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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Behavior, Addictive, Adolescent - Emotional Problem, Alcohol Abuse, Smoking Behaviors, Adolescent Behavior, Psychological

Intervention / Treatment
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* Behavioral: Juego de Llaves


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-Randomized Control Cluster Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Juego de Llaves group<br>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<br>* 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<br>|
| No Intervention: Control group<br>The control group will receive the usual teaching activities regarding substance use prevention. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transdiagnostic approach, Adolescents, Addictive behaviors, Evaluation, Universal school-based prevention