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

Primary Purpose

Substance Use, Behavior, Addictive, Smoking Behaviors

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
"It´s Up To You" program
Sponsored by
Instituto Europeo de Estudios en Prevención
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto Europeo de Estudios en Prevención

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

"It´s Up To You" program

Control

Arm Description

Participants will receive the prevention program "It´s Up To You" during the academic year in school hours.

The control group will receive the usual teaching activities regarding substance use prevention.

Outcomes

Primary Outcome Measures

Substance use: Alcohol
Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs
Substance use: Tobacco
Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs
Substance use: Cannabis
Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs

Secondary Outcome Measures

Attitudes toward substance use
Attitudes towards drug use Scale
Intention to use alcohol
Intention to drug use in the next month Scale
Intention to use tobacco
Intention to drug use in the next month Scale
Intention to use cannabis
Intention to drug use in the next month Scale
Academic performance
Assessed as having repeated grades
Emotion regulation
Cognitive Emotion Regulation Questionnaire

Full Information

First Posted
June 20, 2023
Last Updated
July 14, 2023
Sponsor
Instituto Europeo de Estudios en Prevención
Collaborators
University of Santiago de Compostela, University of Oviedo, University of the Balearic Islands
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1. Study Identification

Unique Protocol Identification Number
NCT05950074
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Europeo de Estudios en Prevención
Collaborators
University of Santiago de Compostela, University of Oviedo, University of the Balearic Islands

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Behavior, Addictive, Smoking Behaviors, Alcohol Drinking, Illicit Drug Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"It´s Up To You" program
Arm Type
Experimental
Arm Description
Participants will receive the prevention program "It´s Up To You" during the academic year in school hours.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will receive the usual teaching activities regarding substance use prevention.
Intervention Type
Behavioral
Intervention Name(s)
"It´s Up To You" program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Substance use: Alcohol
Description
Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs
Time Frame
Past 30-day period
Title
Substance use: Tobacco
Description
Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs
Time Frame
Past 30-day period
Title
Substance use: Cannabis
Description
Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs
Time Frame
Past 30-day period
Secondary Outcome Measure Information:
Title
Attitudes toward substance use
Description
Attitudes towards drug use Scale
Time Frame
Past 30-day period
Title
Intention to use alcohol
Description
Intention to drug use in the next month Scale
Time Frame
Next 30-day period
Title
Intention to use tobacco
Description
Intention to drug use in the next month Scale
Time Frame
Next 30-day period
Title
Intention to use cannabis
Description
Intention to drug use in the next month Scale
Time Frame
Next 30-day period
Title
Academic performance
Description
Assessed as having repeated grades
Time Frame
Past 12-months period
Title
Emotion regulation
Description
Cognitive Emotion Regulation Questionnaire
Time Frame
Past 30-day period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Montserrat Juan, PhD
Phone
+34 871002385
Email
mjuan@irefrea.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mariàngels Duch, MA
Phone
+34 871002384
Email
mduch@irefrea.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Montserrat Juan, PhD
Organizational Affiliation
Instituto Europeo de Estudios en Prevención
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Europeo de Estudios en Prevención
City
Palma De Mallorca
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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