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

Sponsor

Susana Al-Halabí (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05442294

Collaborator

United Nations Office on Drugs and Crime (UNODC) (Other), Asociación Proyecto Hombre (Other)

2,500

Enrollment

Location

Arms

Anticipated Duration (Months)

62.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

"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.

Condition or Disease	Intervention/Treatment	Phase
Behavior, Addictive Adolescent - Emotional Problem Alcohol Abuse Smoking Behaviors Adolescent Behavior Psychological	Behavioral: Juego de Llaves	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2500 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Non-Randomized Control Cluster TrialNon-Randomized Control Cluster Trial

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

"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)

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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Ad-hoc questionnaire (SAUPI; unpublished)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

Secondary Outcome Measures

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