Effectiveness of the Social Competence Promotion Program for Young Adolescents for Substance Use Prevention in Chile (SCPP-YA)
Randomized Control Trial of the Effectiveness of the Social Competence Promotion Program for Young Adolescents Aimed at Preventing Substance Use Among Students in Chile
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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Jorge Gaete, PhD
- Puhelinnumero: +56226182277
- Sähköposti: jgaete@uandes.cl
Tutki yhteystietojen varmuuskopiointi
- Nimi: Natalia Ríos, BA
- Puhelinnumero: +56978783002
- Sähköposti: nmrios@miuandes.cl
Opiskelupaikat
-
-
-
Santiago, Chile
- Rekrytointi
- Universidad De Los Andes
-
Päätutkija:
- Jorge Gaete, PhD
-
Alatutkija:
- Daniela Valenzuela, MSc
-
Alatutkija:
- Ricardo Araya, PhD
-
Ottaa yhteyttä:
- Jorge Gaete, PhD
- Puhelinnumero: +56226182277
- Sähköposti: jgaete@uandes.cl
-
Ottaa yhteyttä:
- Constanza Inzunza, BA
- Puhelinnumero: +56987104930
- Sähköposti: cminzunza@miuandes.cl
-
Alatutkija:
- Marcela Cárcamo, MSc
-
Alatutkija:
- Cristian Rojas, PhD
-
Alatutkija:
- Roger Weissberg, PhD
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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).
|
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.
Muut nimet:
|
|
Ei väliintuloa: Control Group
The control schools will continue providing their traditional preventive actions.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Cigarette use in the last month
Aikaikkuna: Past 30-day period
|
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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Alcohol use in the last month
Aikaikkuna: Past 30-day period
|
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
|
Past 30-day period
|
|
Marijuana use in the last month
Aikaikkuna: Past 30-day period
|
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
|
Past 30-day period
|
|
Social problem-solving
Aikaikkuna: Last 3 months
|
Measured with Social Problem-Solving Inventory, short version.
This is a 25-item instrument that measures several problem-solving skills.
|
Last 3 months
|
|
Emotional regulation
Aikaikkuna: Last 3 months
|
Measured with Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA).This is a 10-item instrument that measures emotional regulation.
|
Last 3 months
|
|
Socio-emotional skills
Aikaikkuna: Last 3 months
|
Measured with Strengths and Difficulties Questionnaire (SDQ).
This is a 25-item instrument that measures emotional, conduct, peer and hyperactivity/inattention problems
|
Last 3 months
|
|
Sense of school membership
Aikaikkuna: Last 3 months
|
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.
|
Last 3 months
|
Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- FONIS SA19I0115
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .