NCT07778251

Brief Summary

A major challenge in health care is equipping health professionals with skills to conduct sensitive conversations which is of importance in the treatment of patients suffering from stigmatized health behaviors such as addiction-related diseases. Alcohol use during pregnancy can cause adverse outcomes for the newborns. Therefore, sensitive conversations with pregnant women conducted by various health professionals who are in contact with them, is of importance. E-learning programs are a good option to teach health professionals with various background how to conduct sensitive conversations, using Motivational Interviewing. The goal of this clinical trial is to learn if the e-learning intervention can improve counseling about alcohol use in pregnancy in heathcare professionals like physicians, midwifes, social workers and others. The main questions it aims to answer is:

  • Can the e-learning intervention lead to more conversations about alcohol use in pregnancy ? This is being operationalized as follows: Do health professionals address womens' alcohol use more frequently after completion of the e-learning?
  • Does the e-learning additionally lead to higher values of the following variables (secondary outcomes): knowledge on alcohol use in pregnancy, communication skills, confidence, actual and desired conversation duration? To evaluate these research questions, the study contains two groups: an intervention group receiving the intervention (getting access to the e-learning for four weeks), and a waitlist-control-group which first has a waiting period and later receives the intervention as an incentive. The study has two main measurement point: at baseline (prior to the intervention respectively the waiting period), and after the intervention respectively the waiting period. The waitlist-control group has an additional measurement point after completion of the e-learning. The main hypothesis is that the intervention group shows a higher increase in the alcohol discussion proportion than the waitlist control group (using the measurement point before the e-learning). We therefore expect a significant group-time interaction in the planned repeated-measures ANOVAs for all variables. Participants were asked to complete online questionnaires before assignment to the intervention or waitlist control group and after completing the intervention or the waiting period, respectively. Participants in the intervention group were asked to complete an approximately 8-hour e-learning intervention within four weeks, covering background knowledge on alcohol use during pregnancy and communication skills, including motivational interviewing, with interactive case-based exercises and two assessments. Participants in the waitlist control group received access to the e-learning intervention after a two-month waiting period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2025

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2026

Completed
Last Updated

August 21, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

August 17, 2026

Last Update Submit

August 17, 2026

Conditions

Keywords

PregnancyAlcohol Use During PregnancyMedical Educatione-learning

Outcome Measures

Primary Outcomes (1)

  • alcohol discussion proportion

    Description: alcohol discussion proportion means the number of pregnant women the health professionals asked about their alcohol consumption in the previous week. To account for different amounts of women seen in a week, the proportion is calculated as a quotient as the number of pregnant women asked about their alcohol use divided by the total number of women seen in the previous week. Both numbers are self-reported by study participants as part of the web-based questionnaires.

    At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list

Secondary Outcomes (5)

  • knowledge on alcohol use in pregnancy

    At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list

  • communication skills

    At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list

  • confidence

    At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list

  • actual conversation duration

    At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list

  • desired conversation duration

    At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list

Study Arms (2)

intervention group receiving e-learning on alcohol use in pregnancy

EXPERIMENTAL

Participants in the intervention group received access to an asynchronous interprofessional e-learning program on addressing alcohol use during pregnancy. The program comprised 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 had four weeks to complete the approximately eight-hour program.

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

Waitlist Control Group (e-learning only as incentive after waiting time)

NO INTERVENTION

Participants in the waitlist control group did not receive the intervention during the waiting period (2 months). They completed the pre- and post-assessments before receiving access to the e-learning program. Following the post-assessment, participants received access to the e-learning program for four weeks and competed a post-assessment after the e-learning program.

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 eight hours.

intervention group receiving e-learning on alcohol use in pregnancy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a physician (gynecologist or obstetrician), midwife, social worker or other health professional working in maternity care
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Annette Binder, Dr. med.

    University Hospital Tübingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Two groups are included: one intervention group and one waitlist-control group. Both groups complete baseline questionnaires, then the intervention group receives the intervention (= gets access to the e-learning platform) and completes questionnaires afterwards. The waitlist control group first has a waiting period, then completes questionnaires again and then receives the intervention as an incentive. Afterwards the control group completes questionnaires again.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 21, 2026

Study Start

May 5, 2024

Primary Completion

January 5, 2025

Study Completion

January 5, 2025

Last Updated

August 21, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ANALYTIC CODE
Time Frame
After publication of the results of the primary outcome
Access Criteria
open access

Locations