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

Primary Purpose

Alcohol Consumption

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
German Version of eCHECKUP TO GO
Sponsored by
Esslingen University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Consumption focused on measuring alcohol consumption, binge drinking, web-based personalized feedback program, students

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • any student

Exclusion Criteria:

  • ongoing recuperation

Sites / Locations

  • University of Applied Sciences Esslingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

eCHUG-D

control

Arm Description

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.

It is an assessment only condition.

Outcomes

Primary Outcome Measures

Quantity-Frequency Questions (Alcohol Consumption)
Quantity of standard drinks during the last month and frequency of binge drinking occasions during the last month.
Quantity-Frequency Questions (Alcohol Consumption)
Quantity of standard drinks during the last month and frequency of binge drinking occasions during the last month.

Secondary Outcome Measures

Maximum Blood Alcohol Concentration (BAC)
Estimation of BAC using the Widmark formula for the occasion during the past month when somebody drank the most.
Maximum Blood Alcohol Concentration (BAC)
Estimation of BAC using the Widmark formula for the occasion during the past month when somebody drank the most.
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.
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.

Full Information

First Posted
May 7, 2015
Last Updated
December 11, 2015
Sponsor
Esslingen University of Applied Sciences
Collaborators
Federal Ministry of Health, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02453971
Brief Title
Trial to Evaluate the Effects of the German eCHECKUP TO GO in Students
Acronym
PsSt
Official Title
German Title: Prävention Substanzbezogener Störungen Bei Studierenden
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Esslingen University of Applied Sciences
Collaborators
Federal Ministry of Health, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption
Keywords
alcohol consumption, binge drinking, web-based personalized feedback program, students

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1465 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eCHUG-D
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
It is an assessment only condition.
Intervention Type
Other
Intervention Name(s)
German Version of eCHECKUP TO GO
Intervention Description
It is an online prevention program targeting alcohol consumption.
Primary Outcome Measure Information:
Title
Quantity-Frequency Questions (Alcohol Consumption)
Description
Quantity of standard drinks during the last month and frequency of binge drinking occasions during the last month.
Time Frame
3-month
Title
Quantity-Frequency Questions (Alcohol Consumption)
Description
Quantity of standard drinks during the last month and frequency of binge drinking occasions during the last month.
Time Frame
6-month
Secondary Outcome Measure Information:
Title
Maximum Blood Alcohol Concentration (BAC)
Description
Estimation of BAC using the Widmark formula for the occasion during the past month when somebody drank the most.
Time Frame
3-month
Title
Maximum Blood Alcohol Concentration (BAC)
Description
Estimation of BAC using the Widmark formula for the occasion during the past month when somebody drank the most.
Time Frame
6-month
Title
Rutgers Alcohol Problem Index (RAPI) (18-Item Version)
Description
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.
Time Frame
3-month
Title
Rutgers Alcohol Problem Index (RAPI) (18-Item Version)
Description
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.
Time Frame
6-month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: any student Exclusion Criteria: ongoing recuperation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Heidenreich, PhD
Organizational Affiliation
University of Applied Sciences Esslingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Applied Sciences Esslingen
City
Esslingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
73732
Country
Germany

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
PubMed Identifier
2927120
Citation
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.
Results Reference
background
Links:
URL
http://www.echeckuptogo.com
Description
Link to the original web-site of the eCHUG and its contact information.

Learn more about this trial

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

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