|- candidate number||4321|
|- NTR Number||NTR1516|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-nov-2008|
|- Secondary IDs||SW/OOM/AvdK/08.0903 |
|- Public Title||Take it or leave it! Prevention of early substance use in adolescence. |
|- Scientific Title||Take it or leave it! Prevention of early substance use in adolescence. |
|- ACRONYM||The Health School and Drugs (HSD) effectiveness study.|
|- hypothesis||It will be expected that the implementation of the interventions will reduce the substance use by adolescents under the age of 16. |
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||1. Adolescents in the first grade of secondary education. |
2. Schools in which no HSD parental meeting was held in the school year 2008/2009.
3. Schools who did not receive HSD competence training in the past 3 years.
4. Schools in which adolescents are able to attend classes for at least four years.
|- Exclusion criteria||1. Adolescents who do not attend school.|
2. Schools in which a HSD parental meeting was held in the school year 2008/2009.
3. Schools who received HSD competence training in the past 3 years.
4. Schools in which adolescents are not able to attend classes for at least four years.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2008|
|- planned closingdate||1-jun-2012|
|- Target number of participants||4300|
|- Interventions||The objective of the present study is to test the e-learning modules of the HSD program and the integral package of the HSD program. The e-learning modules of HSD concerns three modules: alcohol (4 lessons), tobacco (3 lessons), and cannabis (3 lessons). Students can work through the lessons independently and in their own pace. The lessons work on knowledge, attitude and behavior. The integral package of HSD consists of four major pillars, these are: the e-learning modules, parental participation, a school regulation which addresses substance use, and competence training in signaling and guiding problem users. The parental participation refers to a parental meeting at the school and written information about substance use sent to parents. The third pillar asks schools to incorporate school regulation on substance use among adolescents and employees. The final pillar concerns a protocol on how to deal with problem users. Also, employees receive competence training on this subject. The project starts in the first year of secondary education. Schools will be randomly assigned to one of the following conditions: |
(1) regular curriculum
(2) HSD e-learning modules or
(3) HSD integral package.
|- Primary outcome||Over a course of three years, the effectiveness of HSD is assessed. The interventions are targeted at the reduction of substance use among adolescents. |
Since the program focuses on alcohol use, tobacco use, and cannabis use, we operationalized attainment targets for all three substances.
1. Reduce the percentage of binge drinking (> than five drinks per occasion).
2. Reduce the average weekly number of drinks.
3. Reduce the percentage of adolescents who ever drunk a glass of alcohol.
Reduce the percentage of adolescents who ever smoked a cigarette.
Reduce the percentage of adolescents who ever smoked (a puff of) a joint.
|- Secondary outcome||- Alcohol: |
Reduce the percentage of adolescents who drink on a weekly basis.
Reduce the percentage of adolescents who intend to smoke tobacco in the future.
Reduce the percentage of adolescents who intend to smoke cannabis in the future.
|- Timepoints||January/February 2009|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. Monique Malmberg|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. R.C.M.E. Engels|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen, Trimbos-institute - Netherlands Institute of Mental Health and Addiction, Utrecht University (UU)|
(Source(s) of Monetary or Material Support)
|Dutch Ministry of Health, Welfare and Sport|
|- Brief summary||The Healthy School and Drugs (HSD) project is a widely implemented, school-based prevention program in the Netherlands. HSD targets youngsters in primary and secondary schools and aims to reduce or limit alcohol, tobacco and cannabis use in adolescence. This four-wave longitudinal project will examine the effectiveness of HSD in a randomized clustered trial. The primary goal is to test whether HSD is effective. That is, does the HSD program lead to postponing or diminishing substance use among Dutch adolescents? And what are the actual active components of HSD? Are behavioral changes mainly due to the integral working method of HSD or do youngsters also benefit from one specific component, namely the electronic learning modules? |
The final goal is to investigate how possible behavioral changes come about. Are increased knowledge, better refusal skills, or changed attitudes towards substance (ab)use (partly) accountable for these effects? Answers will be given based on these mediating analyses.
|- Main changes (audit trail)|
|- RECORD||1-nov-2008 - 16-nov-2008|