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

• Sponsor: Instituto Europeo de Estudios en Prevención (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05950074
• Collaborator: University of Santiago de Compostela (Other), University of Oviedo (Other), University of the Balearic Islands (Other)
• Enrollment: 1,000
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 100.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Use; Behavior, Addictive; Smoking Behaviors; Alcohol Drinking; Illicit Drug Use	Behavioral: "It´s Up To You" program	N/A

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

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Apr 30, 2024
• Anticipated Study Completion Date: Jul 31, 2024

Arms and Interventions

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

Primary Outcome Measures

1. Substance use: Alcohol [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 [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 [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 [Past 30-day period]

   Attitudes towards drug use Scale

2. Intention to use alcohol [Next 30-day period]

   Intention to drug use in the next month Scale

3. Intention to use tobacco [Next 30-day period]

   Intention to drug use in the next month Scale

4. Intention to use cannabis [Next 30-day period]

   Intention to drug use in the next month Scale

5. Academic performance [Past 12-months period]

   Assessed as having repeated grades

6. Emotion regulation [Past 30-day period]

   Cognitive Emotion Regulation Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

• Principal Investigator: Montserrat Juan, PhD, Instituto Europeo de Estudios en Prevención

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Instituto Europeo de Estudios en Prevención
• ClinicalTrials.gov Identifier: NCT05950074
• Other Study ID Numbers: 2021F055 Tu decides
• First Posted: Jul 18, 2023
• Last Update Posted: Jul 18, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Substance-Related Disorders; Alcohol Drinking; Behavior, Addictive

Study Results

No Results Posted as of Jul 18, 2023