NCT04236999: YSLQQ

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

Status unknown NA Last updated 10 November 2021

What this trial tests

NA trial testing Yo Sé Lo Que Quiero (YSLQQ) in Substance Use in 8,880 participants. Status unknown.

Timeline

1 September 2021

Primary endpoint
31 March 2023

31 March 2023

Quick facts

Lead sponsor	Universidad de los Andes, Chile
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	8,880
Start date	1 September 2021
Primary completion	31 March 2023
Estimated completion	31 March 2023
Sites	1 location across Chile

Drugs / interventions tested

• Yo Sé Lo Que Quiero (YSLQQ)

Conditions studied

• Substance Use — all drugs for Substance Use →

Sponsor

Universidad de los Andes, Chile — full company profile →

Who can join

Adults 10 to 15, any sex, with Substance Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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). 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Validation of the European Drug Addiction Prevention Trial Questionnaire (EU-Dap) for substance use screening and to assess risk and protective factors among early adolescents in Chile.
   Ramírez S, Gana S, Godoy MI, Valenzuela D, et al · · 2021 · cited 9× · PMID 34634082 · DOI 10.1371/journal.pone.0258288
2. The Unplugged program in Chile ("Yo Sé Lo Que Quiero") for substance use prevention among early adolescents: study protocol for a randomized controlled trial.
   Gaete J, Ramírez S, Gana S, Valenzuela D, et al · · 2022 · cited 2× · PMID 35078522 · DOI 10.1186/s13063-021-05904-3