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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
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
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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.
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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.
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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.
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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.
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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.