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

Alcohol Abuse Clinical Trial

— 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05442294
• Other study ID #: 2021G090 / FUO-22- 023
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2022
• Source: University of Oviedo
• Contact: Susana Al-Halabí, PhD
• Phone: +34 985104199
• Email: alsusana[@]uniovi.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2500
• Est. completion date: December 30, 2025
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Spain	Grupo de Conductas Adictivas, University of Oviedo	Oviedo	Asturias

Sponsors (3)

Lead Sponsor	Collaborator
Susana Al-Halabí	Asociación Proyecto Hombre, United Nations Office on Drugs and Crime (UNODC)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Reinforcement ratio	Ad-hoc questionnaire (SAUPI; unpublished)	Past-year period
Primary	Consecuences of addictive behaviors	ARSS-SUV (adapted from Murphy et al., 2005)	Past 30-day period
Secondary	Resilience	The Child and Youth Resilience Measure, CYMR (Resilience Research Centre, 2018)	Past 30-day period
Secondary	Behavioral problemas	Strengths and Difficulties Questionnaire (25-item version), SDQ (Ortuño-Sierra et al., 2018)	Past 30-day period
Secondary	Emotion regulation	The Emotional Regulation Questionnaire - adolescents, ERQ-CA (Navarro et al., 2018)	Past 30-day period
Secondary	Suicidal behavior	The Paykel Suicide Scale, PSS (Fonseca-Pedrero et al., 2018)	Past 30-day period
Secondary	Impulsivity	The Scale of Impulsivity for Children and Adolescents BUPPS-P-NA (Caneto et al., 2020)	Past 30-day period

External Links

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