An Animation- Versus Text-based Computer-tailored Game Intervention to Prevent Alcohol Consumption in Adolescents

Not Applicable

Completed

• Conditions: Binge Drinking; Alcohol Drinking; Adolescent Behavior

• Registration Number: NCT04853628
• Lead Sponsor: University of Seville

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).

Detailed Description

Alcohol use and misuse, and particularly, BD in adolescents are a highly prevalent healthcare problem that associates physical and mental health complications and community implications. The Alerta Alcohol and Alerta Alcohol 2.0 programs are based on the I-Change Model. A CRCT is carried out. The schools from Andalusia are randomized either to the experimental (EC-1, EC-2) or the control conditions (CC). The EC-1 receives an online intervention (Alerta Alcohol, which has adapted from a previous version) with personalized health advice, using textual feedback and several gamification techniques, and consists of nine sessions (performing seven of them at the high school): session 1 or baseline, sessions 2 and 3 where adolescents are provided with answers related to their views to provide highly specific feedback regarding their knowledge, risk perception, self-esteem, attitude, social influence and self-efficacy; sessions 4, 5, 7 and 8 are reinforcement sessions (booster sessions) and sessions 6 and 9 are follow-up questionnaires at six and twelve months. The EC-2 receives an improved version of Alerta Alcohol (Alerta Alcohol 2.0) using animated videos and new gamification strategies. The CC just completes the baseline and the evaluation questionnaires and then they are allowed to receive the intervention as well (as a waiting list). To test the effectiveness, the primary outcome is BD within 30 days prior to evaluation and alcohol use (high-intensity drinking, weekly and any consumption) in the previous week as secondary outcomes.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-21
• Primary Completion: 2021-06-30
• Study Completion: 2022-02-28
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-09
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2625

Inclusion Criteria

• 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.

Exclusion Criteria

• Language barriers.
• Previous participation in prevention programs for BD.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change on the prevalence of binge drinking	12 months after the baseline	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.

Secondary Outcome Measures

Name	Time	Method
Change on the prevalence of high-intensity drinking	12 months after the baseline	Change on the prevalence of high-intensity drinking (8/10 standard drink units or standard glasses of alcohol in one occasion for a girl/boy) within the 7 days prior to evaluation.
Change on the average of weekly consumption	12 months after the baseline	Change on the average of the total number of glasses consumed within the 7 days prior to evaluation.
Change on the prevalence of any consumption	12 months after the baseline	Change on the prevalence of any consumption

Trial Locations

Locations (1)

Marta Lima Serrano; 🇪🇸 Sevilla, Spain