Clinical trial NCT05442294: "Juego de LLaves": Study Protocol of a Universal School-based Drug Use Prevention Program (PSIDUP)
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Behavior, Addictive
Adolescent - Emotional Problem
Alcohol Abuse
Smoking Behaviors
Adolescent Behavior
Psychological
Keywords: Adolescents
Addictive behaviors
Evaluation
Universal school-based prevention
Transdiagnostic approach
Lead sponsor: University of Oviedo
Sponsor class: OTHER
Collaborators: name: United Nations Office on Drugs and Crime (UNODC)
name: Asociación Proyecto Hombre
First posted: 2022-07-01
Enrollment: 2500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-Randomized Control Cluster Trial
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Substance use: Tobacco
timeFrame: Past 30-day period
measure: Substance use: Alcohol
timeFrame: Past 30-day period
measure: Substance use: Cannabis
timeFrame: Past 30-day period
measure: Non-substance use behavior: Gaming
timeFrame: Past 30-day period
measure: Non-substance use behavior: Gambling
timeFrame: Past 30-day period
measure: Reinforcement ratio
timeFrame: Past-year period
measure: Consecuences of addictive behaviors
timeFrame: Past 30-day period
Secondary outcomes:
measure: Resilience
timeFrame: Past 30-day period
measure: Behavioral problemas
timeFrame: Past 30-day period
measure: Emotion regulation
timeFrame: Past 30-day period
measure: Suicidal behavior
timeFrame: Past 30-day period
measure: Impulsivity
timeFrame: Past 30-day period
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Grupo de Conductas Adictivas, University of Oviedo
state: Asturias
Study officials:
References: