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

Primary Purpose

Substance Use, Adolescent Behavior

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
"Yo Sé Lo Que Quiero" programl
Sponsored by
Universidad de los Andes, Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use

Eligibility Criteria

11 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidad de los Andes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

YSLQQ group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Acceptability of the program by students
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.
Feasibility of the program
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.

Secondary Outcome Measures

EU-Dap
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).
SURPS
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).

Full Information

First Posted
September 17, 2020
Last Updated
September 22, 2020
Sponsor
Universidad de los Andes, Chile
Collaborators
Comisión Nacional de Investigación Científica y Tecnológica
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1. Study Identification

Unique Protocol Identification Number
NCT04566627
Brief Title
Acceptability and Feasibility Study of the Program "Yo Se Lo Que Quiero" (Unplugged)
Acronym
YSLQQ-Pilot
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de los Andes, Chile
Collaborators
Comisión Nacional de Investigación Científica y Tecnológica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Adolescent Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of two groups in parallel for the duration of the study.
Masking
Outcomes Assessor
Masking Description
Evaluators were blinded to the intervention condition of the schools.
Allocation
Randomized
Enrollment
1214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YSLQQ group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Schools in this group implemented the usual preventive actions to reduce substance use. Usually, these actions are not manualized.
Intervention Type
Behavioral
Intervention Name(s)
"Yo Sé Lo Que Quiero" programl
Other Intervention Name(s)
Unplugged, Todojunto
Intervention Description
"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.
Primary Outcome Measure Information:
Title
Acceptability of the program by students
Description
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.
Time Frame
Inmediately Post-intervention
Title
Feasibility of the program
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
EU-Dap
Description
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).
Time Frame
One month
Title
SURPS
Description
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).
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Gaete, MD PhD
Organizational Affiliation
Universidad de los Andes, Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de los Andes
City
Santiago
ZIP/Postal Code
7620060
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
18657569
Citation
Faggiano F, Galanti MR, Bohrn K, Burkhart G, Vigna-Taglianti F, Cuomo L, Fabiani L, Panella M, Perez T, Siliquini R, van der Kreeft P, Vassara M, Wiborg G; EU-Dap Study Group. The effectiveness of a school-based substance abuse prevention program: EU-Dap cluster randomised controlled trial. Prev Med. 2008 Nov;47(5):537-43. doi: 10.1016/j.ypmed.2008.06.018. Epub 2008 Jul 9.
Results Reference
result
PubMed Identifier
20080363
Citation
Faggiano F, Vigna-Taglianti F, Burkhart G, Bohrn K, Cuomo L, Gregori D, Panella M, Scatigna M, Siliquini R, Varona L, van der Kreeft P, Vassara M, Wiborg G, Galanti MR; EU-Dap Study Group. The effectiveness of a school-based substance abuse prevention program: 18-month follow-up of the EU-Dap cluster randomized controlled trial. Drug Alcohol Depend. 2010 Apr 1;108(1-2):56-64. doi: 10.1016/j.drugalcdep.2009.11.018. Epub 2010 Jan 18.
Results Reference
result
PubMed Identifier
24753279
Citation
Vigna-Taglianti FD, Galanti MR, Burkhart G, Caria MP, Vadrucci S, Faggiano F; EU-Dap Study Group. "Unplugged," a European school-based program for substance use prevention among adolescents: overview of results from the EU-Dap trial. New Dir Youth Dev. 2014 Spring;2014(141):67-82, 11-2. doi: 10.1002/yd.20087.
Results Reference
result
PubMed Identifier
17084887
Citation
Faggiano F, Richardson C, Bohrn K, Galanti MR; EU-Dap Study Group. A cluster randomized controlled trial of school-based prevention of tobacco, alcohol and drug use: the EU-Dap design and study population. Prev Med. 2007 Feb;44(2):170-3. doi: 10.1016/j.ypmed.2006.09.010. Epub 2006 Nov 3.
Results Reference
result
PubMed Identifier
26894657
Citation
Prado MC, Schneider DR, Sanudo A, Pereira AP, Horr JF, Sanchez ZM. Transcultural Adaptation of Questionnaire to Evaluate Drug Use Among Students: The Use of the EU-Dap European Questionnaire in Brazil. Subst Use Misuse. 2016;51(4):449-58. doi: 10.3109/10826084.2015.1117108. Epub 2016 Feb 19.
Results Reference
result
PubMed Identifier
28361199
Citation
Sanchez ZM, Valente JY, Sanudo A, Pereira APD, Cruz JI, Schneider D, Andreoni S. The #Tamojunto Drug Prevention Program in Brazilian Schools: a Randomized Controlled Trial. Prev Sci. 2017 Oct;18(7):772-782. doi: 10.1007/s11121-017-0770-8.
Results Reference
result
PubMed Identifier
26441044
Citation
Newton NC, Barrett EL, Castellanos-Ryan N, Kelly E, Champion KE, Stapinski L, Conrod PJ, Slade T, Nair N, Teesson M. The validity of the Substance Use Risk Profile Scale (SURPS) among Australian adolescents. Addict Behav. 2016 Feb;53:23-30. doi: 10.1016/j.addbeh.2015.09.015. Epub 2015 Sep 25.
Results Reference
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PubMed Identifier
19683400
Citation
Woicik PA, Stewart SH, Pihl RO, Conrod PJ. The Substance Use Risk Profile Scale: a scale measuring traits linked to reinforcement-specific substance use profiles. Addict Behav. 2009 Dec;34(12):1042-55. doi: 10.1016/j.addbeh.2009.07.001. Epub 2009 Jul 8.
Results Reference
result

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

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