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.
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jorge Gaete, PhD
- Número de teléfono: +56226182277
- Correo electrónico: jgaete@uandes.cl
Copia de seguridad de contactos de estudio
- Nombre: Natalia Ríos, BA
- Número de teléfono: +56978783002
- Correo electrónico: nmrios@miuandes.cl
Ubicaciones de estudio
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Santiago, Chile
- Reclutamiento
- Universidad De Los Andes
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Investigador principal:
- Jorge Gaete, PhD
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Sub-Investigador:
- Daniela Valenzuela, MSc
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Sub-Investigador:
- Ricardo Araya, PhD
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Contacto:
- Jorge Gaete, PhD
- Número de teléfono: +56226182277
- Correo electrónico: jgaete@uandes.cl
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Contacto:
- Constanza Inzunza, BA
- Número de teléfono: +56987104930
- Correo electrónico: cminzunza@miuandes.cl
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Sub-Investigador:
- Marcela Cárcamo, MSc
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Sub-Investigador:
- Cristian Rojas, PhD
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Sub-Investigador:
- Roger Weissberg, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
Otros nombres:
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Sin intervención: Control Group
The control schools will continue providing their traditional preventive actions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cigarette use in the last month
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Alcohol use in the last month
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FONIS SA19I0115
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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