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.
Обзор исследования
Подробное описание
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.
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Jorge Gaete, PhD
- Номер телефона: +56226182277
- Электронная почта: jgaete@uandes.cl
Учебное резервное копирование контактов
- Имя: Natalia Ríos, BA
- Номер телефона: +56978783002
- Электронная почта: nmrios@miuandes.cl
Места учебы
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Santiago, Чили
- Рекрутинг
- Universidad De Los Andes
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Главный следователь:
- Jorge Gaete, PhD
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Младший исследователь:
- Daniela Valenzuela, MSc
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Младший исследователь:
- Ricardo Araya, PhD
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Контакт:
- Jorge Gaete, PhD
- Номер телефона: +56226182277
- Электронная почта: jgaete@uandes.cl
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Контакт:
- Constanza Inzunza, BA
- Номер телефона: +56987104930
- Электронная почта: cminzunza@miuandes.cl
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Младший исследователь:
- Marcela Cárcamo, MSc
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Младший исследователь:
- Cristian Rojas, PhD
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Младший исследователь:
- Roger Weissberg, PhD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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.
Другие имена:
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Без вмешательства: Control Group
The control schools will continue providing their traditional preventive actions.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Cigarette use in the last month
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Alcohol use in the last month
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- FONIS SA19I0115
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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