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

Sponsors

Lead Sponsor: University of Seville

Collaborator: Delegación del Gobierno para el Plan Nacional sobre Drogas
Maastricht University

Source 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.

Overall Status Active, not recruiting
Start Date 2020-10-01
Completion Date 2022-02-28
Primary Completion Date 2021-06-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change on the prevalence of binge drinking 6 months after the baseline
Change on the prevalence of binge drinking 12 months after the baseline
Secondary Outcome
Measure Time Frame
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
Change on the prevalence of any consumption 12 months after the baseline
Enrollment 2625
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Alerta Alcohol

Description: 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).

Arm Group Label: Alerta Alcohol

Other Name: A text-based computer-tailored game intervention

Intervention Type: Behavioral

Intervention Name: Alerta Alcohol 2.0

Description: 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.

Arm Group Label: Alerta Alcohol 2.0

Other Name: An animation-based computer-tailored game intervention

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.

Gender:

All

Minimum Age:

14 Years

Maximum Age:

19 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Location
Facility: Marta Lima Serrano
Location Countries

Spain

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Seville

Investigator Full Name: Marta Lima Serrano

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Alerta Alcohol

Type: Experimental

Description: The 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.

Label: Alerta Alcohol 2.0

Type: Experimental

Description: The 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.

Label: Control condition

Type: No Intervention

Description: 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). Evaluations take place after six and twelve months from baseline.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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

Masking: None (Open Label)

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