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Evaluation of "The Healty School and Drugs" (= "De Gezonde School en Genotmiddelen") for elementary schools.


- candidate number9443
- NTR NumberNTR2904
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mei-2011
- Secondary IDs24000417 / ECG30062011 Radboud University Nijmegen / METC
- Public TitleEvaluation of "The Healty School and Drugs" (= "De Gezonde School en Genotmiddelen") for elementary schools.
- Scientific TitleEvaluation of "The Healty School and Drugs" (= "De Gezonde School en Genotmiddelen") for elementary schools.
- ACRONYM
- hypothesisChildren in the intervention conditions will be more likely to have negative attitudes and norms towards smoking and alcohol than children in the control condition.
- Healt Condition(s) or Problem(s) studiedSmoking, Alcohol
- Inclusion criteriaAll children in the last two classes of elementary school (= groep 7 en 8) are eligible for participation.
- Exclusion criteriaSchools which already participated in 2010-2011 with "The Healthy School and Drugs".
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2011
- planned closingdate1-jun-2012
- Target number of participants300
- InterventionsThere are two intervention conditions and a control condition.The first intervention includes the use of the two textbooks “Smoking" and " Alcohol". At the end of the intervention, an information evening will be organized by the local Municipal Health Service to involve the parents. For the teachers a manual is available. In the second intervention the students will use the textbook “Alcohol & smoking, another story". Also an evening for parents will be organized. At this evening the children will present what they have learned during the intervention and they will show what they have designed as part of different assignments described in the manuals. Also for this intervention a manual is available for the teachers. The control condition is characterized by business as usual and does not receive an intervention.
- Primary outcomeThe program is based on the ASE model, which is often used for predicting and explaining health behavior, in this case substance use (De Vries et al., 1988). In this study, the focus is on intention to use.
- Secondary outcomeIntention is determined by:
1. The attitude towards substance use;
2. The social influence of friends and family to use or not to use substances;
3. The self-efficacy that is experienced in tempting situations (De Vries et al., 2005).
- TimepointsPlan:
T1: November 2011;
T2: April 2012.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Rebecca Leeuw, de
- CONTACT for SCIENTIFIC QUERIES Rebecca Leeuw, de
- Sponsor/Initiator Radboud University Medical Center Nijmegen, Trimbos-institute - Netherlands Institute of Mental Health and Addiction
- Funding
(Source(s) of Monetary or Material Support)
Trimbos Institute - Netherlands Institute of Mental Health and Addiction, Ministry of Health, Welfare and Sports
- PublicationsN/A
- Brief summaryTe aim of the study is: To assess the effectiveness of the universal program “The Healthy School and Drugs” (= “De Gezonde School en Genotmiddelen”) for elementary schools by conducting a clustered pilot randomized controlled trial including Dutch elementary schools. The outcome will not be direct effects on substance use behavior, but effects on the determinants underlying this behavior: Attitude, social influence, self-efficacy and the intention to use in the future.
- Main changes (audit trail)
- RECORD17-mei-2011 - 18-okt-2011


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