Alcohol Use During PregnancyELASNCT07778251
Effectiveness of an E-Learning Training on Addressing Alcohol Use During Pregnancy
A study testing Interprofessional e-Learning Program on Alcohol Use During Pregnancy in people with Alcohol Use During Pregnancy, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use During Pregnancy
- What is being tested?
- Interprofessional e-Learning Program on Alcohol Use During Pregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteGermany
- Study dates
- 5 May 2024to 5 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a physician (gynecologist or obstetrician), midwife, social worker or other health professional working in maternity care
- 18 years of age or older
- Sufficient German language skills
- Internet access
Who cannot join
- Not working in the before-named fields
- Younger than 18 years of age
- Insufficient German language skills
- No internet access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding, Supporting, Motivating - Together for an Alcohol-Free Pregnancy
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:
Read more
- 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.
- Conditions
- Alcohol Use During Pregnancy
- Being tested
- Interprofessional e-Learning Program on Alcohol Use During Pregnancy
- Keywords
- Pregnancy, Alcohol Use During Pregnancy, Medical Education, e-learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interprofessional e-Learning Program on Alcohol Use During PregnancyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
self-rated knowledge regarding risks and consequences of alcohol use during pregnancy. The variable is assessed on a 10-point Likert scale (0: no knowledge; 10: very high knowledge). This item was part of the web-based questionnaire.
Measured: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
communication skills
This outcome describes health professionals' self-rated communication skills in the professional context which means their perceived ability to have effective, sensitive, patient-centered conversation with their patients/clients. This variable is answered on a 4-point Likert scale (1: sufficient; 4 very good). It is also part of the web-based questionnaires.
Measured: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
confidence
This outcome measure describes health professionals' self-rated confidence in discussing alcohol use during pregnancy with pregnant women they face in their clinical routine. This item is answered on a 4-point Likert scale (1: very unconfident; 4: very confident) and also part of the web-based questionnaires.
Measured: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
actual conversation duration
Self-reported average actual duration (in minutes) of conversations on alcohol use during pregnancy. Also part of the web-based questionnaires.
Measured: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
desired conversation duration
self-reported desired duration (in minutes) on conversation on alcohol use in pregnancy. This should be an indicator of the perceived relevance of the topic. This variable is also assessed as part of the web-based questionnaires.
Measured: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start5 May 2024
- Primary completion5 Jan 2025
- Study completion5 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use During PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annette Binder, Dr. med., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778251
- Sponsor's protocol ID
- 067/2024BO1
- Other IDs
- Z2/21.30.11/23
- Acronym
- ELAS
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding, Supporting, Motivating - Together for an Alcohol-Free Pregnancy
- ClinicalTrials.gov ID
- NCT07778251
- Acronym / sponsor ID
- ELAS / 067/2024BO1
- Conditions
- Alcohol Use During Pregnancy
- Keywords
- Pregnancy, Alcohol Use During Pregnancy, Medical Education, e-learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 5 Jan 2025 (actual)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group receiving e-learning on alcohol use in pregnancy | Experimental | Behavioral: Interprofessional e-Learning Program on Alcohol Use During PregnancyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being a physician (gynecologist or obstetrician), midwife, social worker or other health professional working in maternity care
- 18 years of age or older
- Sufficient German language skills
- Internet access
Key exclusion criteria (4 listed)
- Not working in the before-named fields
- Younger than 18 years of age
- Insufficient German language skills
- No internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interprofessional e-Learning Program on Alcohol Use During PregnancyAn 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. | Behavioural | intervention group receiving e-learning on alcohol use in pregnancy |
Primary outcome
alcohol discussion proportion
Time frame: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
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.
5 secondary outcomes
knowledge on alcohol use in pregnancy
Time frame: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
communication skills
Time frame: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
confidence
Time frame: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
actual conversation duration
Time frame: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
desired conversation duration
Time frame: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Alcohol Use During Pregnancy
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Alcohol Use During Pregnancy
Recruiting
Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years
Alcohol-Related Disorders, Substance-Related Disorders
RecruitingObservational study
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Alcohol Drinking, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Binder, Dr. med. principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interprofessional e-Learning Program on Alcohol Use During Pregnancy in people with Alcohol Use During Pregnancy, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alcohol discussion proportion (time frame: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.