEPS®.\n\nThe intervention will include: 1) digital and mental literacy training for children, parents and teachers in the school.\n\nThis training program (4 weeks, 8 session a 2 lesson units, 2 sessions a week) includes information about rules and functions by using mobile applications, safety aspects of personal data, risks associated with data sharing, sexing and cybergrooming, managing social media, handling with fake news, influence of social media on mental health, forms of digital violence and strategies to cope with them.",[9],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":19,"email":37},"Michael Siniatchkin, Prof. Dr.","CONTACT","+49 241 80-89362","msiniatchkin@akaachen.de",{"name":39,"role":35,"phone":19,"phoneExt":19,"email":19},"Anna Sotnikova, Dr.",[41],{"facility":42,"status":19,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Clinic of Child and Adolescent Psychiatry, RWTH Aachen University","Aachen","North Rhine-Westphalia","52074","Germany","DE",{"type":49,"coordinates":50},"Point",[51,52],6.08342,50.77664,{"lat":52,"lon":51},[55,56],{"name":34,"role":35,"phone":19,"phoneExt":19,"email":19},{"name":39,"role":35,"phone":19,"phoneExt":19,"email":19},{"type":58,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100546088","prevention-programme-for-improvement-of-well-being-and-level-of-participation-in-adolescents-with-enhanced-psychiatric-burden-in-the-school-environment-100546088",false,"NCT06390384","Prevention Programme for Improvement of Well-being and Level of Participation in Adolescents With Enhanced Psychiatric Burden in the School Environment.","STEPS@SCHOOL","Inclusion Criteria:\n\n* Children and adolescents of both genders (w : m = 1 : 1) aged from 10 to 14 years\n* Psychiatric symptoms characterized using SDQ-25 with the cutoff \\> 17\n* Regular school attendence\n\nExclusion Criteria:\n\n* IQ \\\u003C80, ongoing psychiatric or psychotherapeutic treatment with regular appointments (at least once a month).","ALL","10 Years","14 Years",{"count":70,"type":71},100,"ESTIMATED","INTERVENTIONAL",[74],"NA","The objectives of this two-arm phase-IIa randomized, controlled study are:\n\n* to prove whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support (blinded care approach) and a training of digital and mental health literacy is superior to a teacher-guided training of digital and mental health literacy only (treatment as usual) concerning the reduction of psychiatric burden in adolescents.\n* to improve the well-being and level of participation in adolescents at risk for psychiatric disorders.\n* to reduce the expression of psychiatric symptoms in adolescents with enhanced psychiatric burden.\n* to test whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support is well accepted by students, their parents, and teachers.\n* to identify individual factors predicting the improvement of well-being and level of participation in adolescents as well as the acceptance of the prevention program in all subjects involved (students, parents, teachers, psychologists).\n* to investigate whether the clinic-guided personal counseling with a therapy-assistive digital support causes reduction of primary and secondary costs in the psychosocial support system and represents an economic advantage.",[77,78,26],"Blended-care Counselling","Digital and Mental Literacy Training",[80,81,82,83,84,85],"eMental health","digital health","blended care treatment","students at risk in schools","psychiatric disorders","adolescents","NOT_YET_RECRUITING","2024-04-25",{"date":89,"type":90},"2024-04-30","ACTUAL",{"date":92,"type":71},"2026-08-01",{"date":94,"type":71},"2028-12-31",{"name":5,"class":6},1]