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Unplugged, a Drug Use Prevention Program: Adaptation and Evaluation of Effectiveness Among Students in Chile (YSLQQ)

Primary Purpose

Substance Use

Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Yo Sé Lo Que Quiero (YSLQQ)
Sponsored by
Universidad de los Andes, Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use focused on measuring Adolescents, Unplugged, Prevention, Schools

Eligibility Criteria

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

Inclusion Criteria:

  1. Schools having primary education (Year 1 to Year 8)
  2. Schools located in Santiago (Chile)
  3. Schools having a vulnerability index (School Vulnerability Index - National System of Equality Allocation (IVE-SINAE)) ≥ 50%*
  4. Mixed-sex schools.
  5. Schools having at least 2 classes in 6th and 7th grades.
  6. Schools willing to participate under the conditions of the study before randomization.

    • The IVE-SINAE is built taking into account several students' and parental variables: health, family income, receiving state benefits. This percentage means the proportion of students in a school who are in most need.

Exclusion Criteria:

1. Schools having other interventions with a strong package on substance use prevention targeted the same grades.

Sites / Locations

  • Universidad de los AndesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

YSLQQ group

Control group

Arm Description

This group will receive the prevention program during the academic year in school hours. The prevention program is called Unplugged in its original name, but the adaptation made by the research team for Chile is called "Yo Sé Lo Que Quiero" (YSLQQ). 12 one-hour sessions taught once a week by class teachers, previously trained in a 3-day course. Each session will be delivered during the time of "Orientation" lessons.

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

Outcomes

Primary Outcome Measures

Past month drunkenness
Students will be asked: During the last 30 days, how many times participants have been drunk for drinking alcoholic beverages? Answers will range from "0" to "30 or more times"

Secondary Outcome Measures

Weekly cigarette use
Students will be asked: How many cigarettes participants usually smoke per week? Answers will range from "0" to "20 or more cigarettes"
Past year marihuana use
Students will be asked: How many times, during the last 12 months, participants have consumed marihuana? Answers will range from "0" to "30 or more times"
Knowledge and opinion about substance use
Students will be asked several questions regarding the Knowledge and opinion about substance use, using a validated questionnaire.

Full Information

First Posted
January 17, 2020
Last Updated
November 8, 2021
Sponsor
Universidad de los Andes, Chile
Collaborators
Comisión Nacional de Investigación Científica y Tecnológica
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1. Study Identification

Unique Protocol Identification Number
NCT04236999
Brief Title
Unplugged, a Drug Use Prevention Program: Adaptation and Evaluation of Effectiveness Among Students in Chile
Acronym
YSLQQ
Official Title
Unplugged, a Drug Use Prevention Program: Adaptation and Evaluation of Effectiveness Among Students in Chile
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de los Andes, Chile
Collaborators
Comisión Nacional de Investigación Científica y Tecnológica

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
Substance use and drug related disorders are important public health problems. Alcohol and illicit drug use account for 5.4% of the total burden of disease and the peak has been found in early adulthood (between ages 20 and 30 years). Substance use is one of the leading problems among Chilean adolescents. One out of four 8 th to 12 th graders have smoked cigarettes in the last month. A 35.6% of students (37%, girls; 34.2%, boys) between Year 8 and Year 12 have reported any alcohol use during the last month. It is worrying that a third of 14 years old students report using alcohol in the last month in Chile. Furthermore, two out of three who are using alcohol, report regularly using 5 or more drinks in a row during the last month. Cannabis use among young Chileans has increased in recent years. Today, one out of five students between Year 8 and Year 12 referred cannabis use during the last 30 days. Almost a 20% of students in Year 8 have used cannabis in the last year. Therefore, is urgent to provide evidence-based drug preventive interventions to the Chilean population, specifically to school students, to tackle this problem and reduce the risk for a more dramatic future health scenario. The aim of this study is to develop a culturally appropriate version of the Unplugged program to the Chilean culture, and to test its effectiveness among early adolescents in low-income primary schools in Santiago, Chile. This project involves two stages: first, formative work, where the research team will review, adapt and pilot the Spanish version of the program to Chile; and second, the culturally adapted version of Unplugged program will be tested in a single-blind two-arm cluster randomized controlled trial. At the end of the intervention, investigators expect that students in schools receiving the Chilean version of Unplugged will have a lower proportion of substance use and a lower proportion of students passing from experimental use to regular use of tobacco, alcohol, and cannabis, than in control schools.
Detailed Description
Substance use and drug related disorders are important public health problems. Alcohol and illicit drug use account for 5.4% of the total burden of disease and the peak has been found in early adulthood (between ages 20 and 30 years). Most of substance use disorders start during adolescence, and it is well known that the earlier the use of any substance of abuse, the higher the risk for drug dependence later in life. For example, if alcohol use starts at 14 or earlier, the risk for alcohol dependence during adulthood is five or more times when compared to those individuals who start using alcohol after 21 years old. Substance use is one of the leading problems among Chilean adolescents. One out of four 8 th to 12 th graders have smoked cigarettes in the last month. A 35.6% of students (37%, girls; 34.2%, boys) between Year 8 and Year 12 have reported any alcohol use during the last month. It is worrying that a third of 14 years old students report using alcohol in the last month in Chile. Furthermore, two out of three who are using alcohol, report regularly using 5 or more drinks in a row during the last month. Cannabis use among young Chileans has increased in recent years. Today, one out of five students between Year 8 and Year 12 referred cannabis use during the last 30 days. Almost a 20% of students in Year 8 have used cannabis in the last year. Even though the great effort made by the Government of Chile during many years, offering several universal and targeted school-based interventions, the results are somehow frustrating. For example, the Chilean National Strategic Plan for Drugs 2003-2009 had the goal of reducing drug use in school-age population. However, during the same period cannabis and other illegal drugs use increased. Later, the Chilean National Plan for Drugs and Alcohol 2011-2014, had the goals, among school-age population, of reducing the annual prevalence of cannabis and alcohol use by 15%, and the annual prevalence of cocaine use by 10%. However, annual prevalence of cannabis use dramatically increased from 19.5% in 2011 to 34.2% in 2015; and the annual prevalence of alcohol increased from 59.3% in 2011 to 63.0% in 2015. Similar trend is seen in the annual prevalence of cocaine use, increasing from 3.2% in 2011 to 4.2% in 2015. Therefore, is urgent to provide evidence-based drug preventive interventions to the Chilean population, specifically to school students, to tackle this problem and reduce the risk for a more dramatic future health scenario. A recent systematic review found that the "Unplugged" program appears to have the best evidence of effectiveness, tested in several European countries. This universal school-based program targets students aged 12-14 years and aims to prevent all substance of abuse with special focus on tobacco, alcohol and marijuana. It is delivered by trained teachers in 12 sessions or units over a period of one academic year and includes teaching factual knowledge and attitudes regarding drug use (4 sessions), and training in interpersonal skills (4 sessions), and intrapersonal skills (4 sessions). No previous evaluation of this program has been carried out in Chile. The aim of this study is to develop a culturally appropriate version of the Unplugged program to the Chilean culture, and to test its effectiveness among early adolescents in low-income primary schools in Santiago, Chile. This project involves two stages: first, formative work, where the research team will review, adapt and pilot the Spanish version of the program to Chile; and second, the culturally adapted version of Unplugged program will be tested in a single-blind two-arm cluster randomized controlled trial. This design is the most stringent design to test the effectiveness of an intervention. Investigators plan to include 37 mixed-sex schools, with a vulnerability index (School Vulnerability Index - National System of Equality Allocation (IVESINAE)) ≥ 50%, with at least two classes per Year 6 and Year 7, in each arm (Intervention vs. Control) (n=4440 students per arm). The control schools will receive the usual teaching and practice in drug prevention. At the end of the intervention, investigators expect that students in schools receiving the Chilean version of Unplugged will have a lower proportion of substance use and a lower proportion of students passing from experimental use to regular use of tobacco, alcohol, and cannabis, than in control schools.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
Keywords
Adolescents, Unplugged, Prevention, Schools

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized controlled trial
Masking
Outcomes Assessor
Masking Description
In all the assessments, research assistants will be blind to the trial arm where the schools/students were allocated.
Allocation
Randomized
Enrollment
8880 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
YSLQQ 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 Unplugged in its original name, but the adaptation made by the research team for Chile is called "Yo Sé Lo Que Quiero" (YSLQQ). 12 one-hour sessions taught once a week by class teachers, previously trained in a 3-day course. Each session will be delivered during the time of "Orientation" lessons.
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)
Yo Sé Lo Que Quiero (YSLQQ)
Other Intervention Name(s)
Unplugged
Intervention Description
This program is organized in 12 sessions around three themes: Knowledge and attitudes (sessions 1, 3, 5 and 9): Students reflect on their knowledge of legal and illegal drugs, using critical thinking to obtain an objective assessment of this knowledge. Intrapersonal skills (sessions 4, 6, 8, 10. 11. and 12): Activities are carried out where students can put themselves in everyday situations and develop skills such as assertiveness, problem solving, among others. Interpersonal skills (sessions 2 and 7): Students are instructed to practice refusal skills, assertiveness, and analyze coping strategies.
Primary Outcome Measure Information:
Title
Past month drunkenness
Description
Students will be asked: During the last 30 days, how many times participants have been drunk for drinking alcoholic beverages? Answers will range from "0" to "30 or more times"
Time Frame
Past 30-day period
Secondary Outcome Measure Information:
Title
Weekly cigarette use
Description
Students will be asked: How many cigarettes participants usually smoke per week? Answers will range from "0" to "20 or more cigarettes"
Time Frame
Past 7 days
Title
Past year marihuana use
Description
Students will be asked: How many times, during the last 12 months, participants have consumed marihuana? Answers will range from "0" to "30 or more times"
Time Frame
Past 12-month period
Title
Knowledge and opinion about substance use
Description
Students will be asked several questions regarding the Knowledge and opinion about substance use, using a validated questionnaire.
Time Frame
Past 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Schools having primary education (Year 1 to Year 8) Schools located in Santiago (Chile) Schools having a vulnerability index (School Vulnerability Index - National System of Equality Allocation (IVE-SINAE)) ≥ 50%* Mixed-sex schools. Schools having at least 2 classes in 6th and 7th grades. Schools willing to participate under the conditions of the study before randomization. The IVE-SINAE is built taking into account several students' and parental variables: health, family income, receiving state benefits. This percentage means the proportion of students in a school who are in most need. Exclusion Criteria: 1. 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
Jorge Gaete, PhD
Phone
+56940245650
Email
jgaete@uandes.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Sofía Gana, MSc
Phone
+56978996973
Email
sgana@miuandes.cl
Facility Information:
Facility Name
Universidad de los Andes
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Gaete, PhD
Phone
+56940245650
Email
jgaete@uandes.cl
First Name & Middle Initial & Last Name & Degree
Sofía Gana, MSc
Phone
+56978996973
Email
sgana@miuandes.cl
First Name & Middle Initial & Last Name & Degree
Jorge Gaete, PhD
First Name & Middle Initial & Last Name & Degree
Daniela Valenzuela, MSc
First Name & Middle Initial & Last Name & Degree
Ricardo Araya, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Investigators plan to deposit the data collected in this study in the "UK Data Service". Data sharing will never compromise participant privacy, neither schools nor students.
Citations:
PubMed Identifier
35078522
Citation
Gaete J, Ramirez S, Gana S, Valenzuela D, Araya R. The Unplugged program in Chile ("Yo Se Lo Que Quiero") for substance use prevention among early adolescents: study protocol for a randomized controlled trial. Trials. 2022 Jan 25;23(1):76. doi: 10.1186/s13063-021-05904-3.
Results Reference
derived

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Unplugged, a Drug Use Prevention Program: Adaptation and Evaluation of Effectiveness Among Students in Chile

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