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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Consumption
• Intervention / Treatment: Other: German Version of eCHECKUP TO GO

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 Type: Interventional
• Enrollment (Actual): 1465
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Esslingen, Baden-Wuerttemberg, Germany, 73732
      • University of Applied Sciences Esslingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• any student

Exclusion Criteria:

• ongoing recuperation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eCHUG-D; 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.	Other: German Version of eCHECKUP TO GO; It is an online prevention program targeting alcohol consumption.
No Intervention: control; It is an assessment only condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Esslingen University of Applied Sciences
• Collaborators: Federal Ministry of Health, Germany
• Investigators: Principal Investigator: Thomas Heidenreich, PhD, University of Applied Sciences Esslingen

Publications and helpful links

General 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

• Last Update Posted (Estimate): December 14, 2015
• Last Update Submitted That Met QC Criteria: December 11, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: alcohol consumption; binge drinking; web-based personalized feedback program; students
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: IIA5-2513DSM213

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No