NOTCANNABIS: Alerta Cannabis: Evaluation of Web-based Tailored Intervention

Sponsor

University of Seville (Other)

Overall Status

Recruiting

CT.gov ID

NCT05849636

Collaborator

Ministerio de Ciencia, Innovación y Universidades (Other), Maastricht University (Other)

1,850

Enrollment

Location

Arms

Anticipated Duration (Months)

115.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Cannabis Use Adolescent Behavior E-health	Behavioral: ALERTA CANNABIS	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1850 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A Cluster Randomized Controlled Trial is conducted to test the effectiveness of ALERTA CANNABIS in students aged 14 to 18 years. The study Will be carried out in 34 high schools from Andalusia (southern Spain), which will be randomized either to the experimental or the control condition (EC and CC). The EC will receive the ALERTA CANNABIS intervention, which consists of four sessions at school.The CC just completes the baseline and the evaluation questionnaires.A Cluster Randomized Controlled Trial is conducted to test the effectiveness of ALERTA CANNABIS in students aged 14 to 18 years. The study Will be carried out in 34 high schools from Andalusia (southern Spain), which will be randomized either to the experimental or the control condition (EC and CC). The EC will receive the ALERTA CANNABIS intervention, which consists of four sessions at school.The CC just completes the baseline and the evaluation questionnaires.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ALERTA CANNABIS 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.	Behavioral: ALERTA CANNABIS The intervention consists of preventive messages about the benefits of not consuming cannabis, reducing the positive attitudes and encouraging the negative attitudes towards cannabis use, as well as social influence and self-efficacy, by personalized feedback. Skills and action plans are encouraged to help the student to reject cannabis use. This information is presented through different tailored messages. In addition, the participants will be able to choose avatars to accompany them during the intervention. The intervention consists of a short story about the cannabis use by adolescents.The stories take place in three different scenarios (at home, at school leaving, and in public places).
No Intervention: CONTROL Control Group: The Control Group just completes the baseline and the evaluation questionnaires. Evaluation takes place after six and twelve months from baseline

Arm

Intervention/Treatment

Experimental: ALERTA CANNABIS

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.

Behavioral: ALERTA CANNABIS

The intervention consists of preventive messages about the benefits of not consuming cannabis, reducing the positive attitudes and encouraging the negative attitudes towards cannabis use, as well as social influence and self-efficacy, by personalized feedback. Skills and action plans are encouraged to help the student to reject cannabis use. This information is presented through different tailored messages. In addition, the participants will be able to choose avatars to accompany them during the intervention. The intervention consists of a short story about the cannabis use by adolescents.The stories take place in three different scenarios (at home, at school leaving, and in public places).

No Intervention: CONTROL

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

Outcome Measures

Primary Outcome Measures

cannabis use lifetime [six months after the baseline]
cannabis use lifetime
cannabis use lifetime [twelve months after the baseline]
cannabis use lifetime
cannabis use last 6 months (long-term) [six months after the baseline]
cannabis use lifetime
cannabis use last 6 months (long-term) [twelve months after the baseline]
cannabis use lifetime
cannabis use last 30 days (recent use) [six months after the baseline]
cannabis use last 30 days (recent use)
cannabis use last 30 days (recent use) [twelve months after the baseline]
cannabis use last 30 days (recent use)

Secondary Outcome Measures

Intention to use cannabis [six months after the baseline]
Intention to use cannabis in the future
Intention to use cannabis [twelve months after the baseline]
Intention to use cannabis in the future
Intention to change cannabis consumption [six months after the baseline]
Intention to change cannabis consumption
Intention to change cannabis consumption [twelve months after the baseline]
Intention to change cannabis consumption

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.