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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alcohol Drinking; Behavior, Addictive; Substance Use; Smoking Behaviors; Illicit Drug Use
• Intervention / Treatment: Behavioral: "It´s Up To You" program

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 Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Palma De Mallorca, Spain
    • Instituto Europeo de Estudios en Prevención

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "It´s Up To You" program; 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; 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.
No Intervention: Control; The control group will receive the usual teaching activities regarding substance use prevention.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto Europeo de Estudios en Prevención
• Collaborators: University of the Balearic Islands; University of Oviedo; University of Santiago de Compostela
• Investigators: Principal Investigator: Montserrat Juan, PhD, Instituto Europeo de Estudios en Prevención

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Compulsive Behavior; Impulsive Behavior; Substance-Related Disorders; Alcohol Drinking; Behavior, Addictive
• Other Study ID Numbers: 2021F055 Tu decides

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No