Effectiveness of the Social Competence Promotion Program for Young Adolescents for Substance Use Prevention in Chile

NCT ID: NCT04236947

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-05-30

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.

Conditions

Substance Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

SCPP-YA

Intervention Type: BEHAVIORAL

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.

Control Group

The control schools will continue providing their traditional preventive actions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SCPP-YA

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Social Competence Promotion Program for Young Adolescents; New Haven Program; Mi Mejor Plan

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Comisión Nacional de Investigación Científica y Tecnológica

OTHER_GOV

Sponsor Role: collaborator

University of Talca

OTHER

Sponsor Role: collaborator

Universidad de los Andes, Chile

OTHER

Sponsor Role: lead

Responsible Party

Jorge Gaete

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad de los Andes

Santiago, , Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Jorge Gaete, PhD

Role: CONTACT

jgaete@uandes.cl

+56226182277

Natalia Rios, BA

Role: CONTACT

nmrios@miuandes.cl

+56978783002

Facility Contacts

Jorge Gaete, PhD

Role: primary

jgaete@uandes.cl

+56226182277

Constanza Inzunza, BA

Role: backup

cminzunza@miuandes.cl

+56987104930

References

Ramirez S, Rios N, Rojas-Barahona CA, Carcamo M, Sepulveda-Panaloza A, Araya R, Gaete J. Acceptability, feasibility, fidelity and quality implementation of the culturally adapted version of the Social Competence Promotion Program among Young Adolescents ("Mi Mejor Plan") to prevent substance use among adolescents in Chile: a pilot randomized control study. BMC Public Health. 2025 May 20;25(1):1860. doi: 10.1186/s12889-025-23033-3.

Reference Type: DERIVED

PMID: 40394545 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35773714 (View on PubMed)

Other Identifiers

FONIS SA19I0115

Identifier Type: -

Identifier Source: org_study_id