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- Klinische proef NCT04236947
Effectiveness of the Social Competence Promotion Program for Young Adolescents for Substance Use Prevention in Chile (SCPP-YA)
Randomized Control Trial of the Effectiveness of the Social Competence Promotion Program for Young Adolescents Aimed at Preventing Substance Use Among Students in Chile
Substance use has become a significant public health problem, given its magnitude and the treatment gap encountered when a dependency disorder has already been installed. Still, to date, there are no studies in Chile that show the effectiveness of a universal preventive program implemented in educational settings, using a randomized controlled clinical trial design.
This study consists of evaluating the effectiveness of the Social Competence Promotion Program among Young Adolescents (SCPP-YA), which aims to postpone the onset of substance use and reduce their consumption.
This is a randomized controlled clinical trial with two arms, including students of 6th grade from high socioeconomic vulnerability schools in Santiago. The primary outcome is the incidence of tobacco consumption in the last month.
The SCPP-YA consists of 16 sessions that will be implemented during the academic year (2020) and complemented with three booster sessions the following year (2021). This intervention mainly provides strategies for self-regulation, problem-solving, and substance use prevention.
The investigators expect that students in the intervention group will delay the onset of any substance use, especially tobacco, alcohol, and marijuana when compared with students in the control group.
Studie Overzicht
Gedetailleerde beschrijving
Chilean adolescents face problems in their mental health and risk behaviors, which compromise their development. Among these behaviors, substance use has become a significant public health problem, given its magnitude and the treatment gap encountered when a dependency disorder has already been installed. In Chile, both prevention and treatment were among the Sanitary Aims of the 2010-2020 decade. For many years, different governmental and non-governmental institutions have implemented preventive initiatives in the school population. Still, to date, there are no studies in Chile that show the effectiveness of a universal preventive program implemented in educational settings, using a randomized controlled clinical trial design.
This study consists of evaluating the effectiveness of the Social Competence Promotion Program among Young Adolescents (SCPP-YA), which aims to postpone the onset of substance use and reduce their consumption.
This is a randomized controlled clinical trial with two arms, including students of 6th grade from high socioeconomic vulnerability schools in Santiago. Ten schools will be randomly allocated to the intervention group and the control group in a 1:1 ratio. Assessments of students will be carried out at baseline, post-intervention, and 12 months after the end of the intervention. The primary outcome is the incidence of tobacco consumption in the last month. The SCPP-YA consists of 10 student sessions providing self-regulation strategies, promotion of prosocial skills, and a method of problem-solving. Additionally, it includes a 6-session module specially designed for substance use prevention. These 16 sessions will be implemented during the academic year (2020) and complemented with three booster sessions the following year (2021).
The investigators expect that students in the intervention group will delay the onset of any substance use, especially tobacco, alcohol, and marijuana when compared with students in the control group.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Jorge Gaete, PhD
- Telefoonnummer: +56226182277
- E-mail: jgaete@uandes.cl
Studie Contact Back-up
- Naam: Natalia Rios, BA
- Telefoonnummer: +56978783002
- E-mail: nmrios@miuandes.cl
Studie Locaties
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Santiago, Chili
- Werving
- Universidad de Los Andes
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Hoofdonderzoeker:
- Jorge Gaete, PhD
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Onderonderzoeker:
- Daniela Valenzuela, MSc
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Onderonderzoeker:
- Ricardo Araya, PhD
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Contact:
- Jorge Gaete, PhD
- Telefoonnummer: +56226182277
- E-mail: jgaete@uandes.cl
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Contact:
- Constanza Inzunza, BA
- Telefoonnummer: +56987104930
- E-mail: cminzunza@miuandes.cl
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Onderonderzoeker:
- Marcela Cárcamo, MSc
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Onderonderzoeker:
- Cristian Rojas, PhD
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Onderonderzoeker:
- Roger Weissberg, PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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 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.
Exclusion Criteria:
1. Schools that are implementing other substance use prevention program similar to the contents and methodology of "Mi Mejor Plan" targeting the same grade.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: SCPP-YA group
SCPP-YA adapted to Chile consist of ten sessions promoting self-regulation strategies, prosocial, and problem-solving skills.
It also includes a module (6 sessions) specially designed for substance use prevention, developing social competence, and assertiveness to deal with peer pressure.
These 16 sessions will be implemented during an academic year (2020), and complemented with three booster sessions the following year (2021).
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SCPP-YA includes two modules.
In the first module of ten sessions, students will learn to employ a 6-step social information processing framework for solving a wide range of real-life problems.
The six-step process consists of 1) stop, clam down, and think before you act; 2) say the problem and how you feel; 3) set a positive goal; 4) think of many solutions; 5) think ahead to the consequences and 6) go ahead and try the best plan.
The second module offers 1) current and accurate information about the health, social, and legal consequences of substance use, 2) correct mistaken beliefs that students have about substance use, 3) enhances awareness of social and media influences; and 4) teachers assertiveness and critical thinking skills to resist peer pressure.
Andere namen:
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Geen tussenkomst: Control Group
The control schools will continue providing their traditional preventive actions.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Cigarette use in the last month
Tijdsspanne: Past 30-day period
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Measured with the European Drug Addiction Prevention Trial Questionnaire (EU-Dap) validated in Chile.
Students will be asked: How many times participants have smoked cigarettes in the last 30 days
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Past 30-day period
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Alcohol use in the last month
Tijdsspanne: Past 30-day period
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Measured with the European Drug Addiction Prevention Trial Questionnaire (EU-Dap) validated in Chile.
Students will be asked: How many times participants have drink alcohol beverages in the last 30 days
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Past 30-day period
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Marijuana use in the last month
Tijdsspanne: Past 30-day period
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Measured with the European Drug Addiction Prevention Trial Questionnaire (EU-Dap) validated in Chile.
Students will be asked: How many times participants have consumed marijuana in the last 30 days
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Past 30-day period
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Social problem-solving
Tijdsspanne: Last 3 months
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Measured with Social Problem-Solving Inventory, short version.
This is a 25-item instrument that measures several problem-solving skills.
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Last 3 months
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Emotional regulation
Tijdsspanne: Last 3 months
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Measured with Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA).This is a 10-item instrument that measures emotional regulation.
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Last 3 months
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Socio-emotional skills
Tijdsspanne: Last 3 months
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Measured with Strengths and Difficulties Questionnaire (SDQ).
This is a 25-item instrument that measures emotional, conduct, peer and hyperactivity/inattention problems
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Last 3 months
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Sense of school membership
Tijdsspanne: Last 3 months
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Measured with the Psychological Sense of School Membership scale (PSSM).
This is a scale with 13 items that refers to the student's perceptions of the respect and acceptance that teachers and other students show him or her, as well as his or her sense of belonging.
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Last 3 months
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Medewerkers en onderzoekers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- FONIS SA19I0115
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
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Duke UniversityNational Institute of Mental Health (NIMH); National Institute for Medical Research... en andere medewerkersWervingAanhankelijkheid, medicatie | HIV-1-infectie | Geestelijke gezondheidskwestieTanzania
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Hoya Surgical Optics, Inc.VoltooidAfakieVerenigde Staten
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John Jay College of Criminal Justice, City University...Indiana University School of MedicineWervingJeugd | Eerste aflevering PsychoseVerenigde Staten
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Syeda AYAT E ZAINAB AliPakistan Institute of Living and Learning; MinPlan OrganizationWerving