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

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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05442294
Acronym
PSIDUP
Enrollment
2500
Registered
2022-07-01
Start date
2022-09-01
Completion date
2025-12-30
Last updated
2022-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

BEHAVIORALJuego 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

Sponsors

United Nations Office on Drugs and Crime (UNODC)
CollaboratorOTHER_GOV
Asociación Proyecto Hombre
CollaboratorUNKNOWN
Susana Al-Halabí
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Non-Randomized Control Cluster Trial

Eligibility

Sex/Gender
ALL
Age
12 Years to 15 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Consecuences of addictive behaviorsPast 30-day periodARSS-SUV (adapted from Murphy et al., 2005)
Substance use: AlcoholPast 30-day periodÍtems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Substance use: CannabisPast 30-day periodÍtems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Non-substance use behavior: GamingPast 30-day periodÍtems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Non-substance use behavior: GamblingPast 30-day periodÍtems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Reinforcement ratioPast-year periodAd-hoc questionnaire (SAUPI; unpublished)
Substance use: TobaccoPast 30-day periodÍtems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs

Secondary

MeasureTime frameDescription
Behavioral problemasPast 30-day periodStrengths and Difficulties Questionnaire (25-item version), SDQ (Ortuño-Sierra et al., 2018)
Emotion regulationPast 30-day periodThe Emotional Regulation Questionnaire - adolescents, ERQ-CA (Navarro et al., 2018)
Suicidal behaviorPast 30-day periodThe Paykel Suicide Scale, PSS (Fonseca-Pedrero et al., 2018)
ImpulsivityPast 30-day periodThe Scale of Impulsivity for Children and Adolescents BUPPS-P-NA (Caneto et al., 2020)
ResiliencePast 30-day periodThe Child and Youth Resilience Measure, CYMR (Resilience Research Centre, 2018)

Countries

Spain

Contacts

Primary ContactSusana Al-Halabí, PhD
alsusana@uniovi.es+34 985104199

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026