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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 (ELAS 2)

21 augustus 2026 bijgewerkt door: University Hospital Tuebingen

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

54

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Duitsland
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Duitsland, 72076
        • University Hospital Tübingen
        • Contact:
        • Hoofdonderzoeker:
          • Annette Binder, Dr. med.
        • Onderonderzoeker:
          • Anne Herschbach

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention group e-learning on alcohol use in pregnancy
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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
empathy in conversation with pregnant women who may drink alcohol
Tijdsspanne: 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).
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
Tijdsspanne: 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 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
Tijdsspanne: 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 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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
sense of responsibility
Tijdsspanne: 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).

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital Tuebingen

Onderzoekers

  • Hoofdonderzoeker: Annette Binder, Dr. med., University Hospital Tuebingen

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

24 augustus 2026

Primaire voltooiing (Geschat)

30 juni 2027

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

18 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 augustus 2026

Eerst geplaatst (Werkelijk)

24 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

21 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-0441-BO
  • SM22-6940-17/8 (Ander subsidie-/financieringsnummer: Ministry of Social Affairs, Labour and Health of Baden-Württemberg)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

An anonymized individual participant dataset (IPD) underlying the main study results will be made publicly available via Figshare following publication of the primary outcome results.

IPD-tijdsbestek voor delen

After publication of the results of the primary outcome

IPD-toegangscriteria voor delen

open access

IPD delen Ondersteunend informatietype

  • SAP
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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