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

• ClinicalTrials.gov Identifier: NCT05950074
• Recruitment Status: Active, not recruiting
• First Posted: July 18, 2023
• Last Update Posted: March 8, 2024
• Sponsor: Instituto Europeo de Estudios en Prevención
• 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

Tracking Information

• First Submitted Date: June 20, 2023
• First Posted Date: July 18, 2023
• Last Update Posted Date: March 8, 2024
• Actual Study Start Date: October 1, 2023
• Estimated Primary Completion Date: April 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 14, 2023)

• 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
• 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
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 14, 2023)

• Attitudes toward substance use [ Time Frame: Past 30-day period ]
  Attitudes towards drug use Scale
• Intention to use alcohol [ Time Frame: Next 30-day period ]
  Intention to drug use in the next month Scale
• Intention to use tobacco [ Time Frame: Next 30-day period ]
  Intention to drug use in the next month Scale
• Intention to use cannabis [ Time Frame: Next 30-day period ]
  Intention to drug use in the next month Scale
• Academic performance [ Time Frame: Past 12-months period ]
  Assessed as having repeated grades
• Emotion regulation [ Time Frame: Past 30-day period ]
  Cognitive Emotion Regulation Questionnaire

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention

Condition

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

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.

Study Arms

• 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.
  Intervention: Behavioral: "It´s Up To You" program
• No Intervention: Control
  The control group will receive the usual teaching activities regarding substance use prevention.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 14, 2023): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 31, 2024
• Estimated Primary Completion Date: April 30, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 17 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT05950074
• Other Study ID Numbers: 2021F055 Tu decides
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Instituto Europeo de Estudios en Prevención
• Original Responsible Party: Same as current
• Current Study Sponsor: Instituto Europeo de Estudios en Prevención
• Original Study Sponsor: Same as current

Collaborators

• 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

• PRS Account: Instituto Europeo de Estudios en Prevención
• Verification Date: March 2024