Acceptability and Feasibility Study of the Program "Yo Se Lo Que Quiero" (Unplugged) (YSLQQ-Pilot)

September 22, 2020 updated by: Jorge Gaete, Universidad de los Andes, Chile

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile, 7620060
        • Universidad de Los Andes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: YSLQQ group
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.
Behavioral: "Yo Sé Lo Que Quiero" programl
"Yo Sé Lo Que Quiero" program 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.
Other Names:
  • Unplugged
  • Todojunto
No Intervention: Control Group
Schools in this group implemented the usual preventive actions to reduce substance use. Usually, these actions are not manualized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Inmediately Post-intervention
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EU-Dap
Time Frame: One month

The European Drug Addiction Prevention Trial Questionnaire (EU-Dap) was the instrument used to evaluate the Unplugged drug prevention program among adolescents in The European Drug Addiction Prevention (EU-Dap) trial project which took place between 2003-2005. EU-Dap was granted by the European Commission within the 2002 and 2005 Public Health Programme for drug prevention (Grant #SPC 2002376 and Grant #SPC 2005312).

This questionnaire collects information, knowledge and opinions on substance use, with emphasis on alcohol, tobacco and drugs use. It also gather information about tobacco, alcohol, marijuana and other drugs use; and assess risk and protective factors. It consists of 45 questions. In the Chilean validation, all subscales had an acceptable internal reliability (omega > 0.65).
One month
SURPS
Time Frame: One month
The Substance Use Risk Profile Scale, is a self-reported questionnaire that gather information about anxiety sensitivity, hopelessness, sensation seeking, and impulsivity. These four sub scales have been associated as risk factors for drug use among adolescents. the internal reliability for each subscale is: anxiety sensitivity (alpha=0.65), hopelessness (alpha=0.76), sensation seeking (alpha=0.62), and impulsivity (alpha=0.61).
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de los Andes, Chile

Collaborators

Comisión Nacional de Investigación Científica y Tecnológica

Investigators

  • Principal Investigator: Jorge Gaete, MD PhD, Universidad de los Andes, Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

September 17, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 28, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 22, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fondecyt Regular 1181724 Pilot

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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