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Alerta Cannabis: Evaluation of Web-based Tailored Intervention (NOTCANNABIS)

Primary Purpose

Cannabis Use, Adolescent Behavior, E-health

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ALERTA CANNABIS
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cannabis Use focused on measuring adolescence, cannabis use, i-change model, web-based interventions, e-health, prevention

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of SevillaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ALERTA CANNABIS

CONTROL

Arm Description

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.

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

Outcomes

Primary Outcome Measures

cannabis use lifetime
cannabis use lifetime
cannabis use lifetime
cannabis use lifetime
cannabis use last 6 months (long-term)
cannabis use lifetime
cannabis use last 6 months (long-term)
cannabis use lifetime
cannabis use last 30 days (recent use)
cannabis use last 30 days (recent use)
cannabis use last 30 days (recent use)
cannabis use last 30 days (recent use)

Secondary Outcome Measures

Intention to use cannabis
Intention to use cannabis in the future
Intention to use cannabis
Intention to use cannabis in the future
Intention to change cannabis consumption
Intention to change cannabis consumption
Intention to change cannabis consumption
Intention to change cannabis consumption

Full Information

First Posted
March 16, 2023
Last Updated
April 27, 2023
Sponsor
University of Seville
Collaborators
Ministerio de Ciencia, Innovación y Universidades, Maastricht University
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1. Study Identification

Unique Protocol Identification Number
NCT05849636
Brief Title
Alerta Cannabis: Evaluation of Web-based Tailored Intervention
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
Collaborators
Ministerio de Ciencia, Innovación y Universidades, Maastricht University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use, Adolescent Behavior, E-health
Keywords
adolescence, cannabis use, i-change model, web-based interventions, e-health, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
1850 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ALERTA CANNABIS
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
Control Group: The Control Group just completes the baseline and the evaluation questionnaires. Evaluation takes place after six and twelve months from baseline
Intervention Type
Behavioral
Intervention Name(s)
ALERTA CANNABIS
Intervention Description
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).
Primary Outcome Measure Information:
Title
cannabis use lifetime
Description
cannabis use lifetime
Time Frame
six months after the baseline
Title
cannabis use lifetime
Description
cannabis use lifetime
Time Frame
twelve months after the baseline
Title
cannabis use last 6 months (long-term)
Description
cannabis use lifetime
Time Frame
six months after the baseline
Title
cannabis use last 6 months (long-term)
Description
cannabis use lifetime
Time Frame
twelve months after the baseline
Title
cannabis use last 30 days (recent use)
Description
cannabis use last 30 days (recent use)
Time Frame
six months after the baseline
Title
cannabis use last 30 days (recent use)
Description
cannabis use last 30 days (recent use)
Time Frame
twelve months after the baseline
Secondary Outcome Measure Information:
Title
Intention to use cannabis
Description
Intention to use cannabis in the future
Time Frame
six months after the baseline
Title
Intention to use cannabis
Description
Intention to use cannabis in the future
Time Frame
twelve months after the baseline
Title
Intention to change cannabis consumption
Description
Intention to change cannabis consumption
Time Frame
six months after the baseline
Title
Intention to change cannabis consumption
Description
Intention to change cannabis consumption
Time Frame
twelve months after the baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Lima Serrano, PhD
Phone
+34651330654
Email
mlima@us.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Lima Serrano
Organizational Affiliation
University of Seville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sevilla
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oficina de Proyectos Estatales y Autonómicos (OPEA)
Phone
+34 954486791
Email
opea@us.es
Phone
+34 651330654
First Name & Middle Initial & Last Name & Degree
Marta Lima Serrano, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Alerta Cannabis: Evaluation of Web-based Tailored Intervention

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