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Substance UseYSLQQNCT04236999

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

A study testing Yo Sé Lo Que Quiero (YSLQQ) in people with Substance Use, run by Universidad de los Andes, Chile at 1 site in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Substance Use
What is being tested?
Yo Sé Lo Que Quiero (YSLQQ)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8,880 participants
Where
1 siteChile
Study dates
1 Sep 2021to 31 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Jorge Gaete, PhD contact

+56940245650

jgaete@uandes.cl

Sofía Gana, MSc contact

+56978996973

sgana@miuandes.cl

Chile1 site, 1 recruiting
  • Universidad de los Andes

    Santiago

    Jorge Gaete, PhD, +56940245650, jgaete@uandes.cl

    Sofía Gana, MSc, +56978996973, sgana@miuandes.cl

    Recruiting

Other trials in Chile

About this 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.

Read more

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.

Read the 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). Most of substance use disorders start during adolescence, and it is well known that the earlier the use of any substance of abuse, the higher the risk for drug dependence later in life. For example, if alcohol use starts at 14 or earlier, the risk for alcohol dependence during adulthood is five or more times when compared to those individuals who start using alcohol after 21 years old.

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.

Even though the great effort made by the Government of Chile during many years, offering several universal and targeted school-based interventions, the results are somehow frustrating. For example, the Chilean National Strategic Plan for Drugs 2003-2009 had the goal of reducing drug use in school-age population. However, during the same period cannabis and other illegal drugs use increased. Later, the Chilean National Plan for Drugs and Alcohol 2011-2014, had the goals, among school-age population, of reducing the annual prevalence of cannabis and alcohol use by 15%, and the annual prevalence of cocaine use by 10%. However, annual prevalence of cannabis use dramatically increased from 19.5% in 2011 to 34.2% in 2015; and the annual prevalence of alcohol increased from 59.3% in 2011 to 63.0% in 2015. Similar trend is seen in the annual prevalence of cocaine use, increasing from 3.2% in 2011 to 4.2% in 2015.

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.

A recent systematic review found that the "Unplugged" program appears to have the best evidence of effectiveness, tested in several European countries. This universal school-based program targets students aged 12-14 years and aims to prevent all substance of abuse with special focus on tobacco, alcohol and marijuana. It is delivered by trained teachers in 12 sessions or units over a period of one academic year and includes teaching factual knowledge and attitudes regarding drug use (4 sessions), and training in interpersonal skills (4 sessions), and intrapersonal skills (4 sessions). No previous evaluation of this program has been carried out in Chile.

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. This design is the most stringent design to test the effectiveness of an intervention. Investigators plan to include 37 mixed-sex schools, with a vulnerability index (School Vulnerability Index - National System of Equality Allocation (IVESINAE)) ≥ 50%, with at least two classes per Year 6 and Year 7, in each arm (Intervention vs. Control) (n=4440 students per arm). The control schools will receive the usual teaching and practice in drug prevention.

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
Being tested
Yo Sé Lo Que Quiero (YSLQQ)
Keywords
Adolescents, Unplugged, Prevention, Schools
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yo Sé Lo Que Quiero (YSLQQ)Behavioural

    Also called Unplugged

    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.
Study groups in NCT04236999
Study groupRoleWhat they receive
YSLQQ groupExperimentalThis 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.
Receives: Behavioral: Yo Sé Lo Que Quiero (YSLQQ)
Control groupNo interventionThe control group will receive the usual teaching activities regarding substance use prevention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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"

    Measured: Past 30-day period

Secondary outcomes (3)
  1. Weekly cigarette use

    Students will be asked: How many cigarettes participants usually smoke per week? Answers will range from "0" to "20 or more cigarettes"

    Measured: Past 7 days

  2. Past year marihuana use

    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"

    Measured: Past 12-month period

  3. Knowledge and opinion about substance use

    Students will be asked several questions regarding the Knowledge and opinion about substance use, using a validated questionnaire.

    Measured: Past 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2020
  2. Study start1 Sep 2021
  3. Primary completion31 Mar 2023 (estimated)
  4. Study completion31 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
8,880 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04236999
Sponsor's protocol ID
Fondecyt Regular 1181724
Acronym
YSLQQ
Status last verified
Nov 2021
First submitted
17 Jan 2020
Last updated
10 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Investigators plan to deposit the data collected in this study in the "UK Data Service". Data sharing will never compromise participant privacy, neither schools nor students.

Publications

  • 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.

    PubMed 35078522

Questions about this trial

What is this clinical trial studying?

A study testing Yo Sé Lo Que Quiero (YSLQQ) in people with Substance Use, run by Universidad de los Andes, Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jorge Gaete, PhD (+56940245650, jgaete@uandes.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Past month drunkenness (time frame: Past 30-day period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04236999, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.

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