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

2022年3月18日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (予想される)

600

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Jorge Gaete, PhD
  • 電話番号：+56226182277
  • メール：jgaete@uandes.cl

研究連絡先のバックアップ

研究場所

  • チリ
      • Santiago、チリ
        • 募集
        • Universidad de Los Andes
        • 主任研究者：
          • Jorge Gaete, PhD
        • 副調査官：
          • Daniela Valenzuela, MSc
        • 副調査官：
          • Ricardo Araya, PhD
        • コンタクト：
        • コンタクト：
        • 副調査官：
          • Marcela Cárcamo, MSc
        • 副調査官：
          • Cristian Rojas, PhD
        • 副調査官：
          • Roger Weissberg, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

9年～13年 (子)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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).
行動：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.
他の名前：
  • Social Competence Promotion Program for Young Adolescents
  • New Haven Program
  • Mi Mejor Plan
介入なし：Control Group
The control schools will continue providing their traditional preventive actions.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Cigarette use in the last month
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Alcohol use in the last month
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Universidad de los Andes, Chile

協力者

Comisión Nacional de Investigación Científica y Tecnológica
University of Talca

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年3月1日

一次修了 (予想される)

2022年12月30日

研究の完了 (予想される)

2023年5月30日

試験登録日

最初に提出

2020年1月17日

QC基準を満たした最初の提出物

2020年1月17日

最初の投稿 (実際)

2020年1月22日

学習記録の更新

投稿された最後の更新 (実際)

2022年4月1日

QC基準を満たした最後の更新が送信されました

2022年3月18日

最終確認日

2022年3月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • FONIS SA19I0115

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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