Trial document



drksid header

  DRKS00023788

Trial Description

start of 1:1-Block title

Title

„Meine Zeit ohne“: Prevention and health promotion at vocational schools with a focus on substance use and internet-related disorders

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

MZo

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

https://www.meine-zeit-ohne.de/

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Vocational school students represent an important target group for prevention and health promotion. They smoke more often than their peers and consume alcohol and cannabis more often at levels considered as problematic. Internet-related disorders are particularly common among young people of vocational school age. The use of evidence-based concepts and programs in the vocational school setting is underdeveloped compared to the general education system in Germany. In the general school system, prevention approaches have proven to be effective that are essentially based on a voluntary commitment to abstain from consumption. Within the current project this approach is transferred to the vocational school setting and expanded to include internet-related disorders. "Meine Zeit ohne" (MZo) is an app-based prevention program that was developed particularly for students of vocational schools. It promotes the exploration of one's own consumption behavior and thus a self-responsible and conscious use of substance and internet-related media use. At the center of the program is a "challenge". Participants voluntarily commit to abstain from or reduce an individually relevant habit (consumption of alcohol or cannabis, smoking, use of social media, computer games, gambling or similar) for two weeks. Facing this challenge offers the opportunity to experience and review one's own habits and explore alternative behavior. The goals of the study is to explore the effectiveness of the intervention and to find out whether the intervention has an addiction-preventive influence on vocational school students, e.g. whether the challenge changes the participants' consumption behavior or their attitudes towards substance and internet-media use. The project is being implemented in the three federal states of Schleswig-Holstein, Hamburg and Bavaria.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Background: Substance-related and addictive disorders are among the most common mental disorders in adolescence and young adulthood. Vocational school students represent an important target group for prevention and health promotion. Compared to their peers, they smoke more often and consume alcohol and cannabis more often in a problematic way. Internet-related disorders are particularly common among young people of vocational school age. The use of evidence-based concepts and programs in vocational school setting is underdeveloped compared to the general education system.
Method: In the general school system, prevention approaches have proven to be effective that are essentially based on a voluntary commitment to abstain from consumption. With the help of the MZo-App the vocational school students themselves determine which behavior or substance they want to abstain from for a period of 2 weeks: e.g. online and offline games, alcohol, cigarettes, cannabis etc. Participants use the app to give daily feedback on whether they have achieved their self-chosen goal.
The “Meine Zeit ohne” study (MZo) is planned as a pre-post cluster-randomized controlled trial with two arms, an intervention group (IG) and a waitlist control condition (CG) with two classroom-based online assessments. The vocational school classes represent the clusters. Randomization will occur on class level.
Students are included in the study if they meet the following criteria: 1. Signed informed consent 2. If under 16 years signed consent of a legal guardian. Reasons for exclusion are not prespecified.
The intervention consists of a two- week period of renouncement, assisted by the possibility to use the MZo smartphone application. Participants choose their own intervention goal which can be reducing or quitting the habitual consumption of a specific substance such as alcohol or nicotine or online behavior such as gaming or using social media. The intervention including the MZo-App will be made available to the control group after follow-up assessment.
Baseline data will be compared to a follow-up assessment, which occurs at least 30 days after participation in the intervention in the IG. The primary endpoints include the frequency and intensity of smoking, (risky) alcohol and cannabis consumption, and problematic Internet use. Secondary outcomes are symptoms of stress, depression, anxiety, physical activity and wellbeing. Further assessments concern sociodemographic information and process oriented outcomes.
With an expected reduction of the percentage of risky alcohol consumption among students in the intervention group compared to the control group of about 20%, an alpha level of 5% and a test strength of 0.80, the required sample is 1,950 persons (975 persons per group). With an estimated ICC of 0.032 and a number of about 20 students per class, i.e. per cluster, and a drop-out rate of about 20%, this results in a total target sample of at least 3,800 students from 190 classes.
The intervention effects are tested by means of logistic or linear multi-level regression with the levels classes and individual, whereby group and time variables as well as the interaction term group x time are used in addition to the group and time variables. Based on these models, adjusted frequencies and mean values are determined for the primary endpoints. Absolute and relative risk reduction is calculated as an indicator for the effect strength. In addition, age, gender, and migration background as well as the personality traits "sensation seeking" and impulsiveness, which have been shown in a large number of studies to be significant covariates of substance use and problematic use of the Internet, are recorded.
Objectives and expected benefit: With the present study, we aim to transfer the approach of voluntary commitment established in the general education system to the vocational school setting and to extend it to the area of Internet-related disorders. The aim of the study is the scientific evaluation of the feasibility and effectiveness of the program. This will be the first time that an evidence-based prevention program for the vocational school setting will be developed and evaluated and recommendations for its continuation and broad implementation will be derived.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

upon request completely anonymized data can be made available to other researchers for scientific purposes. Requests will be processed individually.

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00023788
  •   2021/01/20
  •   [---]*
  •   yes
  •   Approved
  •   LPEK-0121 , Lokale Psychologische Ethikkommission am Zentrum für Psychosoziale Medizin (LPEK) am Universitätsklinikum Hamburg-Eppendorf
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Prevention of substance use and media-related/ Internet-related disorders
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Experimental group: receives access to an app-based prevention program to support the achievement of an individual abstinence or reduction goal (e.g., habitual substance use or screen media use). Participants receive daily push messages over a 2-week period and document achievement or non-achievement of their abstinence or reduction goal.

  •   Waitlist control group: gets access to the app immediately after the post assessment.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Baseline-adjusted group comparison in substance and media use (frequency and amount, problematic use) measured in the postmeasurement.

Frequency and intensity of smoking, e-cigarette use, (risky) alcohol use, and cannabis use are recorded.

Dependent substance use is assessed in tobacco terms using the Fagerström Test for Nicotine Dependence (FTND, Heatherton et al., 1991), in alcohol terms using the Alcohol Use Disorder Identification Test-Consumption (AUDIT-C; Rumpf, 1999), and in cannabis terms using the Severity of Dependence Scale (SDS) (Gossop et al., 1995).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome


Stress, psych. well-being, life satisfaction, physical activity

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2021/02/01
  •   3800
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

students enrolled at vocational school

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

none

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Therapie- und Gesundheitsforschung
    • Mr.  Prof. Dr.  Reiner  Hanewinkel 
    • Harmsstr. 2
    • 24114  Kiel
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Deutsches Zentrum für Suchtfragen des Kindes- und Jugendalters am Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Dr.  Nicolas  Arnaud 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Institut für Therapieforschung
    • Ms.  Dr.  Kirsten  Lochbühler 
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Institut für Therapie- und Gesundheitsforschung
    • Mr.  PD Dr.  Matthis  Morgenstern 
    • Harmsstr. 2
    • 24114  Kiel
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Institut für Therapie- und Gesundheitsforschung
    • Mr.  PD Dr.  Matthis  Morgenstern 
    • Harmsstr. 2
    • 24114  Kiel
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Gesundheit (BMG)
    • Friedrichstraße 108
    • 10117   Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   [---]*
  •   [---]*
  •   2022/06/07
  •   4595
  •   4595
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.