Alerta Cannabis: Evaluation of Web-based Tailored Intervention

NCT05849636 | Unknown

• 1 other identifier: PID2019-107229RA-I00
• Study Type: interventional
• Target: 1,850
• Locations: 1 country
• Sites: 1

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).

Conditions

Cannabis Use; Adolescent Behavior; E-health

Keywords

adolescence; cannabis use; i-change model; web-based interventions; e-health; prevention

Outcome Measures

Primary Outcomes (6)

• cannabis use lifetime

  cannabis use lifetime

  six months after the baseline

• cannabis use lifetime

  cannabis use lifetime

  twelve months after the baseline

• cannabis use last 6 months (long-term)

  cannabis use lifetime

  six months after the baseline

• cannabis use last 6 months (long-term)

  cannabis use lifetime

  twelve months after the baseline

• cannabis use last 30 days (recent use)

  cannabis use last 30 days (recent use)

  six months after the baseline

• cannabis use last 30 days (recent use)

  cannabis use last 30 days (recent use)

  twelve months after the baseline

Secondary Outcomes (4)

• Intention to use cannabis

  six months after the baseline

• Intention to use cannabis

  twelve months after the baseline

• Intention to change cannabis consumption

  six months after the baseline

• Intention to change cannabis consumption

  twelve months after the baseline

Study Arms (2)

ALERTA CANNABIS

EXPERIMENTAL

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.

Behavioral: ALERTA CANNABIS

CONTROL

NO INTERVENTION

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

Interventions

ALERTA CANNABIS 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).

ALERTA CANNABIS

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Seville: lead
• Ministerio de Ciencia, Innovación y Universidades: collaborator
• Maastricht University: collaborator

Study Sites (1)

University of Sevilla

Seville, 41009, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 38600496 DERIVED

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Marta Lima Serrano

  University of Seville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Lima Serrano, PhD

CONTACT

+34651330654; mlima@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: May 9, 2023
• Study Start: October 1, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)