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

18 marzo 2022 aggiornato da: Jorge Gaete, Universidad de los Andes, Chile

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

600

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Jorge Gaete, PhD
  • Numero di telefono: +56226182277
  • Email: jgaete@uandes.cl

Backup dei contatti dello studio

Luoghi di studio

  • Chile
      • Santiago, Chile
        • Reclutamento
        • Universidad De Los Andes
        • Investigatore principale:
          • Jorge Gaete, PhD
        • Sub-investigatore:
          • Daniela Valenzuela, MSc
        • Sub-investigatore:
          • Ricardo Araya, PhD
        • Contatto:
        • Contatto:
        • Sub-investigatore:
          • Marcela Cárcamo, MSc
        • Sub-investigatore:
          • Cristian Rojas, PhD
        • Sub-investigatore:
          • Roger Weissberg, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 9 anni a 13 anni (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Comportamentale: 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.
Altri nomi:
  • Social Competence Promotion Program for Young Adolescents
  • New Haven Program
  • Mi Mejor Plan
Nessun intervento: Control Group
The control schools will continue providing their traditional preventive actions.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cigarette use in the last month
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Alcohol use in the last month
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidad de los Andes, Chile

Collaboratori

Comisión Nacional de Investigación Científica y Tecnológica
University of Talca

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2022

Completamento primario (Anticipato)

30 dicembre 2022

Completamento dello studio (Anticipato)

30 maggio 2023

Date di iscrizione allo studio

Primo inviato

17 gennaio 2020

Primo inviato che soddisfa i criteri di controllo qualità

17 gennaio 2020

Primo Inserito (Effettivo)

22 gennaio 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 aprile 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 marzo 2022

Ultimo verificato

1 marzo 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FONIS SA19I0115

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

The investigators plan to share data using "UK Data Service". The investigators will never compromise participant privacy, neither schools nor students.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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