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

NCT04236999 | Unknown

• 1 other identifier: Fondecyt Regular 1181724
• Study Type: interventional
• Target: 8,880
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use

Keywords

Adolescents; Unplugged; Prevention; Schools

Outcome Measures

Primary Outcomes (1)

• 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"

  Past 30-day period

Secondary Outcomes (3)

• Weekly cigarette use

  Past 7 days

• Past year marihuana use

  Past 12-month period

• Knowledge and opinion about substance use

  Past 6 months

Study Arms (2)

YSLQQ group

EXPERIMENTAL

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)

Control group

NO INTERVENTION

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

Interventions

Yo Sé Lo Que Quiero (YSLQQ) BEHAVIORAL

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.

Also known as: Unplugged

YSLQQ group

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• Comisión Nacional de Investigación Científica y Tecnológica: collaborator

Study Sites (1)

Universidad de los Andes

Santiago, Chile

RECRUITING

Related Publications (1)

• 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.

  PMID: 35078522 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Jorge Gaete, PhD

CONTACT

+56940245650; jgaete@uandes.cl

Sofía Gana, MSc

CONTACT

+56978996973; sgana@miuandes.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In all the assessments, research assistants will be blind to the trial arm where the schools/students were allocated.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Cluster randomized controlled trial

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 22, 2020
• Study Start: September 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: November 10, 2021

Record last verified: 2021-11

Locations

CL (1)