Alcohol Abuse Clinical Trial
— PSIDUPOfficial 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)
"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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Grupo de Conductas Adictivas, University of Oviedo | Oviedo | Asturias |
Lead Sponsor | Collaborator |
---|---|
Susana Al-Halabí | Asociación Proyecto Hombre, United Nations Office on Drugs and Crime (UNODC) |
Spain,
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 |
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