search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Effectiveness of Fresh Start: a pilot study of a school-based program to retain a negative attitude towards substance use in high school freshman.


- candidate number24313
- NTR NumberNTR5925
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-mei-2016
- Secondary IDsTET201508_02. METC
- Public TitleEffectiveness of Fresh Start: a pilot study of a school-based program to retain a negative attitude towards substance use in high school freshman.
- Scientific TitleEffectiveness of Fresh Start: a pilot study of a school-based program to retain a negative attitude towards substance use in high school freshman.
- ACRONYMFS
- hypothesis1. High school Freshman develop less positive attitudes towards substance use after participation in Fresh Start than high school freshman in the waitlist control condition.
2. Fresh Start is more effective when it is implemented at the beginning of the first year of secondary school (experimentel group) than when it is implemented at the end of the year (waitlist control condition).
- Healt Condition(s) or Problem(s) studiedSubstance abuse
- Inclusion criteria1. All secondary schools with multiple first year classes were eligible for participation in the study.
2. All participating teachers were required to participate in a three hour training session before they were allowed to teach the curriculum.
3. All high school freshman of participating schools were eligible for participation in the study.
4. Passive informed consent from parents.
- Exclusion criteriaParticipants not meeting the aforementioned criteria.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate1-sep-2016
- Target number of participants1280
- InterventionsIn elementary school, substance use is rare, and the attitude towards substance use is predominantly negative. In early adolescence, children experience several important biological, cognitive and psychosocial changes. In addition, children experience profound environmental changes as they make the transition to secondary school. The transition from childhood and elementary school to adolescence and secondary school is linked to shifting attitudes towards substances from negative to more positive, resulting in a increased vulnerability for substance use. Fresh Start is a preventive intervention that consists of a curriculum of 4 lessons, a parent conference and a brochure for parents. The ultimate goal of Fresh Start is to retain a negative attitude towards substance use. Therefore the lessons propagate the social norm that substance use is not normal in early adolescente (most early adolescents do not use substances) and is not acceptable. The lessons provide information on the risks of substance use, and teach the students to make healthy choices. In addition, the lessons adress the transition to secondary school. The parents are provided with information on early adolescence, and the importance of rules regarding substance use.
- Primary outcomeAttitude towards substance use (attitude towards smoking;
attitude towards alcohol use; attitude towards cannabis use);
The primary outcomes are measured at baseline, posttest 1, and posttest 2
- Secondary outcome1. The intention to use substance in the future (smoking, alcohol use, and cannabis use).
2. Frequency of substance use (smoking, alcohol use, and cannabis use).
3. Experienced social norms (smoking, alcohol use, and cannabis use).
4. Risk perception (smoking, alcohol use, and cannabis use).
5. Refusal self-efficacy (smoking, alcohol use, and cannabis use).
Alle secondary outcomes are measured at baseline, posttest 1, and posttest 2
- Timepointsbaseline (Fall 2015)
posttest 1 (February - March 2016)
posttest 2 (Summer 2016)
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMsc J. Lammers
- CONTACT for SCIENTIFIC QUERIESDr. S. Onrust
- Sponsor/Initiator Trimbos-institute - Netherlands Institute of Mental Health and Addiction
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Health, Welfare and Sports (VWS)
- Publications
- Brief summaryIn elementary school, substance use is rare, and the attitude towards substance use is predominantly negative. In early adolescence, children experience several important biological, cognitive and psychosocial changes. In addition, children experience profound environmental changes as they make the transition to secondary school. The transition from childhood and elementary school to adolescence and secondary school is linked to shifting attitudes towards substances from negative to more positive, resulting in a increased vulnerability for substance use. Fresh Start is a preventive intervention that aims to retain a negative attitude towards substance use in high school freshman. We conduct a pilot study to test whether this newly developed intervention succeeds to do so. In addition we test the assumption that the intervention is most succesful early in the school year, directly after students made the transition to secondary school. Classes with first year students are randomized to either the experimental condition (receiving Fresh Start at the beginning of the school year) or the waitlist control condition (receiving Fresh Start at the end of the school year).
- Main changes (audit trail)
- RECORD3-mei-2016 - 8-aug-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl