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Active, not recruiting Not applicable

Evaluation of Effectiveness of the LifeSkills Training - Lombardia - Primary Shool Program ( Val3P-LST )

NCT07858513 · tracked via the Priya Life Science Italy tracker
Sponsor
Agenzia di Tutela della Salute della Città Metropolitana di Milano
Phase
Not applicable
Started
2024-12-01
Last updated
2026-10-05

Condition(s) studied

Well BeingDrug AddictionTobacco UseAlcohol AbuseLife SkillsViolenceBullyingHealth Literacy

Investigational drug(s) / intervention(s)

life skills primary prevention

life skills primary prevention: LifeSkills Training (LST) is an American educational program for the prevention and health promotion of the school population. The program has been shown to be able to reduce, 6 years after the start of the program, the risk of use of alcohol, tobacco, drugs (Botvin et al., 1995) and violent behavior (Botvin, Griffin and Nichols 2006) through the increase of personal and social skills. This aims to increase subjects' ability to manage daily challenges and foster a greater sense of personal control. To this end, it tries to intervene on the various factors that favor the initiation of substance use and other risky behaviours, whether they relate to external influences (the environment, the media, peers, etc.) or to internal psychological factors (social anxiety, low self-esteem, propensity to seek strong emotions, etc.).

Study 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

Sex
ALL
Min age
8 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • well being — From enrollment to the end of first school year, the end of the second and the end of the third year
    different dimensions of well-being (eg. school well-being, emotional state, positive outlook) are measured through the use of ad hoc scales

Trial sites (1)

FacilityCityRegionStatus
Regione Lombardia Milan Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07858513 on ClinicalTrials.gov ↗ ← All trials in Italy