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Completed

NCT Number: NCT04853628

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

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).

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Key information

Conditions

Alcohol Drinking Adolescent Behavior Alcohol-Related Disorders Behavior Binge Drinking Chemically-Induced Disorders Drinking Behavior Mental Disorders Substance-Related Disorders

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marta Lima Serrano

Seville, 41009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alerta Alcohol

Behavioral

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).

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

Alerta Alcohol 2.0

Behavioral

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.

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

Primary outcomes

  1. Change on the prevalence of binge drinking

    Time frame: 6 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.

  2. Change on the prevalence of binge drinking

    Time frame: 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 outcomes

  1. Change on the prevalence of high-intensity drinking

    Time frame: 6 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.

  2. Change on the prevalence of high-intensity drinking

    Time frame: 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.

  3. Change on the average of weekly consumption

    Time frame: 6 months after the baseline

    Change on the average of the total number of glasses consumed within the 7 days prior to evaluation.

  4. Change on the average of weekly consumption

    Time frame: 12 months after the baseline

    Change on the average of the total number of glasses consumed within the 7 days prior to evaluation.

  5. Change on the prevalence of any consumption

    Time frame: 6 months after the baseline

    Change on the prevalence of any consumption

  6. Change on the prevalence of any consumption

    Time frame: 12 months after the baseline

    Change on the prevalence of any consumption

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Collaborators

  • Delegación del Gobierno para el Plan Nacional sobre Drogas
  • Maastricht University

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 21, 2021
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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