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Cannabis UseNOTCANNABISNCT05849636

Alerta Cannabis: Evaluation of Web-based Tailored Intervention

A study testing ALERTA CANNABIS in people with Cannabis Use and Adolescent Behavior, run by University of Seville at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 14 to 18 years
Conditions the study is for
Cannabis Use, Adolescent Behavior, E-health
What is being tested?
ALERTA CANNABIS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,850 participants
Where
1 siteSpain
Study dates
1 Oct 2022to 31 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Marta Lima Serrano, PhD contact

+34651330654

mlima@us.es

Spain1 site, 1 recruiting

  • University of Sevilla

    Seville, 41009

    Oficina de Proyectos Estatales y Autonómicos (OPEA), +34 954486791, opea@us.es

    +34 651330654

    Recruiting

Other trials in Spain

About this study

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

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).

Read the 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.

Being tested
ALERTA CANNABIS
Keywords
adolescence, cannabis use, i-change model, web-based interventions, e-health, prevention
Medical subject headings
Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALERTA CANNABISBehavioural

    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).

Study groups in NCT05849636
Study groupRoleWhat they receive
ALERTA CANNABISExperimentalThe 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.
Receives: Behavioral: ALERTA CANNABIS
CONTROLNo interventionControl Group: The Control Group just completes the baseline and the evaluation questionnaires. Evaluation takes place after six and twelve months from baseline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cannabis use lifetime

    cannabis use lifetime

    Measured: six months after the baseline

  2. cannabis use lifetime

    cannabis use lifetime

    Measured: twelve months after the baseline

  3. cannabis use last 6 months (long-term)

    cannabis use lifetime

    Measured: six months after the baseline

  4. cannabis use last 6 months (long-term)

    cannabis use lifetime

    Measured: twelve months after the baseline

  5. cannabis use last 30 days (recent use)

    cannabis use last 30 days (recent use)

    Measured: six months after the baseline

  6. cannabis use last 30 days (recent use)

    cannabis use last 30 days (recent use)

    Measured: twelve months after the baseline

Secondary outcomes (4)

  1. Intention to use cannabis

    Intention to use cannabis in the future

    Measured: six months after the baseline

  2. Intention to use cannabis

    Intention to use cannabis in the future

    Measured: twelve months after the baseline

  3. Intention to change cannabis consumption

    Intention to change cannabis consumption

    Measured: six months after the baseline

  4. Intention to change cannabis consumption

    Intention to change cannabis consumption

    Measured: twelve months after the baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2023
  2. Study start1 Oct 2022
  3. Primary completion31 Jan 2024 (estimated)
  4. Study completion31 Jan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
1,850 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05849636
Sponsor's protocol ID
PID2019-107229RA-I00
Acronym
NOTCANNABIS
Status last verified
Apr 2023
First submitted
16 Mar 2023
Last updated
9 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38600496

Questions about this trial

What is this clinical trial studying?

A study testing ALERTA CANNABIS in people with Cannabis Use and Adolescent Behavior, run by University of Seville at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marta Lima Serrano, PhD (+34651330654, mlima@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cannabis use lifetime (time frame: six months after the baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05849636, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.

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