It´s Up To You: Update and Digitalization of a Universal School-based Prevention Intervention for Drug Initiation and Use

Study Overview
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Brief Summary
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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
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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.

Official Title
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Update and Digitalization of a Universal School-based Prevention Intervention for Drug Initiation and Use: the It´s Up To You Program

Conditions
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Substance Use, Behavior, Addictive, Smoking Behaviors, Alcohol Drinking, Illicit Drug Use

Intervention / Treatment
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* Behavioral: It´s Up To You program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Schools having secondary education Schools located in Spain. Schools willing to participate under the conditions of the study Exclusion Criteria: Schools applying the original It´s Up To You prevention program

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: It´s Up To You program<br>Participants will receive the prevention program It´s Up To You during the academic year in school hours. | Behavioral: It´s Up To You program<br>* 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.<br>|
| No Intervention: Control<br>The control group will receive the usual teaching activities regarding substance use prevention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance use: Alcohol | Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs | 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 | 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 | Past 30-day period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitudes toward substance use | Attitudes towards drug use Scale | Past 30-day period | 
| Intention to use alcohol | Intention to drug use in the next month Scale | Next 30-day period | 
| Intention to use tobacco | Intention to drug use in the next month Scale | Next 30-day period | 
| Intention to use cannabis | Intention to drug use in the next month Scale | Next 30-day period | 
| Academic performance | Assessed as having repeated grades | Past 12-months period | 
| Emotion regulation | Cognitive Emotion Regulation Questionnaire | Past 30-day period |