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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8880 participants|
|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.|
|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|
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:
Other Name: Unplugged
No Intervention: Control group
The control group will receive the usual teaching activities regarding substance use prevention.
- 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"
- 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"
- 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"
- 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.
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
|Contact: Jorge Gaete, PhDfirstname.lastname@example.org|
|Contact: Sofía Gana, MScemail@example.com|
|Universidad de los Andes||Recruiting|
|Contact: Jorge Gaete, PhD +56940245650 firstname.lastname@example.org|
|Contact: Sofía Gana, MSc +56978996973 email@example.com|
|Principal Investigator: Jorge Gaete, PhD|
|Sub-Investigator: Daniela Valenzuela, MSc|
|Sub-Investigator: Ricardo Araya, PhD|