- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05849636
Alerta Cannabis: Evaluation of Web-based Tailored Intervention (NOTCANNABIS)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marta Lima Serrano, PhD
- Phone Number: +34651330654
- Email: mlima@us.es
Study Locations
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Sevilla, Spain, 41009
- Recruiting
- University of Sevilla
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Contact:
- Oficina de Proyectos Estatales y Autonómicos (OPEA)
- Phone Number: +34 954486791
- Email: opea@us.es
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Contact:
- Phone Number: +34 651330654
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Principal Investigator:
- Marta Lima Serrano, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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).
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cannabis use lifetime
Time Frame: six months after the baseline
|
cannabis use lifetime
|
six months after the baseline
|
cannabis use lifetime
Time Frame: twelve months after the baseline
|
cannabis use lifetime
|
twelve months after the baseline
|
cannabis use last 6 months (long-term)
Time Frame: six months after the baseline
|
cannabis use lifetime
|
six months after the baseline
|
cannabis use last 6 months (long-term)
Time Frame: twelve months after the baseline
|
cannabis use lifetime
|
twelve months after the baseline
|
cannabis use last 30 days (recent use)
Time Frame: six months after the baseline
|
cannabis use last 30 days (recent use)
|
six months after the baseline
|
cannabis use last 30 days (recent use)
Time Frame: twelve months after the baseline
|
cannabis use last 30 days (recent use)
|
twelve months after the baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intention to use cannabis
Time Frame: six months after the baseline
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Intention to use cannabis in the future
|
six months after the baseline
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Intention to use cannabis
Time Frame: twelve months after the baseline
|
Intention to use cannabis in the future
|
twelve months after the baseline
|
Intention to change cannabis consumption
Time Frame: six months after the baseline
|
Intention to change cannabis consumption
|
six months after the baseline
|
Intention to change cannabis consumption
Time Frame: twelve months after the baseline
|
Intention to change cannabis consumption
|
twelve months after the baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marta Lima Serrano, University of Seville
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PID2019-107229RA-I00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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