[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545160":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":23,"locations":29,"responsibleParty":54,"collaborators":58,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":12,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":49,"whyStopped":12,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University Hospital, Geneva","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard informed consent","NO_INTERVENTION","According to ethical requirements of Swiss Human Research Act, the interviewer will explain the nature of the study, its purposes, duration, the potential risks and benefits it entails, and study procedures. He will inform that study participation is voluntary and that participants may withdraw at any time. He will also explain that the study is independent from the prison authorities. Participants will then be given time to read the informed consent, or, if they are not able to read, it will be read to them by the interviewer. The interviewer will answer all questions.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Modified teach-to-goal informed consent","EXPERIMENTAL","The standard process will first be used. After that, the interviewer will ask participants to summarize the content of the informed consent. The interviewer will correct not-well understood components and ask questions about forgotten components. In case of misconceptions, the participant will be asked to summarize again the corresponding components. A list of key components to be addressed will be developed by study team members, including experts in prison research and ethics, based on components listed in Art. 16 of the Swiss Human Research Act. The material of the informed consent of the parent-randomized controlled trial will be used.",[18],"Other: Modified teach-to-goal informed consent",[20],{"type":6,"name":14,"description":21,"armGroupLabels":22,"otherNames":12},"Enhanced procedure to improve informed consent in vulnerable populations.",[14],[24],{"name":25,"role":26,"phone":27,"phoneExt":12,"email":28},"Stéphanie Baggio, Prof.","CONTACT","+41216923238","stephanie.baggio@unil.ch",[30,48],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Geneva University Hospitals","NOT_YET_RECRUITING","Geneva","Canton of Geneva","1211","Switzerland","CH",{"type":39,"coordinates":40},"Point",[41,42],6.14569,46.20222,{"lat":42,"lon":41},[45],{"name":25,"role":26,"phone":46,"phoneExt":12,"email":47},"+41316846774","stephanie.baggio@unibe.ch",{"facility":31,"status":49,"city":33,"state":34,"zip":50,"country":36,"countryCode":37,"cosmosGeoPoint":51,"geoPoint":53,"contacts":12},"RECRUITING","1226",{"type":39,"coordinates":52},[41,42],{"lat":42,"lon":41},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Stéphanie Baggio","Prof. Dr. phil.",[59,61,63,66,67],{"name":60,"class":6},"University of Bern",{"name":62,"class":6},"Leiden University",{"name":64,"class":65},"School of Health Sciences Fribourg","UNKNOWN",{"name":5,"class":6},{"name":68,"class":6},"University of Lausanne","100545160","testing-a-new-method-to-improve-informed-consent-in-prison-research-100545160",false,"NCT06378281","Testing a New Method to Improve Informed Consent in Prison Research","Spark BATIR","Inclusion Criteria:\n\n* inclusion in the parent-RCT\n* age ≥ 18 years\n* good command of French\n* absence of acute psychiatric disorder\n* providing written informed consent for study participation in the parent-RCT\n\nExclusion Criteria:\n\n\\- none.","MALE","18 Years","65 Years",{"count":80,"type":81},100,"ESTIMATED","INTERVENTIONAL",[84],"NA","Understanding of informed consent is often limited in prison, due to unique challenges faced by detained people. This study will test a modified \"teach-to-goal\" informed consent process compared to standard procedures. Conducted within a larger study on psychiatric outcomes, it aims to enhance ethical practices for vulnerable populations.",[87],"ADHD",[89,90,91],"Informed consent","Prison","Ethics","2026-03-13",{"date":94,"type":95},"2026-03-17","ACTUAL",{"date":97,"type":95},"2024-05-01",{"date":99,"type":81},"2026-09-30",{"name":56,"class":6},2]