An interventional study of SCPP-YA in Substance Use, sponsored by Universidad de los Andes, Chile. Status unknown at 1 site in Chile. Open to participants aged 9 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-01.
Sponsored by Universidad de los Andes, Chile · Not applicable, Interventional, and Prevention
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.
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.
2,181 studies on the registry are indexed under Substance-Related Disorders; 399 are open to participants now.
This study's planned enrollment of 600 is above the median of 108 across 1,770 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Universidad de los Andes, Chile is the lead sponsor of 46 studies on the registry; 10 are open to participants now.
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Schools willing to participate under the conditions of the study before randomization.
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.
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).
Behavioral: SCPP-YA
The control schools will continue providing their traditional preventive actions.
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.
Also known as: Social Competence Promotion Program for Young Adolescents, New Haven Program, Mi Mejor Plan
Cigarette use in the last month
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
Time frame: Past 30-day period
Alcohol use in the last month
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
Time frame: Past 30-day period
Marijuana use in the last month
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
Time frame: Past 30-day period
Social problem-solving
Measured with Social Problem-Solving Inventory, short version. This is a 25-item instrument that measures several problem-solving skills.
Time frame: Last 3 months
Emotional regulation
Measured with Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA).This is a 10-item instrument that measures emotional regulation.
Time frame: Last 3 months
Socio-emotional skills
Measured with Strengths and Difficulties Questionnaire (SDQ). This is a 25-item instrument that measures emotional, conduct, peer and hyperactivity/inattention problems
Time frame: Last 3 months
Sense of school membership
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.
Time frame: Last 3 months
Plan to share: Undecided — The investigators plan to share data using "UK Data Service". The investigators will never compromise participant privacy, neither schools nor students.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Universidad de los Andes, Chile