Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English 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,
Miss Susan Andersen,

Trial website

Contact information



Primary contact

Dr Liselotte Ingholt


Contact details

Øster Farimagsgade 5a

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

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


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

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

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet


School wellbeing, physical and psychological wellbeing , smoking and school attainment


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.

Intervention type



Not Applicable

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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.

Participant type


Age group




Target number of participants

Approximately 6400 students in total

Participant exclusion criteria

Students following special education programs that lead to a higher degree of education

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Øster Farimagsgade 5a, 2.

Sponsor information


Tryg Foundation (TrygFonden) (Denmark)

Sponsor details

Lyngby Hovedgade 4
2. sal
Kgs. Lyngby

Sponsor type




Funder type


Funder name

Tryg Foundation (TrygFonden) (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in

Publication citations

Additional files

Editorial Notes

22/12/2015: Publication reference added.