NCT05950074

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

June 20, 2023

Last Update Submit

March 6, 2024

Conditions

Substance UseBehavior, AddictiveSmoking BehaviorsAlcohol DrinkingIllicit Drug Use

Outcome Measures

Primary Outcomes (3)

  • Substance use: Alcohol

    Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs

    Past 30-day period

  • Substance use: Tobacco

    Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs

    Past 30-day period

  • Substance use: Cannabis

    Items from the survey on drug use in secondary education in Spain for the National Plan on Drugs

    Past 30-day period

Secondary Outcomes (6)

  • Attitudes toward substance use

    Past 30-day period

  • Intention to use alcohol

    Next 30-day period

  • Intention to use tobacco

    Next 30-day period

  • Intention to use cannabis

    Next 30-day period

  • Academic performance

    Past 12-months period

  • +1 more secondary outcomes

Study Arms (2)

"It´s Up To You" program

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

"It´s Up To You" programBEHAVIORAL

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.

"It´s Up To You" program

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Schools having secondary education
  • Schools located in Spain.
  • Schools willing to participate under the conditions of the study

You may not qualify if:

  • Schools applying the original "It´s Up To You" prevention program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Europeo de Estudios en Prevención

Palma de Mallorca, Spain

Location

Related Publications (1)

  • Castano Y, Gervilla E, Martinez-Vispo C, Juan M, Garcia-Pazo P, Al-Halabi S, Becona E, Calafat A. Effectiveness of a School-Based Drug Prevention Program: Tu Decides 2.0. J Prev (2022). 2025 Nov 17. doi: 10.1007/s10935-025-00883-6. Online ahead of print.

    PMID: 41247593DERIVED

MeSH Terms

Conditions

Substance-Related DisordersBehavior, AddictiveSmokingAlcohol Drinking

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehaviorDrinking Behavior

Study Officials

  • Montserrat Juan, PhD

    Instituto Europeo de Estudios en Prevención

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2023

First Posted

July 18, 2023

Study Start

October 1, 2023

Primary Completion

April 30, 2024

Study Completion

July 31, 2024

Last Updated

March 8, 2024

Record last verified: 2024-03

Locations

ES(1)