A Strong Start in Life - ELAS 2.0: A Digital Learning Program to Promote a Healthy Pregnancy and Early Child Protection (ELAS 2)
2026년 8월 21일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
54
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Annette Binder, Dr. med.
- 전화번호: +49-7071 29-86542
- 이메일: a.binder@med.uni-tuebingen.de
연구 장소
-
-
Baden-Wurttemberg
-
Tübingen, Baden-Wurttemberg, 독일, 72076
- University Hospital Tübingen
-
연락하다:
- Annette Binder, Dr. med.
- 전화번호: +49-7071-29-86542
- 이메일: a.binder@med.uni-tuebingen.de
-
수석 연구원:
- Annette Binder, Dr. med.
-
부수사관:
- Anne Herschbach
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
empathy in conversation with pregnant women who may drink alcohol
기간: 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
기간: 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
기간: 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).
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
sense of responsibility
기간: 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
기간: 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
기간: 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.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Annette Binder, Dr. med., University Hospital Tuebingen
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 24일
기본 완료 (추정된)
2027년 6월 30일
연구 완료 (추정된)
2027년 6월 30일
연구 등록 날짜
최초 제출
2026년 8월 18일
QC 기준을 충족하는 최초 제출
2026년 8월 21일
처음 게시됨 (실제)
2026년 8월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 21일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2026-0441-BO
- SM22-6940-17/8 (기타 보조금/기금 번호: Ministry of Social Affairs, Labour and Health of Baden-Württemberg)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
After publication of the results of the primary outcome
IPD 공유 액세스 기준
open access
IPD 공유 지원 정보 유형
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .