An Animation- Versus Text-based Computer-tailored Game Intervention to Prevent Alcohol Consumption in Adolescents
ALERTA ALCOHOL: The Development and Evaluation of an Animation- Versus Text-based Computer-tailored Game Intervention to Prevent Alcohol Consumption and Binge Drinking in Adolescents
1 other identifier
interventional
2,625
1 country
1
Brief Summary
This study consists in the design, implementation and evaluation of an animation (Alerta Alcohol 2.0)- versus text-based (Alerta Alcohol) computer-tailored game intervention aimed to prevent alcohol consumption and binge drinking (BD) in Spanish adolescents. A Cluster Randomized Controlled Trial (CRCT) is conducted to test the effectiveness of Alerta Alcohol versus Alerta Alcohol 2.0 in students aged 14 to 19 years across 24 high schools from Andalusia (southern Spain), which are randomized either to the experimental (EC-1, EC-2) or the control conditions (CC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 9, 2021
CompletedFirst Posted
Study publicly available on registry
April 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedOctober 12, 2022
October 1, 2022
9 months
April 9, 2021
October 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change on the prevalence of binge drinking
Change on the prevalence of binge drinking (4/5 standard drink units or standard glasses of alcohol in one occasion for a girl/boy) within 30 days prior to evaluation.
6 months after the baseline
Change on the prevalence of binge drinking
Change on the prevalence of binge drinking (4/5 standard drink units or standard glasses of alcohol in one occasion for a girl/boy) within 30 days prior to evaluation.
12 months after the baseline
Secondary Outcomes (6)
Change on the prevalence of high-intensity drinking
6 months after the baseline
Change on the prevalence of high-intensity drinking
12 months after the baseline
Change on the average of weekly consumption
6 months after the baseline
Change on the average of weekly consumption
12 months after the baseline
Change on the prevalence of any consumption
6 months after the baseline
- +1 more secondary outcomes
Study Arms (3)
Alerta Alcohol
EXPERIMENTALThe EC-1 receives Alerta Alcohol, which consists of session 1 or baseline, two sessions in three scenarios: at home, celebrations, and public places, and two follow-up evaluations. 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. In addition, four booster sessions are given at home to reinforce the contents of the three scenarios. Evaluations take place after six and twelve months.
Alerta Alcohol 2.0
EXPERIMENTALThe EC-2 receives an improved version of Alerta Alcohol (Alerta Alcohol 2.0) using animated videos and new gamification strategies. Evaluations take place after six and twelve months.
Control condition
NO INTERVENTIONThe CC just completes the baseline and the evaluation questionnaires and then they are allowed to receive the intervention as well (as a waiting list). Evaluations take place after six and twelve months from baseline.
Interventions
The intervention consists of preventive messages about the benefits of not consuming alcohol, reducing the positive attitudes and encouraging the negative attitudes towards alcohol drinking and BD, as well as social influence and self-efficacy, by personalized feedback. Skills and action plans are encouraged to help the student to reject BD. This information is presented through different tailored text messages. Moreover, several gamification strategies are used (i.e. offering a challenge, giving different stories and the use of avatars in these stories that take place in three different scenarios: at home, at celebrations and in public places).
The intervention consists of preventive messages about the benefits of not consuming alcohol, reducing the positive attitudes and encouraging the negative attitudes towards alcohol drinking and BD, as well as social influence and self-efficacy, by personalized feedback. Skills and action plans are encouraged to help the student to reject BD. This information is presented through different animated videos. Moreover, new gamification strategies are added (i.e. giving rewards and allocating points that can be accumulated and shown in a progress ranking) to those already used in Alerta Alcohol.
Eligibility Criteria
You may qualify if:
- Students aged 14 to 19 years.
- Enrolled in Andalusian public or private high schools.
- Access to the Internet at the schools and the use of computer, mobile or tablet is allowed.
- Access to the Internet in their homes.
You may not qualify if:
- Language barriers.
- Previous participation in prevention programs for BD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sevillelead
- Delegación del Gobierno para el Plan Nacional sobre Drogascollaborator
- Maastricht Universitycollaborator
Study Sites (1)
Marta Lima Serrano
Seville, 41009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- Principal Investigator
Study Record Dates
First Submitted
April 9, 2021
First Posted
April 21, 2021
Study Start
October 1, 2020
Primary Completion
June 30, 2021
Study Completion
February 28, 2022
Last Updated
October 12, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- From 2021.
- Access Criteria
- The Access Criteria will be the one exposed by the scientific journals where the results of the study will be published.
The IPD will be shared with other researchers through publications in scientific journals and conferences/congresses.