Trial document




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  DRKS00000214

Trial Description

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Title

Saving and Empowering Young Lives in Europe: promoting health through the prevention of risk-taking and self-destructive behaviours

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Trial Acronym

SEYLE

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URL of the Trial

http://www.seyle.org

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Brief Summary in Lay Language

SEYLE is a health promoting programme for adolescents in European schools. Its main objectives are to lead adolescents to better health through decreased risk taking and suicidal behaviours, to evaluate outcomes of different preventive programmes and to recommend effective culturally adjusted models for promoting health of adolescents in different European countries.

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Brief Summary in Scientific Language

In this health promotion programme, a pilot intervention study will be implemented to access the effects of three different health promoting/suicide preventing programmes in 11,000 pupils across 11 European countries. The key risks concerning unhealthy lifestyles identified in adolescents include suicide behaviours, violence, substance or alcohol abuse, promiscuous sexual behaviours, poor diet, lack of exercise and smoking. The four interventions are:

Arm I: QPR Intervention: QPR stands for Question, Persuade, and Refer, which teaches lay and professional gatekeepers (teachers, school staff, etc.) to recognize and refer students, exhibiting suicide warning signs and mental health problems, to treatment.

Arm II: Awareness Intervention: All pupils will be provided a specifically tailored didactic and awareness-increasing booklet (including telephone numbers and emails to a facilitator), six posters and lectures addressing topics on healthy lifestyles, stress, crisis, depression and suicidal behaviour, which will be implemented in the following format: During the class, the instructor will distribute the booklets to all the students, including the strategic placement of all six posters within the classroom. The material will include the same contents regarding the topics described above. The instructor will then proceed in lecturing on these topics, while students engage with the booklets and posters surrounding the classroom.

Arm III: Screening by Professionals: with help of data from baseline instruments, the presence of depression, anxiety, suicidal behaviour, unhealthy behaviours, and other mental health problems will be detected, and pupils who are considered to be critically at risk will be referred to onsite clinical evaluation and assessment performed by a professional. The clinical interview assessment will determine those students who have mental health problems and refer them to a healthcare provider for further treatment, while residual students will be dismissed from screening.

Arm IV: Control Group/Minimal Intervention: This intervention will comprise didactic posters, which are strategically hanged on the walls in the classroom. Students who, through these posters, self-recognize the need for help will have the opportunity to contact a training group on healthy lifestyle and/or a healthcare provider.

Key objectives of the study are to:

Gather information on health and well-being in European adolescents (data on healthy and at risk lifestyles and relationship with well-being, depression and suicide, data on pupils perceptions and attitudes towards health promoting and risk taking behaviours).

Perform interventions on adolescents leading to better health through decreased risk taking and suicidal behaviours by comparing the three intervention strategies.

Multidisciplinary evaluation (social, psychological and financial) outcomes of the interventions in comparison with a control group (efficacy, maintenance, effectiveness and cost-effectiveness of programmes).

Recommend effective anthropologically and culturally adjusted models for promoting the health of adolescents in Europe (provide evidenced based information for prevention programmes, increase awareness to policy makers, professionals and parents, and to young people).

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Organizational Data

  •   DRKS00000214
  •   2009/10/27
  •   [---]*
  •   no
  •   Approved
  •   S-380/2008, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1112-3194 
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Health Condition or Problem studied

  •   R45.8 -  Other symptoms and signs involving emotional state
  •   F32.9 -  Depressive episode, unspecified
  •   F19.1 -  Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances; Harmful use
  •   F10.1 -  Mental and behavioural disorders due to use of alcohol; Harmful use
  •   F41.9 -  Anxiety disorder, unspecified
  •   R45.6 -  Physical violence
  •   F91 -  Conduct disorders
  •   F90.0 -  Disturbance of activity and attention
  •   Z55-Z65 -  Persons with potential health hazards related to socioeconomic and psychosocial circumstances
  •   Z72.8 -  Other problems related to lifestyle
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Interventions/Observational Groups

  •   Arm I: QPR Intervention: QPR stands for Question, Persuade, and Refer, which teaches lay (parents, etc.) and professional gatekeepers (teachers, school staff, etc.) to recognize and refer students, exhibiting suicide warning signs and mental health problems, to treatment.
  •   Arm II: Awareness Intervention: All pupils will be provided a specifically tailored didactic and awareness-increasing booklet (including telephone numbers and emails to a facilitator), six posters and lectures addressing topics on healthy lifestyles, stress, crisis, depression and suicidal behaviour, which will be implemented in the following format: During the class, the instructor will distribute the booklets to all the students, including the strategic placement of all six posters within the classroom. The material will include the same contents regarding the topics described above. The instructor will then proceed in lecturing on these topics, while students engage with the booklets and posters surrounding the classroom.
  •   Arm III: Screening by Professionals: with help of data from baseline instruments, the presence of depression, anxiety, suicidal behaviour, unhealthy behaviours, and other mental health problems will be detected, and pupils who are considered to be -critically at risk- will be referred to onsite clinical evaluation and assessment performed by a professional. The clinical interview assessment will determine those students who have mental health problems and refer them to a healthcare provider for further treatment, while residual students will be dismissed from screening.
  •   Arm IV: Control Group/Minimal Intervention: This intervention will comprise didactic posters hanged strategically on the walls in the classroom. Students who, through these posters, self-recognize the need for help will have the opportunity to contact a training group on healthy lifestyle and/or a healthcare provider.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Single blind
  •   data analyst
  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

In each arm, the primary outcome is to measure the number of referrals, number of attempted suicides, and number of completed suicides, suicidal ideation and general well-being

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Secondary Outcome

Attitudes;
Lifestyles;
Depression;
Anxiety;
Alcohol use and abuse;
Drugs use and abuse;
Eating habits;
BMI;
Physical activity;
Sexual habits;
Tobacco use;
Violent behaviors;
Risky behaviours;
Emotional symptoms;
Conduct problems;
Hyperactivity/inattention;
Peer relationship problems;
Prosocial behavior;
Values (religion, family, marriage, work, friendship);
Coping;
General child health;
Peer relations;
Child-parent relations;
Stigma and discrimination;
Future outlook;
Self-harm behavior;

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Countries of Recruitment

  •   Germany
  •   Estonia
  •   France
  •   Hungary
  •   Ireland
  •   Israel
  •   Italy
  •   Romania
  •   Slovenia
  •   Spain
  •   Austria
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/11/15
  •   11000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   14   Years
  •   16   Years
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Additional Inclusion Criteria

School-based adolescents in the study area(s) is eligible to participate if it meets all the following criteria:
1. Adolescents attend a Public school that is non-specialized;
2. Each school contains at least 40 students age 15 years old;
3. Has more than two (3+) teachers for students age 15 years old;
4. No more than 60% of students are the same gender;
5. Informed consent of parents and students

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Exclusion Criteria

If the school-based adolescents meet the following exclusion criteria, they are ineligible to participate:
1. Adolescents that attend a specialized and/or private schools;
2. Adolescents attending single gendered schools;
3. Schools with less than 40 students aged 15 years.

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Addresses

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    • Karolinska Institut
    • Ms.  Prof. Dr.  Danuta  Wassermann 
    • 171 77  Stockholm
    • Sweden
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Klinik für Kinder- und Jugendpsychiatrie, Zentrum für psychosoziale Medizin, Universitätsklinikum Heidelberg
    • Mr.  Dr. med.  Michael  Kaess 
    • Blumenstr. 8
    • 69115  Heidelberg
    • Germany
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    • Klinik für Kinder- und Jugendpsychiatrie, Zentrum für psychosoziale Medizin, Universitätsklinikum Heidelberg
    • Mr.  Dr. med.  Michael  Kaess 
    • Blumenstr. 8
    • 69115  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • European Commission
    • Mr.  Dr.  Gesa  Hansen 
    • DG RTD-F6
    • B-1049  Brussels
    • Belgium
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Status

  •   Recruiting complete, follow-up complete
  •   2012/01/31
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.