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临床试验/NCT05630157
NCT05630157尚未招募不适用

Evaluation of Effectiveness of the School-based Substance Use Prevention Program "Unplugged" on Gambling Behaviors Among Adolescents: an Experimental Controlled Study

Università degli Studi del Piemonte Orientale "Amedeo Avogadro"0 个研究点目标入组 3,046 人开始时间: 2022年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
3,046
主要终点
Prevalence of gambling behaviors

研究概览

简要总结

The main aim of this study is to assess the effectiveness of a new component on gambling prevention to be added to the evidence-based school based prevention curriculum "Unplugged". The evaluation of effectiveness will be performed by conducting a non-randomized cluster controlled trial in classes of pupils 12 to 14 years old. Classes will be allocated to the intervention arm (receving Unplugged + the gambling component) or to the control arm (usual curriculum, no specific intervention).

The intervention includes 12 prevention units and a 13th unit focused on gambling. It will be carried out by Unplugged teachers trained in a specific training course. Data collection will take place before and after the intervention through a standardized questionnaire developed ad hoc and containing previously validated questions.

详细描述

The goals of the present non-randomized cluster controlled experimental trial (CCT) with follow-up at 4-8 weeks after the end of the intervention are:

  1. to assess the effectiveness of a gambling-focused component added to the Unplugged prevention curriculum on: gambling behaviors, knowledge, attitudes, risk perceptions, beliefs, refusal skills, and normative perceptions;
  2. to estimate the prevalence of gambling behaviors among Italian adolescents aged 12 to 14 years.

Unplugged is a school-based curriculum aimed to prevent tobacco, alcohol and drugs use among adolescents, developed and tested in the EUDap trial (www.eudap.net). It was demonstrated to be effective in several studies (Faggiano 2007; 2008; 2010; Gabrhelik 2012; Sanchez 2021; Vigna-Taglianti 2021) and included among evidence-based prevention programs (EMCDDA; Foxcroft 2011; Catalano 2012).

Secondary schools in Lazio, Piedmont and other Italian regions will be invited to take part in the study. Participation is voluntary for both the intervention and the control group. The schools participating in the study will inform caregivers and ask their consent for the participationof students and the data collection. Only students whose caregivers have given consent to participate will be involved in the study which will last about 7 months. The first questionnaire will be administered between November and December 2022 both in the control and the intervention group. Afterwards, the intervention group will received the 12 units of the Unplugged program and the gambling component, for about 3 months. Finally, after 4 to 8 weeks from the completion of the program, the same evaluation questionnaire will be administeres both in the control and in the intervention classes.

The questionnaire will be anonymous and will report only a pseudo-anonymization code for linkage of baseline and follow-up data. At the end of the survey, data will be analyzed in aggregated and anonymized form.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Schools/classes in which at least one teacher has participated in the training course for Unplugged teachers, either in the past or in the weeks before the beginning of the study.
  • Participation of already trained teachers in a booster training session on the gambling component.

排除标准

  • classes which already started the Unplugged program in fall 2022, before the start of the study.
  • pupils whose caregivers expressed refusal to participate in the study.

结局指标

主要结局

Prevalence of gambling behaviors

时间窗: follow-up (4-8 weeks after completion of intervention)

past 30 days frequency of gambling behaviors

次要结局

  • Refusal skills for gambling(follow-up (4-8 weeks after completion of intervention))
  • Prevalence of at-risk gambling behavior(follow-up (4-8 weeks after completion of intervention))
  • Normative perceptions on gambling(follow-up (4-8 weeks after completion of intervention))
  • Risk perceptions on gambling(follow-up (4-8 weeks after completion of intervention))
  • Beliefs about gambling(follow-up (4-8 weeks after completion of intervention))
  • Attitudes towards gambling(follow-up (4-8 weeks after completion of intervention))

研究者

发起方
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federica Vigna Taglianti

professor

Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

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