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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jorge Gaete, PhD
- Telefonnummer: +56226182277
- E-post: jgaete@uandes.cl
Studera Kontakt Backup
- Namn: Natalia Ríos, BA
- Telefonnummer: +56978783002
- E-post: nmrios@miuandes.cl
Studieorter
-
-
-
Santiago, Chile
- Rekrytering
- Universidad De Los Andes
-
Huvudutredare:
- Jorge Gaete, PhD
-
Underutredare:
- Daniela Valenzuela, MSc
-
Underutredare:
- Ricardo Araya, PhD
-
Kontakt:
- Jorge Gaete, PhD
- Telefonnummer: +56226182277
- E-post: jgaete@uandes.cl
-
Kontakt:
- Constanza Inzunza, BA
- Telefonnummer: +56987104930
- E-post: cminzunza@miuandes.cl
-
Underutredare:
- Marcela Cárcamo, MSc
-
Underutredare:
- Cristian Rojas, PhD
-
Underutredare:
- Roger Weissberg, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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).
|
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.
Andra namn:
|
|
Inget ingripande: Control Group
The control schools will continue providing their traditional preventive actions.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cigarette use in the last month
Tidsram: Past 30-day period
|
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
|
Past 30-day period
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Alcohol use in the last month
Tidsram: Past 30-day period
|
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
|
Past 30-day period
|
|
Marijuana use in the last month
Tidsram: Past 30-day period
|
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
|
Past 30-day period
|
|
Social problem-solving
Tidsram: Last 3 months
|
Measured with Social Problem-Solving Inventory, short version.
This is a 25-item instrument that measures several problem-solving skills.
|
Last 3 months
|
|
Emotional regulation
Tidsram: Last 3 months
|
Measured with Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA).This is a 10-item instrument that measures emotional regulation.
|
Last 3 months
|
|
Socio-emotional skills
Tidsram: Last 3 months
|
Measured with Strengths and Difficulties Questionnaire (SDQ).
This is a 25-item instrument that measures emotional, conduct, peer and hyperactivity/inattention problems
|
Last 3 months
|
|
Sense of school membership
Tidsram: Last 3 months
|
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.
|
Last 3 months
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FONIS SA19I0115
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .