[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653054":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":31,"studyPopulation":31,"armGroups":39,"interventions":46,"overallOfficials":52,"centralContacts":57,"locations":62,"responsibleParty":82,"collaborators":31,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":31,"enrollmentInfo":94,"targetDuration":31,"studyType":97,"phases":98,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":106,"whyStopped":31,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University Hospital Tuebingen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":31},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"empathy in conversation with pregnant women who may drink alcohol","Empathy with regard to working with pregnant women who may drink alcohol is being assessed with the Jefferson Scale of Empathy - Health Professionals version (JSE-HP), translated into German. The questionnaire includes 20 items, which have to be answered on a 7-point Likert scale. After reverse coding of negatively worded items, item scores are summed to a total score ranging from 20 to 140, with higher scores indicating greater empathy.","At enrollment (T0), immediately after completion of the e-learning intervention, up to 8 weeks after baseline (T1), 3 weeks after completion of the e-learning intervention (T2), and 12 weeks after completion of the e-learning intervention (T3).",{"measure":14,"description":15,"timeFrame":12},"self-efficacy with regard to working with pregnant women who may drink alcohol","Self-efficacy with regard to working with pregnant women who may drink alcohol is being assessed with the German version of the General Self-Efficacy Scale (GSE). It includes 10 items which have to be answered on a 4-point Likert scale. Item scores are summed to a total score ranging from 10 to 40, with higher scores indicating greater general self-efficacy.",{"measure":17,"description":18,"timeFrame":12},"sense of competence with regard to working with pregnant women who may drink alcohol","Sense of competence with regard to working with pregnant women who may drink alcohol is assessed with the Basic Need Satisfaction at Work Scale - Competence subscale (German version). The subscale includes six items rated on a 7-point Likert scale. After reverse coding of negatively worded items, item scores can be summed to a total score ranging from 6 to 42 or averaged to obtain a mean score ranging from 1 to 7. Higher scores indicate greater perceived competence.",[20,23,27],{"measure":21,"description":22,"timeFrame":12},"sense of responsibility","This variable should assess whether individuals feel that it is their task to ask pregnant women about their alcohol consumption and to educate about alcohol usage in pregnancy. In addition, participants will be asked which professional group they consider responsible. The four items were designed by the researchers:\n\nWhich profession is mainly responsible for asking about alcohol consumption in pregnancy? \\[list of professions\\] Which profession is mainly responsible for educating about alcohol consumption in pregnancy? \\[list of professions\\] How much do you feel responsible for asking about alcohol consumption in pregnancy? \\[visual analogue scale, 0-100\\] How much do you feel responsible for asking\u002Feducating about alcohol consumption in pregnancy? \\[visual analogue scale, 0-100\\] 0 indicates no perceived responsibility and 100 indicates full perceived responsibility. Higher scores indicate a greater sense of responsibility.",{"measure":24,"description":25,"timeFrame":26},"feedback on the e-learning","Open-ended questions about participants' opinions about the e-learning intervention (T1 via questionnaire).","immediately after completion of the e-learning intervention, up to 8 weeks after baseline (T1)",{"measure":28,"description":29,"timeFrame":30},"Perceived responsibility regarding addressing alcohol use during pregnancy - qualitative assessment","Perceived responsibility for asking pregnant women about alcohol consumption and providing information about alcohol-related risks during pregnancy will be explored in optional semi-structured interviews.","From completion of the e-learning intervention (up to 8 weeks after enrollment) to 12 weeks after completion of the e-learning intervention.",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":35,"primaryPurpose":36,"observationalModel":31,"timePerspective":31,"maskingInfo":37},"NA","SINGLE_GROUP","This study is a one-group pre-post design. All participants receive the intervention (= get access to the E-Learning) and are being asked to complete the questionnaires at four measurement points: T0: prior to the e-learning, T1: after completing the e-learning, T2: three weeks later, and T3: nine more weeks later (12 weeks after completion).","HEALTH_SERVICES_RESEARCH",{"masking":38,"maskingDescription":31,"whoMasked":31},"NONE",[40],{"label":41,"type":42,"description":43,"interventionNames":44},"Intervention group e-learning on alcohol use in pregnancy","EXPERIMENTAL","All participants will receive access to an asynchronous interprofessional e-learning program on addressing alcohol use during pregnancy. The program comprises three modules covering (1) background knowledge on alcohol use in pregnancy, fetal alcohol spectrum disorders, stigma, and reasons for continued alcohol use during pregnancy; (2) communication skills training based on motivational interviewing principles; and (3) interactive case-based learning activities. Participants have eight weeks to complete the approximately nine-hour program.",[45],"Behavioral: Interprofessional E-Learning Program on Alcohol Use During Pregnancy",[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":31},"BEHAVIORAL","Interprofessional E-Learning Program on Alcohol Use During Pregnancy","An asynchronous interprofessional e-learning program designed to improve knowledge, communication skills, and reflective practice regarding alcohol use during pregnancy and stigma. The program comprises three modules: (1) background knowledge on alcohol use in pregnancy, fetal alcohol spectrum disorders, stigma, and reasons for continued alcohol use; (2) communication skills training based on motivational interviewing principles; and (3) interactive case-based learning. Educational strategies include expert videos, quizzes, reflective exercises addressing personal attitudes and potential stigmatizing beliefs, and twelve interactive patient scenarios. The estimated completion time is approximately nine hours.",[41],[53],{"name":54,"affiliation":55,"role":56},"Annette Binder, Dr. med.","University Hospital Tübingen","PRINCIPAL_INVESTIGATOR",[58],{"name":54,"role":59,"phone":60,"phoneExt":31,"email":61},"CONTACT","+49-7071 29-86542","a.binder@med.uni-tuebingen.de",[63],{"facility":55,"status":31,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Tübingen","Baden-Wurttemberg","72076","Germany","DE",{"type":70,"coordinates":71},"Point",[72,73],9.05222,48.52266,{"lat":73,"lon":72},[76,78,79],{"name":54,"role":59,"phone":77,"phoneExt":31,"email":61},"+49-7071-29-86542",{"name":54,"role":56,"phone":31,"phoneExt":31,"email":31},{"name":80,"role":81,"phone":31,"phoneExt":31,"email":31},"Anne Herschbach","SUB_INVESTIGATOR",{"type":83,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100653054","a-strong-start-in-life---elas-20-a-digital-learning-program-to-promote-a-healthy-pregnancy-and-early-child-protection-100653054",false,"NCT07782190","A Strong Start in Life - ELAS 2.0: A Digital Learning Program to Promote a Healthy Pregnancy and Early Child Protection","ELAS 2","Inclusion Criteria:\n\n* Being a physician, midwife, nurse, social worker, pharmacist or other health professional working in maternity care, psychiatry or child protection services\n* 18 years of age or older\n* Sufficient German language skills\n* Internet access\n\nExclusion Criteria:\n\n* Not working in the before-named fields\n* Younger than 18 years of age\n* Insufficient German language skills\n* No internet access",true,"ALL","18 Years",{"count":95,"type":96},54,"ESTIMATED","INTERVENTIONAL",[33],"The goal of this clinical trial is to evaluate an adapted version of a previously developed e-learning tool to teach sensitive conversations to health professionals working in maternity care. The goal of the e-learning intervention is to increase health professionals' empathy, self-efficacy, and sense of competence regarding their conversations with pregnant women who may drink alcohol.\n\nThe main question it aims to answer is:\n\nCan participation in the e-learning intervention lead to higher values in empathy, self-efficacy, and sense of competence in health professionals working with pregnant women who may drink alcohol during pregnancy (quantitative evaluation)?\n\nDoes the participation additionally lead to a higher sense of responsibility (being responsible to ask about alcohol consumption and explain possible risks thereof)? The second research question (secondary outcome) should be evaluated quantitatively and qualitatively.\n\nWhat feedback do participants of the e-learning have about it (qualitative evaluation)?\n\nParticipants will\n\nComplete four web-based questionnaires (one before and three after participation in the e-learning)\n\n* Participate in the e-learning intervention (= get access to the webpage for eight weeks). The intervention includes an approximately 9-hour asynchronous e-learning program, covering background knowledge on alcohol use during pregnancy and communication skills, including motivational interviewing, with interactive case-based exercises and two assessments.\n* Some (not all) participants will participate in individual phone interviews exploring perceived professional responsibility regarding alcohol use during pregnancy and feedback on the e-learning intervention.",[101],"Alcohol Use During Pregnancy",[101,103,104,105],"e-learning","pregnancy","medical education","NOT_YET_RECRUITING","2026-08-21",{"date":109,"type":110},"2026-08-24","ACTUAL",{"date":109,"type":96},{"date":113,"type":96},"2027-06-30",{"name":5,"class":6},1]