Clinical trial NCT04853628: An Animation- Versus Text-based Computer-tailored Game Intervention to Prevent Alcohol Consumption in Adolescents
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Binge Drinking
Adolescent Behavior
Keywords: Alcohol use
Binge drinking
High-intensity drinking
Adolescents
Web-based interventions
Computer-tailoring
Animation
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: Delegación del Gobierno para el Plan Nacional sobre Drogas
name: Maastricht University
First posted: 2021-04-21
Enrollment: 2625
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is performed in 24 high schools from Andalusia (southern Spain), which are randomized either to the experimental (EC-1, EC-2) or the control conditions (CC). The EC-1 receives Alerta Alcohol, 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 Alerta Alcohol 2.0, using animated videos and new gamification strategies. The CC just completes the baseline and the evaluation questionnaires.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change on the prevalence of binge drinking
timeFrame: 6 months after the baseline
measure: Change on the prevalence of binge drinking
timeFrame: 12 months after the baseline
Secondary outcomes:
measure: Change on the prevalence of high-intensity drinking
timeFrame: 6 months after the baseline
measure: Change on the prevalence of high-intensity drinking
timeFrame: 12 months after the baseline
measure: Change on the average of weekly consumption
timeFrame: 6 months after the baseline
measure: Change on the average of weekly consumption
timeFrame: 12 months after the baseline
measure: Change on the prevalence of any consumption
timeFrame: 6 months after the baseline
measure: Change on the prevalence of any consumption
timeFrame: 12 months after the baseline
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Marta Lima Serrano
Study officials:
References: