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

NCT04566627 | Completed

• 1 other identifier: Fondecyt Regular 1181724 Pilot
• Study Type: interventional
• Target: 1,214
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use; Adolescent Behavior

Outcome Measures

Primary Outcomes (2)

• 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.

  Inmediately Post-intervention

• 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.

  1 year

Secondary Outcomes (2)

• EU-Dap

  One month

• SURPS

  One month

Study Arms (2)

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.

Behavioral: "Yo Sé Lo Que Quiero" programl

Control Group

NO INTERVENTION

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

Interventions

"Yo Sé Lo Que Quiero" programl BEHAVIORAL

"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.

Also known as: Unplugged, Todojunto

YSLQQ group

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• Comisión Nacional de Investigación Científica y Tecnológica: collaborator

Study Sites (1)

Universidad de los Andes

Santiago, 7620060, Chile

Location

Related Publications (9)

• 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.

  PMID: 18657569 RESULT

• 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.

  PMID: 20080363 RESULT

• 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.

  PMID: 24753279 RESULT

• 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.

  PMID: 17084887 RESULT

• 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.

  PMID: 26894657 RESULT

• 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.

  PMID: 28361199 RESULT

• 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.

  PMID: 26441044 RESULT

• 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.

  PMID: 19683400 RESULT

• Salgado G, Gaete J, Gana S, Valenzuela D, Araya R. Acceptability, feasibility and fidelity of the culturally adapted version of Unplugged ("Yo Se Lo Que Quiero"), a substance use preventive program among adolescents in Chile: a pilot randomized controlled study. BMC Public Health. 2024 Jul 29;24(1):2026. doi: 10.1186/s12889-024-19499-2.

  PMID: 39075465 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Adolescent Behavior

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Jorge Gaete, MD PhD

  Universidad de los Andes, Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluators were blinded to the intervention condition of the schools.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 28, 2020
• Study Start: March 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 30, 2019
• Last Updated: September 28, 2020

Record last verified: 2020-09

Locations

CL (1)