Alcohol ConsumptionPsStNCT02453971
Trial to Evaluate the Effects of the German eCHECKUP TO GO in Students
A study testing German Version of eCHECKUP TO GO in people with Alcohol Consumption, run by Esslingen University of Applied Sciences at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the effects of the German eCHECKUP TO GO (eCHUG-D) in students. Compared to the control group subjects who conducted eCHUG-D should have less alcohol consumption and less alcohol associated problems after three and six months. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- German Version of eCHECKUP TO GO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,465 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Dec 2015
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- any student
Who cannot join
- ongoing recuperation
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Applied Sciences Esslingen
Esslingen am Neckar, Baden-Wurttemberg, 73732
About this study
Official title: German Title: Prävention Substanzbezogener Störungen Bei Studierenden
The purpose of this study is to evaluate the effects of the German eCHECKUP TO GO (eCHUG-D) in students. Compared to the control group subjects who conducted eCHUG-D should have less alcohol consumption and less alcohol associated problems after three and six months.
Read the detailed description
The effectivity of the eCHUG-D will be checked through a prospective randomized-controlled web-study.
All students at the participating universities will be informed about the PsSt-study. They have to agree to the informed consent to take part in the study. A missing agreement leads to exclusion. All subjects get an individual random login-code for study participation. After random assignment (intervention (eCHUG-D) vs. control group) all subjects have to answer the same web-questionnaires about their alcohol consumption (see outcome variables). Subjects of the intervention group are then requested to conduct eCHUG-D and to fill in their login-code at the end of the program.
The 3-month and 6-month follow-ups contain similar questions about alcohol consumption and alcohol related consequences. On 6-month follow-up additional questions ask about the acceptance of eCHUG-D (intervention group) and the acceptance of the study in general (control condition).
Earlier studies showed the effectiveness of eCHUG in US college samples. The primary endpoint of the study ist the amount of alcohol consumed. We hypothesize that the eCHUG group will show significantly lower levels of alcohol intake than the control group
- Conditions
- Alcohol Consumption
- Being tested
- German Version of eCHECKUP TO GO
- Keywords
- alcohol consumption, binge drinking, web-based personalized feedback program, students
- Medical subject headings
- Alcohol Drinking, Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
German Version of eCHECKUP TO GOOther
It is an online prevention program targeting alcohol consumption.
| Study group | Role | What they receive |
|---|---|---|
| eCHUG-D | Experimental | The eCHUG group is requested to conduct the German Version of eCHECKUP TO GO and to fill in their code on the last page of the program. Receives: Other: German Version of eCHECKUP TO GO |
| control | No intervention | It is an assessment only condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity-Frequency Questions (Alcohol Consumption)
Quantity of standard drinks during the last month and frequency of binge drinking occasions during the last month.
Measured: 3-month
Quantity-Frequency Questions (Alcohol Consumption)
Quantity of standard drinks during the last month and frequency of binge drinking occasions during the last month.
Measured: 6-month
Secondary outcomes (4)
Maximum Blood Alcohol Concentration (BAC)
Estimation of BAC using the Widmark formula for the occasion during the past month when somebody drank the most.
Measured: 3-month
Maximum Blood Alcohol Concentration (BAC)
Estimation of BAC using the Widmark formula for the occasion during the past month when somebody drank the most.
Measured: 6-month
Rutgers Alcohol Problem Index (RAPI) (18-Item Version)
The RAPI is a 18-item self-administered screening tool for assessing adolescent problem drinking. Categorical answering is requested for consequences of alcohol use (0 = None,1 = 1-2 times, 2 = 3-5 times, 3 = More than 5 times). The RAPI is scored on a scale of 0-54.
Measured: 3-month
Rutgers Alcohol Problem Index (RAPI) (18-Item Version)
The RAPI is a 18-item self-administered screening tool for assessing adolescent problem drinking. Categorical answering is requested for consequences of alcohol use (0 = None,1 = 1-2 times, 2 = 3-5 times, 3 = More than 5 times). The RAPI is scored on a scale of 0-54.
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esslingen University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Ministry of Health, Germany
- Responsible party
- Sponsor
- Investigators
- Thomas Heidenreich, PhD, Principal investigator, Esslingen University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453971
- Sponsor's protocol ID
- IIA5-2513DSM213
- Acronym
- PsSt
- Status last verified
- Jun 2015
- First submitted
- 7 May 2015
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sobell, L. C., & Sobell, M. B. (2004). Alcohol consumption measures. In National Institute on Alcohol Abuse and Alcoholism, Assessing alcohol problems: A guide for clinicians and researchers (pp. 75-100). Bethesda, MD: Author.
White HR, Labouvie EW. Towards the assessment of adolescent problem drinking. J Stud Alcohol. 1989 Jan;50(1):30-7. doi: 10.15288/jsa.1989.50.30.
PubMed 2927120
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German Title: Prävention Substanzbezogener Störungen Bei Studierenden
- ClinicalTrials.gov ID
- NCT02453971
- Acronym / sponsor ID
- PsSt / IIA5-2513DSM213
- Conditions
- Alcohol Consumption
- Keywords
- alcohol consumption, binge drinking, web-based personalized feedback program, students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,465 participants (actual)
- Lead sponsor
- Esslingen University of Applied SciencesUniversity, hospital or other
- Collaborators
- Federal Ministry of Health, Germany
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 May 2015 (estimated)
- 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.
The purpose of this study is to evaluate the effects of the German eCHECKUP TO GO (eCHUG-D) in students. Compared to the control group subjects who conducted eCHUG-D should have less alcohol consumption and less alcohol associated problems after three and six months.
Detailed description
The effectivity of the eCHUG-D will be checked through a prospective randomized-controlled web-study.
All students at the participating universities will be informed about the PsSt-study. They have to agree to the informed consent to take part in the study. A missing agreement leads to exclusion. All subjects get an individual random login-code for study participation. After random assignment (intervention (eCHUG-D) vs. control group) all subjects have to answer the same web-questionnaires about their alcohol consumption (see outcome variables). Subjects of the intervention group are then requested to conduct eCHUG-D and to fill in their login-code at the end of the program.
The 3-month and 6-month follow-ups contain similar questions about alcohol consumption and alcohol related consequences. On 6-month follow-up additional questions ask about the acceptance of eCHUG-D (intervention group) and the acceptance of the study in general (control condition).
Earlier studies showed the effectiveness of eCHUG in US college samples. The primary endpoint of the study ist the amount of alcohol consumed. We hypothesize that the eCHUG group will show significantly lower levels of alcohol intake than the control group
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eCHUG-D | Experimental | Other: German Version of eCHECKUP TO GOThe eCHUG group is requested to conduct the German Version of eCHECKUP TO GO and to fill in their code on the last page of the program. |
| control | No intervention | –It is an assessment only condition. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- any student
Key exclusion criteria (1 listed)
- ongoing recuperation
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 |
|---|---|---|
| German Version of eCHECKUP TO GOIt is an online prevention program targeting alcohol consumption. | Other | eCHUG-D |
Primary outcome
Quantity-Frequency Questions (Alcohol Consumption)
Time frame: 3-month
Quantity of standard drinks during the last month and frequency of binge drinking occasions during the last month.
Quantity-Frequency Questions (Alcohol Consumption)
Time frame: 6-month
Quantity of standard drinks during the last month and frequency of binge drinking occasions during the last month.
4 secondary outcomes
Maximum Blood Alcohol Concentration (BAC)
Time frame: 3-month
Maximum Blood Alcohol Concentration (BAC)
Time frame: 6-month
Rutgers Alcohol Problem Index (RAPI) (18-Item Version)
Time frame: 3-month
Rutgers Alcohol Problem Index (RAPI) (18-Item Version)
Time frame: 6-month
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 14 Dec 2015.
- BackgroundSobell, L. C., & Sobell, M. B. (2004). Alcohol consumption measures. In National Institute on Alcohol Abuse and Alcoholism, Assessing alcohol problems: A guide for clinicians and researchers (pp. 75-100). Bethesda, MD: Author.
- Background: PubMed 2927120White HR, Labouvie EW. Towards the assessment of adolescent problem drinking. J Stud Alcohol. 1989 Jan;50(1):30-7. doi: 10.15288/jsa.1989.50.30.
- Link to the original web-site of the eCHUG and its contact information.Link provided by the sponsor.
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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.
Thomas Heidenreich, PhD principal investigator
Esslingen University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing German Version of eCHECKUP TO GO in people with Alcohol Consumption, run by Esslingen University of Applied Sciences 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 1 inclusion and 1 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 14 Dec 2015. 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?
Quantity-Frequency Questions (Alcohol Consumption) (time frame: 3-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02453971, which also lists 2 linked publications.
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 14 Dec 2015.