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A Strong Start in Life - ELAS 2.0: A Digital Learning Program to Promote a Healthy Pregnancy and Early Child Protection

A Strong Start in Life - ELAS 2.0: A Digital Learning Program to Promote a Healthy Pregnancy and Early Child Protection

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07782190
Acronym
ELAS 2
Enrollment
54
Registered
2026-08-24
Start date
2026-08-24
Completion date
2027-06-30
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use During Pregnancy

Keywords

Alcohol Use During Pregnancy, e-learning, pregnancy, medical education

Brief summary

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. The main question it aims to answer is: Can 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)? Does 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. What feedback do participants of the e-learning have about it (qualitative evaluation)? Participants will Complete four web-based questionnaires (one before and three after participation in the e-learning) * 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. * 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.

Interventions

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.

Sponsors

University Hospital Tuebingen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Being a physician, midwife, nurse, social worker, pharmacist or other health professional working in maternity care, psychiatry or child protection services * 18 years of age or older * Sufficient German language skills * Internet access

Exclusion criteria

* Not working in the before-named fields * Younger than 18 years of age * Insufficient German language skills * No internet access

Design outcomes

Primary

MeasureTime frameDescription
empathy in conversation with pregnant women who may drink alcoholAt 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).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.
self-efficacy with regard to working with pregnant women who may drink alcoholAt 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).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.
sense of competence with regard to working with pregnant women who may drink alcoholAt 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).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.

Secondary

MeasureTime frameDescription
sense of responsibilityAt 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).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: Which 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/educating 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.
feedback on the e-learningimmediately after completion of the e-learning intervention, up to 8 weeks after baseline (T1)Open-ended questions about participants' opinions about the e-learning intervention (T1 via questionnaire).
Perceived responsibility regarding addressing alcohol use during pregnancy - qualitative assessmentFrom completion of the e-learning intervention (up to 8 weeks after enrollment) to 12 weeks after completion of the e-learning intervention.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.

Countries

Germany

Contacts

CONTACTAnnette Binder, Dr. med.
a.binder@med.uni-tuebingen.de+49-7071 29-86542
PRINCIPAL_INVESTIGATORAnnette Binder, Dr. med.

University Hospital Tübingen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026