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

NCT04236947 | Unknown

• 1 other identifier: FONIS SA19I0115
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use

Keywords

Adolescents; Prevention; School; Social Competence Promotion Program for Young Adolescents

Outcome Measures

Primary Outcomes (1)

• 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

  Past 30-day period

Secondary Outcomes (6)

• Alcohol use in the last month

  Past 30-day period

• Marijuana use in the last month

  Past 30-day period

• Social problem-solving

  Last 3 months

• Emotional regulation

  Last 3 months

• Socio-emotional skills

  Last 3 months

Study Arms (2)

SCPP-YA group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

The control schools will continue providing their traditional preventive actions.

Interventions

SCPP-YA 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.

Also known as: Social Competence Promotion Program for Young Adolescents, New Haven Program, Mi Mejor Plan

SCPP-YA group

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \. Schools that are implementing other substance use prevention program similar to the contents and methodology of "Mi Mejor Plan" targeting the same grade.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• Comisión Nacional de Investigación Científica y Tecnológica: collaborator
• University of Talca: collaborator

Study Sites (1)

Universidad de los Andes

Santiago, Chile

RECRUITING

Related Publications (2)

• 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.

  PMID: 40394545 DERIVED

• 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.

  PMID: 35773714 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Jorge Gaete, PhD

CONTACT

+56226182277; jgaete@uandes.cl

Natalia Rios, BA

CONTACT

+56978783002; nmrios@miuandes.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: During the assessments, research assistants will be blind to the allocation of schools.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study is a randomized control trial with two arms.

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 22, 2020
• Study Start: March 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: May 30, 2023
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

CL (1)