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Shaping the Social: Evaluating the effect of a complex intervention to promote wellbeing and educational attainment and reduce substance use among students in Danish vocational schools
ISRCTN ISRCTN57822968
DOI 10.1186/ISRCTN57822968
ClinicalTrials.gov identifier
EudraCT number
Public title Shaping the Social: Evaluating the effect of a complex intervention to promote wellbeing and educational attainment and reduce substance use among students in Danish vocational schools
Scientific title A controlled trial evaluating the effect of a complex intervention to promote wellbeing and educational attainment and reduce substance use among students in Danish vocational schools
Acronym N/A
Serial number at source N/A
Study hypothesis The aim of the study is to access the effect of a complex intervention on school wellbeing, physical and psychological wellbeing, smoking and school attainment.
The hypotheses:
1. Social and professional communities at the school have a positive impact on students' school well-being
2. Positive school well-being is important to keep students on training
3. Positive school well-being are associated with fewer somatic and psychological symptoms and positively associated with life satisfaction
4. Institutional structures affecting the formation of social communities are important for reducing smoking in school
Lay summary Background and study aims
Only half of all Danish students starting vocational training complete their programme. The largest drop-out occurs during basic training and 4 in 10 of those who drop out do not continue in education within ten years. Little is known of the health status of this particular group, but it is frequently reported that young people with a problematic pattern of substance abuse experience difficulties in completing an education. At vocational schools, improvements in institutionally anchored possibilities for socializing may reduce the risk of dropping out and prevent harmful substance use. Our goal is to develop, implement, and evaluate an intervention that works through changes in the institutional arrangements of vocational colleges. The aim of the study is to assess the effect of a complex intervention on school wellbeing, physical and psychological wellbeing, smoking and school attainment.

Who can participate?
The study aims to recruit students aged > 15 years, both boys and girls enrolled in basic vocational training at 10 schools across Denmark from October 2011 - October 2012.

What does the study involve?
The intervention works through changes in the institutional arrangements to improve possibilities for socializing and it is tested among students at four vocational schools. The comparison group consists of students at six vocational schools that continue with their usual practice. About 6,400 students answer questionnaires in the beginning of their vocational training and with follow up after about 10 weeks. To avoid non-response bias the data collection is performed at school. Follow-up of non-respondents is by mail, SMS and a letter. In addition, drop-out rates are tracked via national registers.

What are the possible benefits and risks of participating?
We expect the students in the intervention group to get a more consistent, predictable and socially anchored schooling. The school management and teachers at intervention schools need to engage in continuous collaboration with the researchers about the intervention.

Where is the study run from?
The Shaping the Social study has been set up by the Center for Intervention Research in Health Promotion and Disease Prevention, based at the National Institute of Public Health in Denmark, and is part of the Faculty of Health Sciences at the University of Southern Denmark. In collaboration with researchers at Centre for Alcohol and Drug Research at University of Aarhus, Unit for Health Promotion Research at University of Southern Denmark, Department of Psychosocial Research at The Danish Cancer Society and Department of Psychology and Educational Studies based at Roskilde University.

When is study starting and how long is it expected to run for?
The study starts in October 2011 and will run to January 2013. However, the study will extend beyond this as we intend to use national registers.

Who is funding the study?
The study is funded by Trygfonden, Denmark.

Who is the main contact?
Dr Liselotte Ingholt, liin@niph.dk
Miss Susan Andersen, sua@niph.dk
Ethics approval The study has been considered by the Danish Ethical Committee and they concluded that formal ethics approval was not required. This project is registered at the Danish Data Protection Agency (Datatilsynet) (ref: 2011-54-1265)
Study design Quasi-experimental design
Countries of recruitment Denmark
Disease/condition/study domain School wellbeing, physical and psychological wellbeing , smoking and school attainment
Participants - inclusion criteria Students (aged > 15 years, either sex) attending the basic course at one of the 10 participating vocational schools in the period between October 2011 to October 2012. The education and training programs consists of a basic and a main course. The following basic education and training programs are included: Building and construction (carpenter, bricklayer, painter, plumber), electrician, data technician, mechanic, food for human (e.g. cook, waiter), media (e.g. graphic designer, web integrator, sign writer), landscaping, farmer, greenhouse gardener.
Participants - exclusion criteria Students following special education programs that lead to a higher degree of education
Anticipated start date 01/10/2011
Anticipated end date 31/01/2013
Status of trial Completed
Patient information material Not available in web format, please use contact details to request a patient information sheet
Target number of participants Approximately 6400 students in total
Interventions The intervention comprises two areas aimed at:

1. First day at school: Here the programme focuses on activities that welcome new students, such as introduction of the students to the school, the education, the professional standard and the fellow students.
2. Everyday practice: Here the programme focuses on changes in everyday practice to integrate social activities and social ties with professional learning such as morning meetings, scheduled breaks, fewer possibilities for smoking, and a nook for hanging out during breaks.
The intervention programme is a tool to be used by school management and staff to initiate activities in the two areas. For each of the intervention areas, a number of mandatory and optional improvements will be implemented to either modify existing institutional structures or to establish new ones.

Comparison group consists of students at six vocational schools that continue with their usual practice.
Primary outcome measure(s) 1. School well-being measured at 10 weeks:
1.1 Positive relations with peers measured on items from Health Behaviour in School-aged Children (HBSC) questionnaire (Roberts et al. 2009; Currie et al. 2009).
1.2 Positive relations with teachers (HBSC items)
1.3 Engagement with and positive attitudes toward the school and the profession (based on HBSC questionnaire and new Shaping the Social items)
1.4 Connectedness to school (HBSC item)
2. Self-reported smoking measured at baseline, and at 10 weeks, and self-reported smoking in school measured at 10 weeks.
3. Dropout in basic course assessed by national registers measured at 1 year, also self-reported dropout measured at 10 weeks.
The Shaping the Social intervention is designed to create significant positive changes at follow-up versus baseline and between groups. School well-being is not measured at baseline because baseline data collection is performed at the first days of the student’s vocational training.
Secondary outcome measure(s) Secondary outcome measures measured at baseline, and at 10 weeks:
1. Physical and psychological well-being measured on the HBSC Symptom Check List (HBSC-SCL).
2. Loneliness measured on loneliness scale (four response categories)
3. Life satisfaction measured on Cantril Ladder Scale
Predefined unintended outcome measures measured at baseline, and at 10 weeks:
4. Self-reported alcohol consumption.
5. Self-reported drug use (cannabis and other drugs than cannabis (e.g. cocaine, amphetamine, ecstasy, steroids).

We will measure alcohol and drug consumption as side-effects but it is difficult to predict whether they will occur as unintended adverse or positive effects. Increased school wellbeing has a positive impact on alcohol and drug use. However, the literature also indicate that young people who have an active social life have more drunkenness-oriented drinking patterns and are experimenting more with drugs.
The primary and secondary outcome measures will be analyzed for sub populations defined by implementation level, age, parental socioeconomic status and the education and training programs.
Sources of funding Tryg Foundation (TrygFonden) (Denmark)
Trial website http://www.cirhp.dk/side.asp?side=8&id=15&ver=uk
Publications
Contact name Dr  Liselotte  Ingholt
  Address Øster Farimagsgade 5a, 2.
  City/town Copenhagen
  Zip/Postcode 1353
  Country Denmark
Sponsor Tryg Foundation (TrygFonden) (Denmark)
  Address Lyngby Hovedgade 4, 2. sal
  City/town Kgs. Lyngby
  Zip/Postcode 2800
  Country Denmark
  Sponsor website: http://www.trygfonden.dk/Om-TrygFonden/In-English
Date applied 30/12/2012
Last edited 16/01/2013
Date ISRCTN assigned 16/01/2013
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