Clinical trial NCT05950074: It´s Up To You: Update and Digitalization of a Universal School-based Prevention Intervention for Drug Initiation and Use
Official title: Update and Digitalization of a Universal School-based Prevention Intervention for Drug Initiation and Use: the "It´s Up To You" Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Use
Behavior, Addictive
Smoking Behaviors
Alcohol Drinking
Illicit Drug Use
Lead sponsor: Instituto Europeo de Estudios en Prevención
Sponsor class: OTHER
Collaborators: name: University of Santiago de Compostela
name: University of Oviedo
name: University of the Balearic Islands
First posted: 2023-07-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Substance use: Alcohol
timeFrame: Past 30-day period
measure: Substance use: Tobacco
timeFrame: Past 30-day period
measure: Substance use: Cannabis
timeFrame: Past 30-day period
Secondary outcomes:
measure: Attitudes toward substance use
timeFrame: Past 30-day period
measure: Intention to use alcohol
timeFrame: Next 30-day period
measure: Intention to use tobacco
timeFrame: Next 30-day period
measure: Intention to use cannabis
timeFrame: Next 30-day period
measure: Academic performance
timeFrame: Past 12-months period
measure: Emotion regulation
timeFrame: Past 30-day period
Other outcomes:
Locations:
city: Palma De Mallorca
country: Spain
facility: Instituto Europeo de Estudios en Prevención
Study officials:
affiliation: Instituto Europeo de Estudios en Prevención
name: Montserrat Juan, PhD
role: PRINCIPAL_INVESTIGATOR
References: