Condition category
Mental and Behavioural Disorders
Date applied
27/02/2007
Date assigned
30/03/2007
Last edited
15/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.eudap.net

Contact information

Type

Scientific

Primary contact

Prof Fabrizio Faggiano

ORCID ID

Contact details

via Solaroli 17
Novara
28100
Italy
+39 (0)11 40188309
fabrizio.faggiano@med.unipmn.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

EU-Dap

Study hypothesis

In most European junior and senior high schools, some kind of intervention to protect against the use of alcohol, tobacco and drugs takes place. Most of these programs, however, have never been evaluated through a rigorous scientific methodology, which is a particularly serious problem. First of all, the theory about the nature of drug use is still weak, causing many interventions to be based on invalid principles. Next, efficacious evaluations completed so far have not drawn firm conclusions to base decisions. In some cases, merely the ability of the intervention to modify knowledge or a few skills was studied. In other cases, the methodology was unsound, for example there was no control group to make a comparison.

In the absence of substance use prevention programs with solid evidence of effectiveness, there is a need for sound evaluation of programs, especially in European countries. The EU-Dap project was created to fill this gap in knowledge.

The intervention program "Unplugged" was specifically designed for European schools, using principles and methods indicated in the scientific literature as being the most useful in reducing the prevalence of substance use.

The EU-Dap trial was designed in order to assess the effectiveness of the "Unplugged" program in preventing the use of tobacco, alcohol and drugs in European junior high schools.

The behaviors of the students regarding lifetime and past 30 days use of cigarettes, cannabis and other drugs; frequency of alcohol drinking and episodes of drunkenness were of interest of the study, as well as knowledge and opinions about substances, and social and personal skills.

Protocol can be found at http://www.eudap.net/PDF/EU-DAP%20Study%20Protocol%2020-6-04.pdf

Ethics approval

A general policy on informed consent was not adopted. Each center followed the practice required locally in order to obtain permission from the corresponding Ethical Boards.

Study design

Multi-centre cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Drug addiction

Intervention

The EU-Dap school prevention programme "Unplugged", targeted to 12-14 years old students, was designed to tackle both experimental and regular use of alcohol, tobacco and illicit drugs (for details, see www.eudap.net). It is based on a comprehensive social influence approach, incorporating aspects of normative education, general self-management, personal and social competence skills and knowledge enhancing classes. It was designed by an expert group including behavioural scientists and public health evaluators. The basic curriculum consists of 12 one-hour units to be delivered weekly by class teachers who previously attended a 2.5 days training course. In order to assess the role of parents and of age-peers in enhancing the effectiveness of the basic curriculum, this was delivered in three formats: basic curriculum alone (basic arm), or with the addition of side activities involving either peers (peers arm) or parents (parents arm). The curriculum and the additional components were delivered in the different countries in a very standardized way, concerning both content and the implementation procedures. For instance, the training course for the teachers participating in the programme was led by pedagogists who had received training on the programme during an international course held at the central level.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome of the study was defined through behavioural endpoints regarding the use of tobacco and drugs, and alcohol drinking.

Secondary outcome measures

Changes in knowledge, skills, attitudes and intention to use substances in the future were regarded as secondary outcomes.

Overall trial start date

15/09/2004

Overall trial end date

15/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

The study population consists of students 12 to 14 years of age, attending junior high grades in the administrative areas of the participating centers. Criteria for the selection of the age group were the usually low prevalence of substance use and the feasibility of two-years follow-up during compulsory school attendance. Inclusion criteria for the schools were:
1. Presence of at least two classes in the target grade
2. To be part of the mainstream national educational system (schools for students with special pedagogic needs and confessional schools were excluded)
3. Consent to participate
4. Not currently conducting structured interventions against substance use

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

165 schools, 330 classes, 6600 students

Participant exclusion criteria

Schools for students with special pedagogic needs and confessional schools, and schools currently conducting structured interventions against substance use were excluded.

Exclusion criteria at the students’ level were: own incapability to participate in the survey or parents’ refusal to allow participation.

Recruitment start date

15/09/2004

Recruitment end date

15/06/2008

Locations

Countries of recruitment

Austria, Belgium, Germany, Greece, Italy, Spain, Sweden

Trial participating centre

via Solaroli 17
Novara
28100
Italy

Sponsor information

Organisation

Piedmont Centre for Drug Addiction Epidemiology (OED) (Italy)

Sponsor details

via Sabaudia 164
Grugliasco
Torino
10095
Italy
+39 (0)11 40188305
federica.vignataglianti@oed.piemonte.it

Sponsor type

Government

Website

http://www.oed.piemonte.it

Funders

Funder type

Government

Funder name

European Commission. European Public Health Programme 2002 (grant ref: SPC 2002376)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2007 results on anonymous link procedures in http://www.ncbi.nlm.nih.gov/pubmed/16979751
2. 2007 publication on study design and baseline characteristics of the study population in http://www.ncbi.nlm.nih.gov/pubmed/17084887
3. Eudap Final technical report n.1. Unplugged - An effective school-based program for the prevention of substance use among adolescents: http://www.eudap.net/pubblications.html
4. Eudap Final technical report n.2. Final Report 2: Results of the evaluation of a school-based program for the prevention of substance use among adolescents: http://www.eudap.net/pubblications.html
5. 2008 main results in http://www.ncbi.nlm.nih.gov/pubmed/18657569
6. 2009 results on gender-specific effects in http://www.ncbi.nlm.nih.gov/pubmed/19395396
7. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23334820

Publication citations

  1. Results

    Caria MP, Faggiano F, Bellocco R, Galanti MR, , Classroom characteristics and implementation of a substance use prevention curriculum in European countries., Eur J Public Health, 2013, 23, 6, 1088-1093, doi: 10.1093/eurpub/cks191.

  2. Galanti MR, Siliquini R, Cuomo L, Melero JC, Panella M, Faggiano F, , Testing anonymous link procedures for follow-up of adolescents in a school-based trial: the EU-DAP pilot study., Prev Med, 2007, 44, 2, 174-177, doi: 10.1016/j.ypmed.2006.07.019.

  3. Faggiano F, Richardson C, Bohrn K, Galanti MR, , A cluster randomized controlled trial of school-based prevention of tobacco, alcohol and drug use: the EU-Dap design and study population., Prev Med, 2007, 44, 2, 170-173, doi: 10.1016/j.ypmed.2006.09.010.

  4. Faggiano F, Galanti MR, Bohrn K, Burkhart G, Vigna-Taglianti F, Cuomo L, Fabiani L, Panella M, Perez T, Siliquini R, van der Kreeft P, Vassara M, Wiborg G, , The effectiveness of a school-based substance abuse prevention program: EU-Dap cluster randomised controlled trial., Prev Med, 2008, 47, 5, 537-543, doi: 10.1016/j.ypmed.2008.06.018.

  5. Vigna-Taglianti F, Vadrucci S, Faggiano F, Burkhart G, Siliquini R, Galanti MR, , Is universal prevention against youths' substance misuse really universal? Gender-specific effects in the EU-Dap school-based prevention trial., J Epidemiol Community Health, 2009, 63, 9, 722-728, doi: 10.1136/jech.2008.081513.

Additional files

Editorial Notes