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Clinical Trials/NCT04566627
NCT04566627CompletedNot Applicable

Acceptability and Feasibility Study of the Program "Yo Se Lo Que Quiero" (Unplugged) Aiming to Reduce Substance Use Among Adolescents in Chile: a Pilot Randomized Controlled Study.

Universidad de los Andes, Chile1 site in 1 country1,214 target enrollmentStarted: March 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,214
Locations
1
Primary Endpoint
Feasibility of the program

Study Overview

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 was to assess the acceptability and feasibility of the cultural adaptation of "Yo Sé Lo Que Quiero" program. This is a pilot randomized controlled trial. The participants of this pilot were students attending six low-income primary schools in Santiago, Chile.

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). 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 was to assess the acceptability and feasibility of the cultural adaptation of "Yo Sé Lo Que Quiero" program. This is a pilot randomized controlled trial. The participants of this pilot were students attending six low-income primary schools in Santiago, Chile.

This pilot study is part of a larger research project with the final aim of testing the effectiveness of "Yo Sé Lo Que Quiero" program to reduce substance use among adolescents in Chile.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

Evaluators were blinded to the intervention condition of the schools.

Eligibility Criteria

Ages
11 Years to 15 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • for schools:
  • Mixed schools (boys and girls)
  • Schools with a high vulnerability index, IVESINAE > 70%. The IVESINAE is an indicator of the proportion of the students who have several risk factors regarding family income, parental education among other factors. This index is built by the Ministry of Education in Chile and help to direct resources to the schools.
  • Located in the Metropolitan region in Chile.

Exclusion Criteria

  • for schools:
  • Having a structure and manualized substance use preventive program in place.

Arms & Interventions

YSLQQ group

Experimental

Schools in this group implemented "Yo Sé Lo Que Quiero" program. This is the cultural adaptation of the Unplugged program. This is a preventive intervention to reduce tobacco, alcohol, and marihuana use among adolescents. It consists of 12 sessions, delivered by a trained facilitator on a weekly basis.

Intervention: "Yo Sé Lo Que Quiero" programl (Behavioral)

Control Group

No Intervention

Schools in this group implemented the usual preventive actions to reduce substance use. Usually, these actions are not manualized.

Outcomes

Primary Outcomes

Feasibility of the program

Time Frame: 1 year

A register was used to determine the number of schools initially contacted and the number of schools that accepted to participate; number of students that consented and assented to participate in the study at baseline and at follow-up; the number of sessions planned and actually delivered; the number of schools and teachers that participated in the training.

Acceptability of the program by students

Time Frame: Inmediately Post-intervention

A questionnaire exploring the acceptability of the program was answered by the students who participated in the intervention. This questionnaire asked about the students´opinions about the content of the intervention, strategies used, materials, and performance of the facilitators. The questionnaire also asked about satisfaction and the helpfulness of the program to improve emotions management, school climate, relationships with other people, and learning about drugs´ risks. Finally, the questionnaire asked about sense of self-efficacy to avoid drugs today and in the future.

Secondary Outcomes

  • EU-Dap(One month)
  • SURPS(One month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jorge Gaete

Associate Professor

Universidad de los Andes, Chile

Study Sites (1)

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