Trial to Evaluate the Effects of the German eCHECKUP TO GO in Students

Alcohol Consumption Clinical Trial

— PsSt  

Official title:

German Title: Prävention Substanzbezogener Störungen Bei Studierenden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453971
• Other study ID #: IIA5-2513DSM213
• Status: Completed
• Phase: N/A
• First received: May 7, 2015
• Last updated: December 11, 2015
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: Esslingen University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1465
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• any student

Exclusion Criteria:

• ongoing recuperation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking

Intervention

Other:
• German Version of eCHECKUP TO GO
It is an online prevention program targeting alcohol consumption.

Locations

Country	Name	City	State
Germany	University of Applied Sciences Esslingen	Esslingen	Baden-Wuerttemberg

Sponsors (2)

Lead Sponsor	Collaborator
Esslingen University of Applied Sciences	Federal Ministry of Health, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity-Frequency Questions (Alcohol Consumption)	Quantity of standard drinks during the last month and frequency of binge drinking occasions during the last month.	3-month	No
Primary	Quantity-Frequency Questions (Alcohol Consumption)	Quantity of standard drinks during the last month and frequency of binge drinking occasions during the last month.	6-month	No
Secondary	Maximum Blood Alcohol Concentration (BAC)	Estimation of BAC using the Widmark formula for the occasion during the past month when somebody drank the most.	3-month	No
Secondary	Maximum Blood Alcohol Concentration (BAC)	Estimation of BAC using the Widmark formula for the occasion during the past month when somebody drank the most.	6-month	No
Secondary	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.	3-month	No
Secondary	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.	6-month	No

External Links

•   Link to the original web-site of the eCHUG and its contact information.