Clinical trial NCT05849636: Alerta Cannabis: Evaluation of Web-based Tailored Intervention
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cannabis Use
Adolescent Behavior
E-health
Keywords: adolescence
cannabis use
i-change model
web-based interventions
e-health
prevention
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: Ministerio de Ciencia, Innovación y Universidades
name: Maastricht University
First posted: 2023-05-09
Enrollment: 1850
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: cannabis use lifetime
timeFrame: six months after the baseline
measure: cannabis use lifetime
timeFrame: twelve months after the baseline
measure: cannabis use last 6 months (long-term)
timeFrame: six months after the baseline
measure: cannabis use last 6 months (long-term)
timeFrame: twelve months after the baseline
measure: cannabis use last 30 days (recent use)
timeFrame: six months after the baseline
measure: cannabis use last 30 days (recent use)
timeFrame: twelve months after the baseline
Secondary outcomes:
measure: Intention to use cannabis
timeFrame: six months after the baseline
measure: Intention to use cannabis
timeFrame: twelve months after the baseline
measure: Intention to change cannabis consumption
timeFrame: six months after the baseline
measure: Intention to change cannabis consumption
timeFrame: twelve months after the baseline
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: University of Sevilla
Study officials:
affiliation: University of Seville
name: Marta Lima Serrano
role: PRINCIPAL_INVESTIGATOR
References: