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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. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

54

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tyskland
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Tyskland, 72076
        • University Hospital Tübingen
        • Ta kontakt med:
        • Hovedetterforsker:
          • Annette Binder, Dr. med.
        • Underetterforsker:
          • Anne Herschbach

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
empathy in conversation with pregnant women who may drink alcohol
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
sense of responsibility
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital Tuebingen

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

  • 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.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

24. august 2026

Primær fullføring (Antatt)

30. juni 2027

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

18. august 2026

Først innsendt som oppfylte QC-kriteriene

21. august 2026

Først lagt ut (Faktiske)

24. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-0441-BO
  • SM22-6940-17/8 (Annet stipend/finansieringsnummer: Ministry of Social Affairs, Labour and Health of Baden-Württemberg)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

After publication of the results of the primary outcome

Tilgangskriterier for IPD-deling

open access

IPD-deling Støtteinformasjonstype

  • SEVJE
  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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