Alerta Cannabis: Evaluation of Web-based Tailored Intervention

NCT ID: NCT05849636

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cannabis Use Adolescent Behavior E-health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

ALERTA CANNABIS

Intervention Type BEHAVIORAL

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).

CONTROL

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministerio de Ciencia, Innovación y Universidades

UNKNOWN

Sponsor Role collaborator

Maastricht University

OTHER

Sponsor Role collaborator

University of Seville

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marta Lima-Serrano, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marta Lima Serrano

Role: PRINCIPAL_INVESTIGATOR

University of Seville

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Sevilla

Seville, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marta Lima Serrano, PhD

Role: CONTACT

+34651330654

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Oficina de Proyectos Estatales y Autonómicos (OPEA)

Role: primary

+34 954486791

Role: backup

+34 651330654

References

Explore related publications, articles, or registry entries linked to this study.

Lima-Serrano M, Barrera-Villalba C, Mac-Fadden I, Mesters I, de Vries H. Alerta Cannabis: A Tailored-Computer Web-Based Program for the Prevention of Cannabis Use in Adolescents: A Cluster-Randomized Controlled Trial Protocol. BMC Nurs. 2024 Apr 10;23(1):239. doi: 10.1186/s12912-024-01889-x.

Reference Type DERIVED
PMID: 38600496 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PID2019-107229RA-I00

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Joint Effort Study
NCT05099016 COMPLETED NA
A Brief Intervention for Cannabis Use
NCT06395389 RECRUITING NA
Marijuana Treatment Project - 3
NCT00107588 COMPLETED NA
The Teen Marijuana Check-Up
NCT00350285 COMPLETED PHASE2
Teen Marijuana Check-Up
NCT01109563 COMPLETED PHASE3