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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05950074
Recruitment Status : Active, not recruiting
First Posted : July 18, 2023
Last Update Posted : March 8, 2024
Sponsor:
Collaborators:
University of Santiago de Compostela
University of Oviedo
University of the Balearic Islands
Information provided by (Responsible Party):
Instituto Europeo de Estudios en Prevención

Study Description
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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.

Condition or disease Intervention/treatment Phase
Substance Use Behavior, Addictive Smoking Behaviors Alcohol Drinking Illicit Drug Use Behavioral: "It´s Up To You" program Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Update and Digitalization of a Universal School-based Prevention Intervention for Drug Initiation and Use: the "It´s Up To You" Program
Actual Study Start Date : October 1, 2023
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Substance use: Alcohol [ Time Frame: Past 30-day period ]
    Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs

  2. Substance use: Tobacco [ Time Frame: Past 30-day period ]
    Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs

  3. Substance use: Cannabis [ Time Frame: Past 30-day period ]
    Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs


Secondary Outcome Measures :
  1. Attitudes toward substance use [ Time Frame: Past 30-day period ]
    Attitudes towards drug use Scale

  2. Intention to use alcohol [ Time Frame: Next 30-day period ]
    Intention to drug use in the next month Scale

  3. Intention to use tobacco [ Time Frame: Next 30-day period ]
    Intention to drug use in the next month Scale

  4. Intention to use cannabis [ Time Frame: Next 30-day period ]
    Intention to drug use in the next month Scale

  5. Academic performance [ Time Frame: Past 12-months period ]
    Assessed as having repeated grades

  6. Emotion regulation [ Time Frame: Past 30-day period ]
    Cognitive Emotion Regulation Questionnaire


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05950074


Locations
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Spain
Instituto Europeo de Estudios en Prevención
Palma De Mallorca, Spain
Sponsors and Collaborators
Instituto Europeo de Estudios en Prevención
University of Santiago de Compostela
University of Oviedo
University of the Balearic Islands
Investigators
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Principal Investigator: Montserrat Juan, PhD Instituto Europeo de Estudios en Prevención
More Information
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Responsible Party: Instituto Europeo de Estudios en Prevención
ClinicalTrials.gov Identifier: NCT05950074    
Other Study ID Numbers: 2021F055 Tu decides
First Posted: July 18, 2023    Key Record Dates
Last Update Posted: March 8, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Alcohol Drinking
Behavior, Addictive
Chemically-Induced Disorders
 Mental Disorders
Drinking Behavior
Compulsive Behavior
Impulsive Behavior