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Active Not Recruiting
NCT07858513
Evaluation of Effectiveness of the LifeSkills Training - Lombardia - Primary Shool Program ( Val3P-LST )
Conditions: Well Being, Drug Addiction, Tobacco Use, Alcohol Abuse, Life Skills, Violence, Bullying, Health Literacy
Sex: All
Ages: 8 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 3927
Sponsor: Agenzia di Tutela della Salute della Città Metropolitana di Milano
Location: Regione Lombardia Milan
Summary
Life Skills Training is a school-based prevention program aiming at promoting wellbeing and at preventig use of substances. It has a version for middle school and another for primary school students. The LST-Primary has been evaluated evaluated in US with partially positive results. Regione Lombardia decided to translate and adapt the LST-Primary program for the Italian population. In a first time, involving the US developers, the program has been translated and adapted to Italian students. The present study is aimed at evaluating the effectiveness of the program adopting an experimental design and a random allocation of the condition.
Eligibility Criteria
Schools institutions which have both primary and middle schools based in Lombardy and composed of at least 2 primary schools, with at least 1 middle school, are eligible for participation. Schools institutions are requested to nominate one or more pairs of primary schools for the study (but no more than four). Each school nominates the same number of classes (but no more than four).
The study design is a cluster randomized controlled trial, with random assignment of the intervention, to parallel groups. The intervention will be conducted at class level, the randomization will take place at school level.
Inclusion Criteria:
* being a student of the classes nominated by the school institutions involved
* consent from parents
Exclusion Criteria:
* not being a student of the classes nominated by the school institutions involved
* consent denial from parents
Source: ClinicalTrials.gov (NCT07858513). StuddyBuddy aggregates publicly available trial information.