Alerta Cannabis: Evaluation of Web-based Tailored Intervention

Adolescent Behavior Clinical Trial

— NOTCANNABIS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849636
• Other study ID #: PID2019-107229RA-I00
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: April 2023
• Source: University of Seville
• Contact: Marta Lima Serrano, PhD
• Phone: +34651330654
• Email: mlima[@]us.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1850
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Cannabis Use
• Marijuana Abuse

Intervention

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).

Locations

Country	Name	City	State
Spain	University of Sevilla	Sevilla

Sponsors (3)

Lead Sponsor	Collaborator
University of Seville	Maastricht University, Ministerio de Ciencia, Innovación y Universidades

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cannabis use lifetime	cannabis use lifetime	six months after the baseline
Primary	cannabis use lifetime	cannabis use lifetime	twelve months after the baseline
Primary	cannabis use last 6 months (long-term)	cannabis use lifetime	six months after the baseline
Primary	cannabis use last 6 months (long-term)	cannabis use lifetime	twelve months after the baseline
Primary	cannabis use last 30 days (recent use)	cannabis use last 30 days (recent use)	six months after the baseline
Primary	cannabis use last 30 days (recent use)	cannabis use last 30 days (recent use)	twelve months after the baseline
Secondary	Intention to use cannabis	Intention to use cannabis in the future	six months after the baseline
Secondary	Intention to use cannabis	Intention to use cannabis in the future	twelve months after the baseline
Secondary	Intention to change cannabis consumption	Intention to change cannabis consumption	six months after the baseline
Secondary	Intention to change cannabis consumption	Intention to change cannabis consumption	twelve months after the baseline