search
Back to results

Effectiveness of the Social Competence Promotion Program for Young Adolescents for Substance Use Prevention in Chile (SCPP-YA)

Primary Purpose

Substance Use

Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
SCPP-YA
Sponsored by
Universidad de los Andes, Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use focused on measuring Adolescents, Prevention, School, Social Competence Promotion Program for Young Adolescents

Eligibility Criteria

9 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidad de los AndesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SCPP-YA group

Control Group

Arm Description

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).

The control schools will continue providing their traditional preventive actions.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Social problem-solving
Measured with Social Problem-Solving Inventory, short version. This is a 25-item instrument that measures several problem-solving skills.
Emotional regulation
Measured with Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA).This is a 10-item instrument that measures emotional regulation.
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
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.

Full Information

First Posted
January 17, 2020
Last Updated
March 18, 2022
Sponsor
Universidad de los Andes, Chile
Collaborators
Comisión Nacional de Investigación Científica y Tecnológica, University of Talca
search

1. Study Identification

Unique Protocol Identification Number
NCT04236947
Brief Title
Effectiveness of the Social Competence Promotion Program for Young Adolescents for Substance Use Prevention in Chile
Acronym
SCPP-YA
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de los Andes, Chile
Collaborators
Comisión Nacional de Investigación Científica y Tecnológica, University of Talca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
Keywords
Adolescents, Prevention, School, Social Competence Promotion Program for Young Adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a randomized control trial with two arms.
Masking
Outcomes Assessor
Masking Description
During the assessments, research assistants will be blind to the allocation of schools.
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SCPP-YA group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control schools will continue providing their traditional preventive actions.
Intervention Type
Behavioral
Intervention Name(s)
SCPP-YA
Other Intervention Name(s)
Social Competence Promotion Program for Young Adolescents, New Haven Program, Mi Mejor Plan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cigarette use in the last month
Description
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
Secondary Outcome Measure Information:
Title
Alcohol use in the last month
Description
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
Title
Marijuana use in the last month
Description
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
Title
Social problem-solving
Description
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
Title
Emotional regulation
Description
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
Title
Socio-emotional skills
Description
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
Title
Sense of school membership
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Gaete, PhD
Phone
+56226182277
Email
jgaete@uandes.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Rios, BA
Phone
+56978783002
Email
nmrios@miuandes.cl
Facility Information:
Facility Name
Universidad de los Andes
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Gaete, PhD
Phone
+56226182277
Email
jgaete@uandes.cl
First Name & Middle Initial & Last Name & Degree
Constanza Inzunza, BA
Phone
+56987104930
Email
cminzunza@miuandes.cl
First Name & Middle Initial & Last Name & Degree
Jorge Gaete, PhD
First Name & Middle Initial & Last Name & Degree
Daniela Valenzuela, MSc
First Name & Middle Initial & Last Name & Degree
Marcela Cárcamo, MSc
First Name & Middle Initial & Last Name & Degree
Cristian Rojas, PhD
First Name & Middle Initial & Last Name & Degree
Ricardo Araya, PhD
First Name & Middle Initial & Last Name & Degree
Roger Weissberg, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigators plan to share data using "UK Data Service". The investigators will never compromise participant privacy, neither schools nor students.
Citations:
PubMed Identifier
35773714
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs