Trial document




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  DRKS00013273

Trial Description

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Title

Examination of components of the school-based prevention trial “Klar bleiben“ – a cluster-randomized controlled study

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Trial Acronym

KB17/18

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URL of the Trial

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Brief Summary in Lay Language

Alcohol use among adolescents remains a serious risk for healthy development: adolescents that practice binge drinking or heavy episodic drinking are at greater risk to experience organ damage, accidents, and develop alcohol dependence. The school-based prevention program "Klar bleiben" (=”Stay clearheaded”) for grade 10 classes consists of a class commitment to refrain from binge drinking for nine weeks.
An efficacy-oriented cluster-randomized controlled trial has shown that binge drinking was significantly reduced among adolescents, who had previously consumed alcohol compared to a control group (DRKS-ID: DRKS00009424).
The current study aims to investigate determining factors of “Klar bleiben” leading to this effect. Thus, a total of 300 schools will be invited, and randomly allocated to one of the following three treatment arms:
• “Klar bleiben” as a class commitment plus teaching materials (arm 1)
• “Klar bleiben” as a class commitment (arm 2)
• Control group, not participating in “Klar bleiben” (arm 3)
Each treatment arm is planned to comprise 80 classes. To investigate potential age-related effects, classes range from 9th to 11th grade. All participating classes will be asked to report the extent of their alcohol consumption prior to the intervention, post-intervention, and – if accessible – at 12-month follow-up after the intervention. Furthermore, teachers of intervention classes (arm 1, and arm 2) will be asked to continuously document and evaluate the implementation of “Klar bleiben”.
For participating in this study, each class will receive 50 euros per data assessment. Teachers that participate in the study will receive book store gift certificates (25 euros).
Similar to the first efficacy trial, successful classes that refrain from binge drinking for nine weeks are awarded prizes by random draw.

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Brief Summary in Scientific Language

Background and study aims:
Hazardous alcohol use is common among adolescents, in particular binge drinking or heavy episodic drinking, and it is linked to manifold negative consequences, such as increased risks for injuries, accidents, and alcohol dependence. As of today, school-based prevention programs targeting hazardous alcohol use have achieved mixed results (Cochrane Database Syst Rev. 2011: CD009113).
However, a cluster-randomized trial has shown effects of the school-based prevention program “Klar bleiben”, in that adolescents who had previously consumed alcohol drank alcohol less often and in smaller amounts than their counterparts in the control group (DRKS-ID: DRKS00009424). The current study aims to investigate which components of “Klar bleiben” are responsible for this effect.

Intervention:
The prevention program “Klar bleiben”(=“Stay clearheaded“) addresses primarily grade 10 students. It aims to prevent and reduce hazardous drinking patterns like binge drinking or heavy episodic drinking among adolescents, and to encourage them in drinking responsibly. The current study implements two versions of “Klar bleiben” (arm 1 and arm 2). Arm 1 of “Klar bleiben” consists of the following elements:
• Participating classes commit themselves by contract management to renounce hazardous drinking patterns for nine weeks (January to March 2018)
• Students in these classes report their drinking behavior on a regular basis (every fortnight). Their contract states that at least 90 % of all students shall not practice hazardous drinking. Each report serves as validation for the initial commitment
• At the end of the nine-week period, classes that complied with their commitment will be awarded prizes by random draw
• Teaching materials focus alcohol use in adolescence from an array of perspectives that may be included in different school subjects
• Informational material for these intervention classes further consists of booklets for teachers, and parents, covering topics such as implications for successful alcohol-related communication between parent and child
Arm 2 of “Klar bleiben” is identical to arm 1 except the implementation of teaching materials:

Methods:
The evaluation of this program will be conducted as a three-arm cluster-randomized trial. In addition to both intervention arms, a control arm (arm 3) will be implemented. Students in the control group will not participate in “Klar bleiben”, but will rather receive “education as usual”. In sum, 300 schools are to be invited, and randomly allocated to the treatment arms (resulting in 80 classes per treatment arm). The study sample consists of approximately 4800 students from secondary schools in North Rhine-Westphalia. To examine potential age-related effects, the sample includes students from 9th, 10th, and 11th grade. Students of both intervention groups participate in „Klar bleiben” (January – March 2018). All three study groups take part in three surveys: one prior to the prevention program (November-December 2017), one after the prevention program (April-May 2018), and – if accessible – one follow-up assessment, 12 months after implementation of the program (April-May 2019). These surveys will focus on the participants’ drinking behavior. The surveys will be conducted simultaneously in all three groups. Moreover, teachers of intervention classes will be asked to continuously document and evaluate the implementation of “Klar bleiben”.
The self-report based surveys will be administered by trained teaching staff. Each survey will take about 20 minutes and will be conducted anonymously. To connect the assessments to one another, a seven-digit individual code generated by the students will be used. This code does not reveal any information on the identity of the participants.
For participating in this study, each class will receive 50 euros per data assessment. Teachers that participate in the study will receive book store gift certificates (25 euros).
All collected data will be treated confidentially. Data will be scanned, saved and analyzed via computational software. It will not be analyzed on an individual level. Moreover, all participants have the right to revoke their consent and ask that their personal data be deleted at any time.

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Organizational Data

  •   DRKS00013273
  •   2017/11/03
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  •   yes
  •   Approved
  •   RH 072017, Ethikkommission der Deutschen Gesellschaft für Psychologie Vorsitz: Prof. Dr. Claudia Friedrich https://www.dgps.de/index.php?id=185
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Secondary IDs

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Health Condition or Problem studied

  •   F10 -  Mental and behavioural disorders due to use of alcohol
  •   alcohol use
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Interventions/Observational Groups

  •   Participation in the school-based prevention program ‘Klar bleiben’-version 1 self commitment and teaching units: classes commit themselves to abstain from binge drinking and hazardous forms of alcohol use for a period of 9 weeks via contract management, monitoring of the commitment, reward of compliance by prizes; four teaching units on alcohol use in adolescence. Three data assessments, one pre- and one post-interventional, and one follow-up 12 months after the intervention
  •   Participation in the school-based prevention program ‘Klar bleiben’-version 2 only self commitment, no teaching units: classes commit themselves to abstain from binge drinking and hazardous forms of alcohol use for a period of 9 weeks via contract management, monitoring of the commitment, reward of compliance by prizes. Three data assessments, one pre- and one post-interventional, and one follow-up 12 months after the intervention
  •   Control: na participation in the school-based prevention program "Klar bleiben", i. e. education as usual. Three data assessments at the same time like the intervention groups.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group), Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Frequency and intensity of binge drinking/heavy episodic drinking, assessed by questionnaire / self report at each assessment (Pre, Post, 12 months follow-up): Frequency of binge drinking ever and in the last 30 days? In case of binge drinking: How many units of alcohol?

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Secondary Outcome

Frequency and intensity of alcohol use, assessed by questionnaire / self report at each assessment (Pre, Post, 12 months follow-up): Frequency of alcohol use ever and in the last 30 days? In case of alcohol use: How many units of alcohol?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/11/15
  •   4800
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Students from grade 9, 10 or higher

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Exclusion Criteria

Students from grades <9

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Therapie- und Gesundheitsforschung IFT-Nord gGmbH
    • Mr.  Prof. Dr.  Reiner  Hanewinkel 
    • Harmsstr. 2
    • 24114  Kiel
    • Germany
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    • Institut für Therapie- und Gesundheitsforschung IFT-Nord gGmbH
    • Mr.  Prof. Dr.  Reiner  Hanewinkel 
    • Harmsstr. 2
    • 24114  Kiel
    • Germany
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    • Institut für Therapie- und Gesundheitsforschung IFT-Nord gGmbH
    • Mr.  Prof. Dr.  Reiner  Hanewinkel 
    • Harmsstr. 2
    • 24114  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Bundeszentrale für gesundheitliche Aufklärung
    • Ms.  Michaela  Goecke 
    • Maarweg 149-161
    • 50825  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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