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

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05950074
• Other study ID #: 2021F055 Tu decides
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2024
• Source: Instituto Europeo de Estudios en Prevención
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: July 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Behavior, Addictive
• Illicit Drug Use
• Smoking Behaviors
• Substance Use
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
Spain	Instituto Europeo de Estudios en Prevención	Palma De Mallorca

Sponsors (4)

Lead Sponsor	Collaborator
Instituto Europeo de Estudios en Prevención	University of Oviedo, University of Santiago de Compostela, University of the Balearic Islands

Country where clinical trial is conducted

Spain, 

Outcome

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