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Randomized Controlled Trial
. 2019 Jun 13;19(1):750.
doi: 10.1186/s12889-019-7090-9.

Effectiveness evaluation of the school-based drug prevention program #Tamojunto2.0: protocol of a cluster randomized controlled trial

Zila M Sanchez  1 , Juliana Y Valente  2 , Ana Paula Dias Pereira  2 , Hugo Cogo-Moreira  3 , Márcia H S Melo  4 , Sheila C Caetano  3 , Jair J Mari  3
Affiliations
Randomized Controlled Trial

Effectiveness evaluation of the school-based drug prevention program #Tamojunto2.0: protocol of a cluster randomized controlled trial

Zila M Sanchez et al. BMC Public Health. .

Abstract

Background: The European school-based drug addiction prevention program Unplugged was adapted to the Brazilian context by the Ministry of Health and renamed #Tamojunto. Its first implementations, in the form of a public policy in Brazil, showed contradictory and different effects from those observed in Europe. Adaptations were made to #Tamojunto in 2018 to reintroduce the essential content of the original program.

Methods: A parallel, two-arm, randomized controlled trial (RCT) will be conducted to evaluate the effectiveness of the new version of the school-based government program #Tamojunto2.0 for the prevention of drug use among 8th grade middle school students from 70 public schools in three Brazilian cities, totaling approximately 6.300 participating students distributed in 210 classes. For intervention, the experimental group will receive the 12 lessons of the #Tamojunto2.0 program under the supervision of a Brazilian Ministry of Health team. The control group will not receive any intervention. Information will be collected from the students at three time points: preintervention and 9 and 18 months postintervention. Multilevel analyses will be performed using the Gllamm Stata program to assess simultaneous differences in prevalence, in time and among groups for the outcomes of interest. Structural equation modeling will be used to evaluate the effectiveness of the intervention in changing the behavioral patterns of the adolescents through latent transition analysis. The effect of the mediators involved in the program effectiveness outcomes will also be analyzed. The program doses applied in all classes of the intervention group will be collected using a form completed by the teacher at the end of each lesson, indicating the activities taught and not taught in each lesson.

Discussion: This study will show whether the #Tamojunto2.0 program can be expanded as a public policy for all schools with the aim of preventing drug use among Brazilian students.

Trial registration: Brazilian Clinical Trials Registry (RBR-8cnkwq) under the name "Avaliação do Efeito do Programa de Prevenção Escolar ao Uso de Drogas #Tamojunto2.0, Versão 2018", on August 30th, 2018 ( http://www.ensaiosclinicos.gov.br/rg/RBR-8cnkwq/ ).

Keywords: Drug use; Prevention programs; Protocol study; Randomized controlled trial.

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Conflict of interest statement

Zila M Sanchez is a member of the editorial board of this journal. The other authors have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of the general design of the effectiveness evaluation of Tamojunto 2.0
Fig. 2
Fig. 2
Mediation model for the outcomes of students participating in the evaluation of the #Tamojunto2.0. program; Three mediation models will be generated using the outcome variables of drug use in the past year and in the past month and incidence of drug use
See this image and copyright information in PMC

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