Clinical trial NCT04236947: Effectiveness of the Social Competence Promotion Program for Young Adolescents for Substance Use Prevention in Chile
Official title: Randomized Control Trial of the Effectiveness of the Social Competence Promotion Program for Young Adolescents Aimed at Preventing Substance Use Among Students in Chile
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance Use
Keywords: Adolescents
Prevention
School
Social Competence Promotion Program for Young Adolescents
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
Collaborators: name: Comisión Nacional de Investigación Científica y Tecnológica
name: University of Talca
First posted: 2020-01-22
Enrollment: 600
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized control trial with two arms.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Schools having primary education (Year 1 to Year 8)
2. Schools located in Santiago (Chile)
3. Schools having a vulnerability index (School Vulnerability Index - National System of Equality Allocation (IVE-SINAE)) ≥ 50%\*
4. Mixed-sex schools.
5. 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.

Primary outcomes:
measure: Cigarette use in the last month
timeFrame: Past 30-day period
Secondary outcomes:
measure: Alcohol use in the last month
timeFrame: Past 30-day period
measure: Marijuana use in the last month
timeFrame: Past 30-day period
measure: Social problem-solving
timeFrame: Last 3 months
measure: Emotional regulation
timeFrame: Last 3 months
measure: Socio-emotional skills
timeFrame: Last 3 months
measure: Sense of school membership
timeFrame: Last 3 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad de los Andes
Study officials:
References:
citation: Gaete J, Inzunza C, Ramirez S, Valenzuela D, Rojas C, Araya R. The Social Competence Promotion Program among Young Adolescents (SCPP-YA) in Chile ("Mi Mejor Plan") for substance use prevention among early adolescents: study protocol for a randomized controlled trial. Trials. 2022 Jun 30;23(1):542. doi: 10.1186/s13063-022-06472-w.