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

Primary Purpose

Behavior, Addictive, Adolescent - Emotional Problem, Alcohol Abuse

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Juego de Llaves
Sponsored by
Susana Al-Halabí
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Behavior, Addictive focused on measuring Adolescents, Addictive behaviors, Evaluation, Universal school-based prevention, Transdiagnostic approach

Eligibility Criteria

12 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Grupo de Conductas Adictivas, University of Oviedo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Juego de Llaves group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Substance use: Tobacco
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Substance use: Alcohol
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Substance use: Cannabis
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Non-substance use behavior: Gaming
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Non-substance use behavior: Gambling
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Reinforcement ratio
Ad-hoc questionnaire (SAUPI; unpublished)
Consecuences of addictive behaviors
ARSS-SUV (adapted from Murphy et al., 2005)

Secondary Outcome Measures

Resilience
The Child and Youth Resilience Measure, CYMR (Resilience Research Centre, 2018)
Behavioral problemas
Strengths and Difficulties Questionnaire (25-item version), SDQ (Ortuño-Sierra et al., 2018)
Emotion regulation
The Emotional Regulation Questionnaire - adolescents, ERQ-CA (Navarro et al., 2018)
Suicidal behavior
The Paykel Suicide Scale, PSS (Fonseca-Pedrero et al., 2018)
Impulsivity
The Scale of Impulsivity for Children and Adolescents BUPPS-P-NA (Caneto et al., 2020)

Full Information

First Posted
June 15, 2022
Last Updated
June 28, 2022
Sponsor
Susana Al-Halabí
Collaborators
United Nations Office on Drugs and Crime (UNODC), Asociación Proyecto Hombre
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1. Study Identification

Unique Protocol Identification Number
NCT05442294
Brief Title
"Juego de LLaves": Study Protocol of a Universal School-based Drug Use Prevention Program (PSIDUP)
Acronym
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susana Al-Halabí
Collaborators
United Nations Office on Drugs and Crime (UNODC), Asociación Proyecto Hombre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior, Addictive, Adolescent - Emotional Problem, Alcohol Abuse, Smoking Behaviors, Adolescent Behavior, Psychological
Keywords
Adolescents, Addictive behaviors, Evaluation, Universal school-based prevention, Transdiagnostic approach

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-Randomized Control Cluster Trial
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
2500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Juego de Llaves group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive the usual teaching activities regarding substance use prevention.
Intervention Type
Behavioral
Intervention Name(s)
Juego de Llaves
Intervention Description
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
Primary Outcome Measure Information:
Title
Substance use: Tobacco
Description
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Time Frame
Past 30-day period
Title
Substance use: Alcohol
Description
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Time Frame
Past 30-day period
Title
Substance use: Cannabis
Description
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Time Frame
Past 30-day period
Title
Non-substance use behavior: Gaming
Description
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Time Frame
Past 30-day period
Title
Non-substance use behavior: Gambling
Description
Ítems from the survey on drug use in secondary education in Spain (ESTUDES) for the National Plan on Drugs
Time Frame
Past 30-day period
Title
Reinforcement ratio
Description
Ad-hoc questionnaire (SAUPI; unpublished)
Time Frame
Past-year period
Title
Consecuences of addictive behaviors
Description
ARSS-SUV (adapted from Murphy et al., 2005)
Time Frame
Past 30-day period
Secondary Outcome Measure Information:
Title
Resilience
Description
The Child and Youth Resilience Measure, CYMR (Resilience Research Centre, 2018)
Time Frame
Past 30-day period
Title
Behavioral problemas
Description
Strengths and Difficulties Questionnaire (25-item version), SDQ (Ortuño-Sierra et al., 2018)
Time Frame
Past 30-day period
Title
Emotion regulation
Description
The Emotional Regulation Questionnaire - adolescents, ERQ-CA (Navarro et al., 2018)
Time Frame
Past 30-day period
Title
Suicidal behavior
Description
The Paykel Suicide Scale, PSS (Fonseca-Pedrero et al., 2018)
Time Frame
Past 30-day period
Title
Impulsivity
Description
The Scale of Impulsivity for Children and Adolescents BUPPS-P-NA (Caneto et al., 2020)
Time Frame
Past 30-day period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susana Al-Halabí, PhD
Phone
+34 985104199
Email
alsusana@uniovi.es
Facility Information:
Facility Name
Grupo de Conductas Adictivas, University of Oviedo
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://proyectohombre.es/juego-de-llaves-eso/
Description
Related Info

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

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