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

NCT07782190 | Not Yet Recruiting

• 2 other identifiers: 2026-0441-BOSM22-6940-17/8
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use During Pregnancy

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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).

• 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.

  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).

• 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.

  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).

Secondary Outcomes (3)

• sense of responsibility

  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).

• feedback on the e-learning

  immediately after completion of the e-learning intervention, up to 8 weeks after baseline (T1)

• Perceived responsibility regarding addressing alcohol use during pregnancy - qualitative assessment

  From completion of the e-learning intervention (up to 8 weeks after enrollment) to 12 weeks after completion of the e-learning intervention.

Study Arms (1)

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.

Behavioral: Interprofessional E-Learning Program on Alcohol Use During Pregnancy

Interventions

Interprofessional E-Learning Program on Alcohol Use During Pregnancy BEHAVIORAL

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.

Intervention group e-learning on alcohol use in pregnancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (6)

• Deci, E. L., & Ryan, R. M. (2000). The "what" and "why" of goal pursuits: Human needs and the self-determination of behavior. Psychological inquiry, 11(4), 227-268.

  BACKGROUND

• Deci, E. L., Ryan, R. M., Gagné, M., Leone, D. R., Usunov, J., & Kornazheva, B. P. (2001). Need satisfaction, motivation, and well-being in the work organizations of a former eastern bloc country: A cross-cultural study of self-determination. Personality and social psychology bulletin, 27(8), 930-942.)

  BACKGROUND

• Schwarzer, R., & Jerusalem, M. (Eds.). (1999). Skalen zur Erfassung von Lehrer- und Schülermerkmalen: Dokumentation der psychometrischen Verfahren im Rahmen der Wissenschaftlichen Begleitung des Modellversuchs Selbstwirksame Schulen. Berlin: Freie Universität Berlin.

  BACKGROUND

• Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37). Windsor, England: NFER-NELSON.

  BACKGROUND

• Hojat, M (2016) Empathy in health professions education and patient care. New York; Springer International.

  BACKGROUND

• Hojat M, Gonnella JS, Nasca TJ, Mangione S, Vergare M, Magee M. Physician empathy: definition, components, measurement, and relationship to gender and specialty. Am J Psychiatry. 2002 Sep;159(9):1563-9. doi: 10.1176/appi.ajp.159.9.1563.

  PMID: 12202278 BACKGROUND

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Annette Binder, Dr. med.

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annette Binder, Dr. med.

CONTACT

+49-7071 29-86542; a.binder@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 24, 2026
• Study Start: August 24, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: After publication of the results of the primary outcome
• Access Criteria: open access

Locations

DE (1)