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

NCT05442294 | Unknown

• 1 other identifier: 2021G090 / FUO-22- 023
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Adolescents; Addictive behaviors; Evaluation; Universal school-based prevention; Transdiagnostic approach

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Resilience

  Past 30-day period

• Behavioral problemas

  Past 30-day period

• Emotion regulation

  Past 30-day period

• Suicidal behavior

  Past 30-day period

• Impulsivity

  Past 30-day period

Study Arms (2)

Juego de Llaves group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Juego de Llaves BEHAVIORAL

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

Juego de Llaves group

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Susana Al-Halabí: lead
• United Nations Office on Drugs and Crime (UNODC): collaborator
• Asociación Proyecto Hombre: collaborator

Study Sites (1)

Grupo de Conductas Adictivas, University of Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Behavior, Addictive; Alcoholism; Smoking; Adolescent Behavior

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Susana Al-Halabí, PhD

CONTACT

+34 985104199; alsusana@uniovi.es

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 INVESTIGATOR
• PI Title: Associate Professor at the Department of Psychology

Model Details: Non-Randomized Control Cluster Trial

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: July 1, 2022
• Study Start: September 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2025
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

ES (1)