Trial document




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  DRKS00014693

Trial Description

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Title

Pro-HEAD - Promoting Help-seeking using E-technology for ADolescents. Subproject 5: Mental Health Promotion: Universal School-Based Prevention for Healthy Adolescents Using Online or Face-to-Face Interventions

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Trial Acronym

Pro-HEAD Teilprojekt 5

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URL of the Trial

http://www.prohead.de

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Brief Summary in Lay Language

The consortium Pro-HEAD "Promoting Help-seeking using E-technology for ADolescents" aims to develop, implement and evaluate specific E-mental health tools and Internet based interventions that are capable to enhance help-seeking of children and adolescents with mental health problems; and can prevent mental health problems in both healthy and high-risk children and adolescents. This trial description refers to Pro-HEAD subproject 5.
Subproject 5 has a distinct focus on healthy children and adolescents and adds a universal health promotion approach. The main objective of sub-project 5 are related to the development, implementation, and evaluation of a universal school-based prevention program named StresSOS that aims to improve mental health literacy and stress management in healthy adolescents. Healthy adolescents will either take part in a face-to-face intervention at school, in an online intervention at home, or in an online placebo-control group. Subproject 5 investigates the efficacy of the Internet-delivered StresSOS (compared to an active online control condition; Study A), and non-inferiority of online delivery to face-to-face delivery (Study B) with regard to a reduction of new incidence mental health problems in children and adolescents. Participants are healthy students (without mental health problems in an initial school-based screening) in grades 6 to 13, aged 12 to 19.

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Brief Summary in Scientific Language

The aim is to strengthen mental health in healthy adolescents based on the life skills approach. Thus, a universal school-based prevention program named StresSOS for healthy adolescents is being developed, implemented, and evaluated. The contents focus on stress management and mental health literacy; they are implemented in eight weekly units, Internet-based (20 to 90 minutes each) or face-to-face (90 minutes each). Healthy adolescents will either take part in a face-to-face intervention at school, in an online intervention at home, or in an online placebo-control group at home (online program on healthy nutrition). Participants in both intervention groups (online or face-to-face) will receive the same treatment modules. In two randomized-controlled studies, effectiveness, cost-effectiveness and acceptance of the online intervention StresSOS are tested by means of pre-, post- and follow-up assessments. Study A examines the online intervention StresSOS in comparison to the online placebo control condition; study B the non-inferiority of the StesSOS online format in comparison to the face-to-face condition. Participants are healthy students (without mental health problems in an initial school-based screening) in grades 6 to 13, aged 12 to 19. The primary outcome variable in both studies A and B is the proportion of healthy children and adolescents who maintained good mental health (i.e. non-transit from healthy to the high-risk or the mental health problems-group) at 1-year follow-up. In addition, coping strategies, stress-related symptoms, health-related quality of life, knowledge about stress, coping and mental health, attitudes towards mentally ill people, help-seeking, program acceptance, program use parameters and cost efficiency are evaluated.

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Organizational Data

  •   DRKS00014693
  •   2018/05/14
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  •   yes
  •   Approved
  •   S-086/2018, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   F90-F98 -  Behavioural and emotional disorders with onset usually occurring in childhood and adolescence
  •   Stress
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Interventions/Observational Groups

  •   Intervention Group Online: Online prevention program StresSOS for stress management and mental health literacy: Eight weekly sessions of 20 to 90 minutes each. Contents of the training are well-being and stress; stressors and problem solving; mental strategies; recovery and relaxation; spiral of feelings; social support; mental health and illness.
  •   Intervention group face-to-face: Participation in the prevention programme StresSOS on stress management and mental health literacy as part of school classroom instruction: eight weekly units of 90 minutes each. Contents of the training are (parallel to the online program) well-being and stress; stressors and problem solving; mental strategies; recovery and relaxation; spiral of feelings; social support; mental health and illness. Supervision by trained trainers (with completed/advanced studies in psychology, teaching qualification or health promotion).
  •   Control Group Online: Participation in the online prevention programme on healthy nutrition: eight 20- to 90-minute sessions over a period of eight weeks. The contents of the training are oriented towards the rules of healthy nutrition according to the DGE (German Nutrition Society) (e.g. nutrients and energy; fruit and vegetables; bread, cereals and potatoes; dairy products, meat, fish and eggs; food variety; drinks; breakfast; food on the way).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome variable in both studies A and B is the number of children and adolescents who will not transit from the healthy to the “high-risk”- or “mental health problems”-group at 12 months follow-up. Assesments take place within the school-based initial screening and at 1- and 2-year school-based followed-ups.

Instrument used (e.g.):
SDQ – Strengths and Difficulties Questionnaire, German version
WCS – Weight Concerns Scale,German Version
SEED – Short Evaluation of Eating Disorders, German version
CRAFFT – Car, Relax, Alone, Forget, Friends, Trouble Test, German Version
PHQ-A – Patient Health Questionnaire for Adolescents, German version


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Secondary Outcome

Secondary outcome variables are coping, health related quality of life, MHL, knowledge about stress, coping, attitudes towards mental health problems,help-seeking attitudes, symptoms of stress, self-esteem, acceptance, utilization, and cost of programs. These are assessed partly in a program-specific pre- and post-line and partly within the school-based screening at intervals of 12 and 24 months.

Instrument used (e.g.):
SSKJ 3-8 R – Stress and Coping Questionnaire for Children and Adolescents, German version;
Knowledge questions on stress, stress management and mental health;
Questions about participant satisfaction
KIDSCREEN 10, German version;
GHSQ – General Help-Seeking Questionnaire, German version;
Questionnaire on Social Distance (Short version), German version;
MRV – Mannheim module for resource consumption, German version
SEKJ - Inventory of Self-Esteem for Children and Adolescents

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • other 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/11/21
  •   5000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   12   Years
  •   19   Years
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Additional Inclusion Criteria

Students in grades 6 to 13 of the regular schools in the regions of Hamburg, Heidelberg, Leipzig, Marburg and Schwäbisch Gmünd (age: 12 to 19 years). The face-to-face sample is recruited in the Schwäbisch Gmünd region alone. No clinically or subclinically noticeable values in school-based screening: SDQ total score < 20, SDQ subscale emotional symptoms < 7, SDQ subscale hyperactivity/inattention < 7, SDQ subscale conduct problems < 5; WCS < 58, SEED Binge = 0, SEED Vomit = 0, CRAFFT < 2 and PHQ-A < 5.

SDQ – Strengths and Difficulties Questionnaire, deutsche Version
WCS – Weight Concerns Scale, deutsche Version
SEED – Short Evaluation of Eating Disorders, deutsche Version
CRAFFT – Car, Relax, Alone, Forget, Friends, Trouble Test, deutsche Version
PHQ-A – Patient Health Questionnaire for Adolescents, deutsche Version


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Exclusion Criteria

Not defined; if inclusion criteria are not fulfilled.

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Addresses

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    • Pädagogische Hochschule Schwäbisch Gmünd
    • Ms.  Prof. Dr.  Heike  Eschenbeck 
    • Oberbettringer Str. 200
    • 73525  Schwäbisch Gmünd
    • Germany
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    • Klinik für Kinder- und Jugendpsychiatrie, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr.  Michael  Kaess 
    • Blumenstraße 8
    • 69115  Heidelberg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf, Deutsches Zentrum für Suchtfragen
    • Mr.  Prof. Dr.  Rainer  Thomasius 
    • Martinistraße 52, W29
    • 20246  Hamburg
    • Germany
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    • Forschungsstelle für Psychotherapie (FOST), Universitätsklinikum Heidelberg, Institut für Psychosoziale Prävention
    • Ms.  PD Dr.  Stephanie  Bauer 
    • Bergheimer Straße 54
    • 69115  Heidelberg
    • Germany
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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universität Leipzig
    • Ms.  PD Dr.  Christine  Rummel-Kluge 
    • Semmelweisstraße 10
    • 04103  Leipzig
    • Germany
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    • AG Versorgungsforschung, Klinik für Psychiatrie und Psychotherapie, Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl.) Dr.  Hans-Joachim  Salize 
    • J 5
    • 68159  Mannheim
    • Germany
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    • Klinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie am "Universitätsklinikum Gießen und Marburg GmbH", Philipps-Universität Marburg, FB Medizin
    • Ms.  Prof. Dr.  Katja  Becker 
    • Hans-Sachs-Straße 6
    • 35039  Marburg
    • Germany
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    • Pädagogische Hochschule Schwäbisch Gmünd
    • Ms.  Prof. Dr.  Heike  Eschenbeck 
    • Oberbettringer Str. 200
    • 73525  Schwäbisch Gmünd
    • Germany
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    • Pädagogische Hochschule Schwäbisch Gmünd
    • Ms.  M. Sc.  Laya  Lehner 
    • Oberbettringer Str. 200
    • 73525  Schwäbisch Gmünd
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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