Substance UseNCT05950074
It´s Up To You: Update and Digitalization of a Universal School-based Prevention Intervention for Drug Initiation and Use
A study testing "It´s Up To You" program in people with Substance Use and Behavior, Addictive, run by Instituto Europeo de Estudios en Prevención at 1 site in Spain.
Trial summary
This non-randomized cluster-controlled trial examines the effectiveness of the digitalized and updated version of the It´s Up To You - program, a universal school-based prevention intervention for drug initiation and use targeting youth aged between 12 and 17 years. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Behavior, Addictive, Smoking Behaviors
- What is being tested?
- "It´s Up To You" program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schools having secondary education
- Schools located in Spain.
- Schools willing to participate under the conditions of the study
Who cannot join
- Schools applying the original "It´s Up To You" prevention program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Update and Digitalization of a Universal School-based Prevention Intervention for Drug Initiation and Use: the "It´s Up To You" Program
This non-randomized cluster-controlled trial examines the effectiveness of the digitalized and updated version of the It´s Up To You - program, a universal school-based prevention intervention for drug initiation and use targeting youth aged between 12 and 17 years.
Read the detailed description
The goal of this non-randomized cluster-controlled trial targeting youth aged between 12 and 17 years is to examine whether the updated and digitalized version of the preventive intervention named "It´s Up To You" program is effective in preventing drug use initiation and reducing drug use.
Participants in the experimental group will receive 6 sessions conducted by trained teachers. Each session will target a program module about the following topics: (1) What about drugs? (2) A way to start (3) Ana has fun (4) What do you connect to (about the use of the internet and social networks)? (5) Two versions of the same story, and (6) How do my parents come in?
Researchers will compare the experimental group receiving the "It´s Up To You" program to a control group receiving the usual teaching activities regarding substance use prevention. The main goal is to see if participants in the experimental group report lower substance (alcohol, tobacco, and cannabis) use and initiation after the intervention and at a 3-month follow-up related to the control group.
- Being tested
- "It´s Up To You" program
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive, Smoking, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"It´s Up To You" programBehavioural
The main goal of this program is to prevent substance use and engagement in addictive behaviors through enabling teenagers to make informed and responsible decisions. It seeks to support students in the anticipation of realistic choice situations and problems typically affecting this age group. It is based on social influences, considering the peer group influences (peer pressure) and the affective and cognitive factors that intervene at the time of decision-making and problem-resolution. This program is intended to be delivered by trained teachers in six sessions through six different modules.
| Study group | Role | What they receive |
|---|---|---|
| "It´s Up To You" program | Experimental | Participants will receive the prevention program "It´s Up To You" during the academic year in school hours. Receives: Behavioral: "It´s Up To You" program |
| Control | No intervention | The control group will receive the usual teaching activities regarding substance use prevention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use: Alcohol
Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs
Measured: Past 30-day period
Substance use: Tobacco
Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs
Measured: Past 30-day period
Substance use: Cannabis
Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs
Measured: Past 30-day period
Secondary outcomes (6)
Attitudes toward substance use
Attitudes towards drug use Scale
Measured: Past 30-day period
Intention to use alcohol
Intention to drug use in the next month Scale
Measured: Next 30-day period
Intention to use tobacco
Intention to drug use in the next month Scale
Measured: Next 30-day period
Intention to use cannabis
Intention to drug use in the next month Scale
Measured: Next 30-day period
Academic performance
Assessed as having repeated grades
Measured: Past 12-months period
Emotion regulation
Cognitive Emotion Regulation Questionnaire
Measured: Past 30-day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Oct 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Europeo de Estudios en Prevención
- Sponsor type
- University, hospital or other
- Collaborators
- University of Santiago de Compostela, University of Oviedo, University of the Balearic Islands
- Responsible party
- Sponsor
- Investigators
- Montserrat Juan, PhD, Principal investigator, Instituto Europeo de Estudios en Prevención
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950074
- Sponsor's protocol ID
- 2021F055 Tu decides
- Status last verified
- Mar 2024
- First submitted
- 20 Jun 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Castano Y, Gervilla E, Martinez-Vispo C, Juan M, Garcia-Pazo P, Al-Halabi S, Becona E, Calafat A. Effectiveness of a School-Based Drug Prevention Program: Tu Decides 2.0. J Prev (2022). 2026 Feb;47(1):191-207. doi: 10.1007/s10935-025-00883-6. Epub 2025 Nov 17.
PubMed 41247593
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Update and Digitalization of a Universal School-based Prevention Intervention for Drug Initiation and Use: the "It´s Up To You" Program
- ClinicalTrials.gov ID
- NCT05950074
- Acronym / sponsor ID
- 2021F055 Tu decides
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Instituto Europeo de Estudios en PrevenciónUniversity, hospital or other
- Collaborators
- University of Santiago de Compostela, University of Oviedo, University of the Balearic Islands
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 18 Jul 2023 (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.
This non-randomized cluster-controlled trial examines the effectiveness of the digitalized and updated version of the It´s Up To You - program, a universal school-based prevention intervention for drug initiation and use targeting youth aged between 12 and 17 years.
Detailed description
The goal of this non-randomized cluster-controlled trial targeting youth aged between 12 and 17 years is to examine whether the updated and digitalized version of the preventive intervention named "It´s Up To You" program is effective in preventing drug use initiation and reducing drug use.
Participants in the experimental group will receive 6 sessions conducted by trained teachers. Each session will target a program module about the following topics: (1) What about drugs? (2) A way to start (3) Ana has fun (4) What do you connect to (about the use of the internet and social networks)? (5) Two versions of the same story, and (6) How do my parents come in?
Researchers will compare the experimental group receiving the "It´s Up To You" program to a control group receiving the usual teaching activities regarding substance use prevention. The main goal is to see if participants in the experimental group report lower substance (alcohol, tobacco, and cannabis) use and initiation after the intervention and at a 3-month follow-up related to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "It´s Up To You" program | Experimental | Behavioral: "It´s Up To You" programParticipants will receive the prevention program "It´s Up To You" during the academic year in school hours. |
| Control | No intervention | –The control group will receive the usual teaching activities regarding substance use prevention. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Schools having secondary education
- Schools located in Spain.
- Schools willing to participate under the conditions of the study
Key exclusion criteria (1 listed)
- Schools applying the original "It´s Up To You" prevention program
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 |
|---|---|---|
| "It´s Up To You" programThe main goal of this program is to prevent substance use and engagement in addictive behaviors through enabling teenagers to make informed and responsible decisions. It seeks to support students in the anticipation of realistic choice situations and problems typically affecting this age group. It is based on social influences, considering the peer group influences (peer pressure) and the affective and cognitive factors that intervene at the time of decision-making and problem-resolution. This program is intended to be delivered by trained teachers in six sessions through six different modules. | Behavioural | "It´s Up To You" program |
Primary outcome
Substance use: Alcohol
Time frame: Past 30-day period
Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs
Substance use: Tobacco
Time frame: Past 30-day period
Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs
Substance use: Cannabis
Time frame: Past 30-day period
Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs
6 secondary outcomes
Attitudes toward substance use
Time frame: Past 30-day period
Intention to use alcohol
Time frame: Next 30-day period
Intention to use tobacco
Time frame: Next 30-day period
Intention to use cannabis
Time frame: Next 30-day period
Academic performance
Time frame: Past 12-months period
Emotion regulation
Time frame: Past 30-day period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Derived from this study: PubMed 41247593Castano Y, Gervilla E, Martinez-Vispo C, Juan M, Garcia-Pazo P, Al-Halabi S, Becona E, Calafat A. Effectiveness of a School-Based Drug Prevention Program: Tu Decides 2.0. J Prev (2022). 2026 Feb;47(1):191-207. doi: 10.1007/s10935-025-00883-6. Epub 2025 Nov 17.
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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.
Montserrat Juan, PhD principal investigator
Instituto Europeo de Estudios en Prevención
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "It´s Up To You" program in people with Substance Use and Behavior, Addictive, run by Instituto Europeo de Estudios en Prevención at 1 site in Spain.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. 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 Spain. 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?
Results are not available in the source record.
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?
Substance use: Alcohol (time frame: Past 30-day period). The study lists 3 primary outcomes in all. 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 NCT05950074, which also lists 1 linked publication.
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 8 Mar 2024.