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临床试验/NCT05849636
NCT05849636招募中不适用

Alerta Cannabis: Evaluación de Una Intervención a Medida Basada en el Ordenador Para la Prevención Del Consumo de Cannabis en Adolescentes de 14 a 18 Años

University of Seville1 个研究点 分布在 1 个国家目标入组 1,850 人开始时间: 2022年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,850
试验地点
1
主要终点
cannabis use last 30 days (recent use)

研究概览

简要总结

This study consists in the the design, implementation, and evaluation of the first web-based computer tailored intervention program aimed at the prevention of cannabis use in Spanish adolescents (ALERTA CANNABIS). A Cluster Randomized Controlled Trial is conducted to test the effectiveness of ALERTA CANNABIS in students aged 14 to 18 years across 34 high schools from Andalusia (southern Spain), which are randomized either to the experimental or the control condition (EC and CC).

详细描述

Cannabis is the third most widespread drug and the most widely used illegal drug in Spanish and Andalusian adolescents aged 14 to 18 years, representing 8 out of 10 admissions to treatment for drug dependency in minors. It is necessary to continue investing in research applied to the prevention of cannabis consumption in order to develop scientifically validated strategies that can become preventive policies. The objective of the project is to contribute to the prevention of cannabis use in children, through the development, implementation and evaluation of the cost-effectiveness of a web-based-computer-tailoring and gamified learning intervention, having as reference the integrated theoretical model on adoption of health behaviors, the I-Change model. The starting hypothesis is that the application of this program, ALERTA CANNABIS, to children from 14 to 18 years old at the school context, will be cost-effective for reducing the prevalence of cannabis use.

A cluster randomized controlled trial will be carried out, with an intervention group, which will receive the ALERTA CANNABIS intervention and a waiting list control group. The following phases will be followed: design, implementation, cost-effectiveness evaluation (at 6 and 12 months), and dissemination of results.

ALERT CANNABIS will carry out an individualized advice, by means of pre-established messages, but generated based on the characteristics detected in a questionnaire (for example, the user's first name and taking into account the gender perspective, different types of reinforcement, etc.). In addition, it will use gamification techniques (videos, incentives, rankings) to encourage motivation and adherence to the intervention. The intervention will address motivational factors associated of cannabis use such as attitude, social influences, self-efficacy and intention.

The sample will consist of 1850 Andalusian students aged 14 to 18 enrolled in public high schools of the Andalusian provinces of Seville, Cordoba, Huelva, Cádiz, Granada and Malaga, 37 class groups by condition for the cluster design. Both, for the initial study and for the evaluation of cost-effectiveness, an online questionnaire applied in the school context will be used, with the variables resulting from the prevalence of cannabis use (in life, in the last 6 months, in last month), cannabis abuse using the cannabis abuse screening test (CAST) and health-related quality of life in terms of quality-adjusted life years (QALY). Confidentiality will be ensured in accordance with Royal Decree-Law 5/2018, of July 27, on the Protection of Personal Data. Informed consent will be requested.

If the cost-effectiveness of the program is demonstrated, it can be disseminated by becoming a public health policy.

研究设计

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

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Criteria: Inclusion Criteria:
  • •Students aged 14 to 18 years.
  • •Enrolled in Andalusian public high schools.
  • •Access to the Internet at the school and an equipped information and communication technology (ICT) room.

排除标准

  • •Language barriers.
  • •Previous participation in prevention programs for cannabis use.

研究组 & 干预措施

ALERTA CANNABIS

Experimental

The Experimental Group receives the ALERTA CANNABIS intervention, which consists of four sessions at school (baseline questionnaire, two sessions in three scenarios: at home, celebrations, and public places, and a final evaluation). The adolescents are provided with answers related to their views of each scenario; this information is used to provide highly specific feedback regarding their knowledge, risk perception, self-esteem, attitude, social influence (modelling, norms and social pressure), self-efficacy and action plans. The post-tests will be carried out at six and twelve months from the baseline.

干预措施: ALERTA CANNABIS (Behavioral)

CONTROL

No Intervention

Control Group: The Control Group just completes the baseline and the evaluation questionnaires. Evaluation takes place after six and twelve months from baseline

结局指标

主要结局

cannabis use last 30 days (recent use)

时间窗: twelve months after the baseline

cannabis use last 30 days (recent use)

cannabis use lifetime

时间窗: twelve months after the baseline

cannabis use lifetime

cannabis use last 6 months (long-term)

时间窗: twelve months after the baseline

cannabis use lifetime

cannabis use lifetime

时间窗: six months after the baseline

cannabis use lifetime

cannabis use last 6 months (long-term)

时间窗: six months after the baseline

cannabis use lifetime

cannabis use last 30 days (recent use)

时间窗: six months after the baseline

cannabis use last 30 days (recent use)

次要结局

  • Intention to use cannabis(twelve months after the baseline)
  • Intention to change cannabis consumption(twelve months after the baseline)
  • Intention to use cannabis(six months after the baseline)
  • Intention to change cannabis consumption(six months after the baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marta Lima-Serrano, PhD

Associate Professor

University of Seville

研究点 (1)

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