"Juego de LLaves": Study Protocol of a Universal School-based Drug Use Prevention Program (PSIDUP) (PSIDUP)

"Juego de Llaves", a Universal School-based Drug Use Prevention Program: A Non-Randomized Control Cluster Trial for the Evaluation of Effectiveness Among Adolescents in Spain (PISUP)

"Juego de Llaves" is a universal school-based drug prevention program for adolescents aged 12-15 years. The outcome evaluation is critical to determine the quality of preventive interventions. This protocol describes the full protocol of the evaluation design, instruments, randomization procedure, follow-ups, and primary outcomes. Method: Non-Randomized Control Cluster Trial in a set of Spanish school centers at the compulsory secondary education level, with follow-ups at 12-, 24- and 36-months. Participants will be allocated to an experimental or control (no intervention) group. Using an electronic ad-hoc designed App, a battery of instruments will be used to assess addictive behaviors, sociodemographic variables, school climate and other transdiagnostic psychological variables. A piloting test will be conducted to test the implementation protocol and to calculate the sample size needed for the outcome evaluation. After implementing the program, longitudinal statistical approaches will be used to inform on the intervention efficacy and potential moderators and mediators. There is a lack of effectiveness assessments of school prevention programs, and it is expected that this protocol will expedite the monitoring and ongoing evaluation in prevention.

Study Overview

• Status: Not yet recruiting
• Conditions: Behavior, Addictive; Adolescent Behavior; Alcohol Abuse; Smoking Behaviors; Psychological; Adolescent - Emotional Problem
• Intervention / Treatment: Behavioral: Juego de Llaves

• Study Type: Interventional
• Enrollment (Anticipated): 2500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susana Al-Halabí, PhD; Phone Number: +34 985104199; Email: alsusana@uniovi.es

Study Locations

• Spain
  • Asturias
    • Oviedo, Asturias, Spain, 33006
      • Grupo de Conductas Adictivas, University of Oviedo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Schools having other interventions with a strong package on substance use prevention targeted the same grades.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Juego de Llaves group; This group will receive the prevention program during the academic year in school hours. The prevention program is called Juego de Llaves. The main goal of this program is to prevent substance use and engagement in other addictive behaviors. It is intended to be delivered by teachers in a six to twelve session format through different modules that cover the following areas: emotional regulation, cognitive strategies, social interaction, free time, education on drugs and life values	Behavioral: Juego de Llaves; The main goal of this program is to prevent substance use and engagement in other addictive behaviors. It is intended to be delivered by teachers in a six to twelve session format through different modules that cover the following areas: emotional regulation, cognitive strategies, social interaction, free time, education on drugs and life values
No Intervention: Control group; The control group will receive the usual teaching activities regarding substance use prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substance use: Tobacco	Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs	Past 30-day period
Substance use: Alcohol	Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs	Past 30-day period
Substance use: Cannabis	Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs	Past 30-day period
Non-substance use behavior: Gaming	Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs	Past 30-day period
Non-substance use behavior: Gambling	Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs	Past 30-day period
Reinforcement ratio	Ad-hoc questionnaire (SAUPI; unpublished)	Past-year period
Consecuences of addictive behaviors	ARSS-SUV (adapted from Murphy et al., 2005)	Past 30-day period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resilience	The Child and Youth Resilience Measure, CYMR (Resilience Research Centre, 2018)	Past 30-day period
Behavioral problemas	Strengths and Difficulties Questionnaire (25-item version), SDQ (Ortuño-Sierra et al., 2018)	Past 30-day period
Emotion regulation	The Emotional Regulation Questionnaire - adolescents, ERQ-CA (Navarro et al., 2018)	Past 30-day period
Suicidal behavior	The Paykel Suicide Scale, PSS (Fonseca-Pedrero et al., 2018)	Past 30-day period
Impulsivity	The Scale of Impulsivity for Children and Adolescents BUPPS-P-NA (Caneto et al., 2020)	Past 30-day period

Collaborators and Investigators

• Sponsor: Susana Al-Halabí
• Collaborators: United Nations Office on Drugs and Crime (UNODC); Asociación Proyecto Hombre

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Adolescents; Evaluation; Universal school-based prevention; Transdiagnostic approach; Addictive behaviors
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Compulsive Behavior; Impulsive Behavior; Alcoholism; Behavior, Addictive
• Other Study ID Numbers: 2021G090 / FUO-22- 023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No