Well BeingVal3P-LSTNCT07858513

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

A study testing life skills primary prevention in people with Well Being and Drug Addiction, run by Agenzia di Tutela della Salute della Città Metropolitana di Milano at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 8 years and olderHealthy volunteers can take part
Conditions the study is for: Well Being, Drug Addiction, Tobacco Use
What is being tested?: life skills primary prevention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,927 participants
Where: 1 siteItaly
Study dates: 1 Dec 2024to 15 Jun 2030
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

being a student of the classes nominated by the school institutions involved
consent from parents

Who cannot join

not being a student of the classes nominated by the school institutions involved
consent denial from parents

Trial locations and contacts

1 site in 1 country.

Italy1 site

Regione Lombardia
Milan

Other trials in Italy

About this study

Official title: Evaluation of Effectiveness of the LifeSkills Training Program - Lombardia Region - for Primary Shool Students (Val3P-LST)

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.

Read the detailed description

The primary objective of the study is to evaluate the effectiveness of the LST Primary Lombardia program applied to primary school in relation to the prevention of risky behaviors such as the initiation of tobacco and alcohol consumption, measured in the long term at the time of attendance in lower secondary school.

In the short term, however, well-being will be measured as the primary outcome.

The secondary objectives to be measured in the short term are:

other health outcomes such as violence/bullying;
the development of the following life skills: decision making, stress management, self-control, communication skills, assertiveness, social skills, critical thinking/media resistance;
changes in health literacy;
normative beliefs and attitudes in relation to tobacco and alcohol, as well as other risk factors relating to nutrition and physical activity;
the school climate.

The study also plans to evaluate:

the context of the program implementation;
the quality of implementation by schools;
sustainability.

Conditions: Well Being, Drug Addiction, Tobacco Use, Alcohol Abuse, Life Skills, Violence
Being tested: life skills primary prevention
Keywords: school based intervention, primary prevention, life skills, tobacco, drug, alcohol, violence, bullying, well being, experimental study, RCT, health literacy, Italy
Medical subject headings: Substance-Related Disorders, Tobacco Use, Alcoholism, Bullying

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

life skills primary preventionBehavioural
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 groups in NCT07858513
Study group	Role	What they receive
LST	Experimental	The LST Lombardy Primary Program was designed to be used with students in the third, fourth and fifth grades of primary school. The topics covered during the first year are taken up again during the following two school years (fourth and fifth year of primary school), with a view to strengthening skills and competences also recognized as predisposing factors for learning. The Program is also designed in a vertical perspective, considering the possibility that students continue to work with LifeSkills Training even during lower secondary school. Each of the three levels is made up of 8 teaching units, structured into lessons of 3 hours each, to be carried out in class on a preferably weekly basis for an indicative total duration of 24 hours. The path involves the involvement of families in parallel with the carrying out of the work units in the classroom, in order to reinforce the coherence of the messages transmitted between School and Family. Receives: Behavioral: life skills primary prevention
Usual curriculum	No intervention	Classes assigned to the control gruop would not implement the LST program and istead will follow the usual curriculum.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

life skills
different such as decision making, stress management, self-control, communication skills, assertiveness, social skills, critical thinking/media resistance, normative beliefs are measured through the use of ad hoc scales
Measured: From enrollment to the end of first school year, the end of the second and the end of the third year
health literacy
children understanding and decision making on health issues is measured through the use of ad hoc scales
Measured: From enrollment to the end of first school year, the end of the second and the end of the third year
normative beliefs and attitudes on tobacco and alcohol
normative beliefs and attitudes on tobacco and alcohol wil be measured through ad hoc items
Measured: At the end of the third school year
bullying and violence
children competences to deal and recognize violence related situations are measured through ad hoc scales
Measured: At the end of third school year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202415 Jun 2030

First posted5 Oct 2026
Study start1 Dec 2024
Primary completion15 Jun 2027 (estimated)
Study completion15 Jun 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Well BeingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Cluster randomized controlled trial
Masking: None (open label)
Enrolment: 3,927 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07858513
Sponsor's protocol ID: Prot 0454963
Acronym: Val3P-LST
Status last verified: Sep 2026
First submitted: 29 Sep 2026
Last updated: 5 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: we will do it with a time delay (eg. 10 years)

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Effectiveness of the LifeSkills Training Program - Lombardia Region - for Primary Shool Students (Val3P-LST)
ClinicalTrials.gov ID: NCT07858513
Acronym / sponsor ID: Val3P-LST / Prot 0454963
Conditions: Well Being, Drug Addiction, Tobacco Use, Alcohol Abuse, Life Skills, Violence
Keywords: school based intervention, primary prevention, life skills, tobacco, drug, alcohol, violence, bullying
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 3,927 participants (estimated)
Lead sponsor: Agenzia di Tutela della Salute della Città Metropolitana di MilanoOther government
Collaborators: Università degli Studi del Piemonte Orientale Amedeo Avogadro, University of Milano Bicocca
Study start: 1 Dec 2024 (actual)
Primary completion: 15 Jun 2027 (estimated)
Study completion: 15 Jun 2030 (estimated)
First posted: 5 Oct 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

In the short term, however, well-being will be measured as the primary outcome.

The secondary objectives to be measured in the short term are:

other health outcomes such as violence/bullying;
the development of the following life skills: decision making, stress management, self-control, communication skills, assertiveness, social skills, critical thinking/media resistance;
changes in health literacy;
normative beliefs and attitudes in relation to tobacco and alcohol, as well as other risk factors relating to nutrition and physical activity;
the school climate.

The study also plans to evaluate:

the context of the program implementation;
the quality of implementation by schools;
sustainability.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Cluster randomized controlled trial

Arm	Type	Receives
LST	Experimental	Behavioral: life skills primary preventionThe LST Lombardy Primary Program was designed to be used with students in the third, fourth and fifth grades of primary school. The topics covered during the first year are taken up again during the following two school years (fourth and fifth year of primary school), with a view to strengthening skills and competences also recognized as predisposing factors for learning. The Program is also designed in a vertical perspective, considering the possibility that students continue to work with LifeSkills Training even during lower secondary school. Each of the three levels is made up of 8 teaching units, structured into lessons of 3 hours each, to be carried out in class on a preferably weekly basis for an indicative total duration of 24 hours. The path involves the involvement of families in parallel with the carrying out of the work units in the classroom, in order to reinforce the coherence of the messages transmitted between School and Family.
Usual curriculum	No intervention	–Classes assigned to the control gruop would not implement the LST program and istead will follow the usual curriculum.

Who may qualify

Ages: 8 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

being a student of the classes nominated by the school institutions involved
consent from parents

Key exclusion criteria (2 listed)

not being a student of the classes nominated by the school institutions involved
consent denial from parents

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
life skills primary preventionLifeSkills 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.).	Behavioural	LST

Primary outcome

well being
Time frame: 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

4 secondary outcomes

life skills
Time frame: From enrollment to the end of first school year, the end of the second and the end of the third year
health literacy
Time frame: From enrollment to the end of first school year, the end of the second and the end of the third year
normative beliefs and attitudes on tobacco and alcohol
Time frame: At the end of the third school year
bullying and violence
Time frame: At the end of third school year

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
Individual participant dataSharing planned: Undecided. we will do it with a time delay (eg. 10 years)

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing life skills primary prevention in people with Well Being and Drug Addiction, run by Agenzia di Tutela della Salute della Città Metropolitana di Milano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

well being (time frame: From enrollment to the end of first school year, the end of the second and the end of the third year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07858513.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.