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

Susana Al-Halabí

Status: Not yet enrolling

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

Treatments: Behavioral: Juego de Llaves

Study type: Interventional

Funder types: Other

Identifiers

NCT05442294

2021G090 / FUO-22- 023

Details and patient eligibility

About

"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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 12 to 15 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,500 participants in 2 patient groups

Juego de Llaves group

Experimental group

Description:

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

Treatment:

Behavioral: Juego de Llaves

Control group

No Intervention group

Description:

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