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

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ClinicalTrials.gov Identifier: NCT04236999
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
Comisión Nacional de Investigación Científica y Tecnológica
Information provided by (Responsible Party):
Jorge Gaete, Universidad de los Andes, Chile

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.


Condition or disease Intervention/treatment Phase
Substance Use Behavioral: Yo Sé Lo Que Quiero (YSLQQ) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8880 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: In all the assessments, research assistants will be blind to the trial arm where the schools/students were allocated.
Primary Purpose: Prevention
Official Title: Unplugged, a Drug Use Prevention Program: Adaptation and Evaluation of Effectiveness Among Students in Chile
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 23, 2021
Estimated Study Completion Date : December 23, 2021

Arm Intervention/treatment
Experimental: YSLQQ group
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.
Behavioral: Yo Sé Lo Que Quiero (YSLQQ)

This program is organized in 12 sessions around three themes:

  • Knowledge and attitudes (1 st to 4 th sessions): students reflect on their knowledge of legal and illegal drugs, using tests to reach an objective assessment of this knowledge.
  • Intrapersonal skills (5 th to 6 th sessions): students reflect on normative beliefs, where perceived prevalence of drug use at students' age is compared with the actual local prevalence.
  • Interpersonal skills (7 th to 12 th sessions): students are instructed to practice refusal skills, assertiveness, and analyze coping strategies. They also are instructed and practice how to make decisions using a five-step model.
Other Name: Unplugged

No Intervention: Control group
The control group will receive the usual teaching activities regarding substance use prevention.



Primary Outcome Measures :
  1. Past month drunkenness [ Time Frame: Past 30-day period ]
    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 :
  1. Weekly cigarette use [ Time Frame: Past 7 days ]
    Students will be asked: How many cigarettes participants usually smoke per week? Answers will range from "0" to "20 or more cigarettes"

  2. Past year marihuana use [ Time Frame: Past 12-month period ]
    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"

  3. Knowledge and opinion about substance use [ Time Frame: Past 6 months ]
    Students will be asked several questions regarding the Knowledge and opinion about substance use, using a validated questionnaire.



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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)) ≥ 70%*
  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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236999


Contacts
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Contact: Jorge Gaete, PhD +56940245650 jgaete@uandes.cl
Contact: Sofía Gana, MSc +56978996973 sgana@miuandes.cl

Locations
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Chile
Universidad de los Andes Recruiting
Santiago, Chile
Contact: Jorge Gaete, PhD    +56940245650    jgaete@uandes.cl   
Contact: Sofía Gana, MSc    +56978996973    sgana@miuandes.cl   
Principal Investigator: Jorge Gaete, PhD         
Sub-Investigator: Daniela Valenzuela, MSc         
Sub-Investigator: Ricardo Araya, PhD         
Sponsors and Collaborators
Universidad de los Andes, Chile
Comisión Nacional de Investigación Científica y Tecnológica

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Responsible Party: Jorge Gaete, Associate Professor, Universidad de los Andes, Chile
ClinicalTrials.gov Identifier: NCT04236999    
Other Study ID Numbers: Fondecyt Regular 1181724
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jorge Gaete, Universidad de los Andes, Chile:
Adolescents
Unplugged
Prevention
Schools