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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2625 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Guided Self-Change Prevention Program for Alcohol Abuse in Adolescents in Educational Settings

NCT05281172

Alcohol Abuse or Dependence

COMPLETED NA

Promoting Alcohol-related Attitudinal and Behavioural Change Amongst Adolescents Through Internet Intervention

NCT02450344

Health Knowledge, Attitudes, Practice Drinking Behaviour

COMPLETED NA

Effectiveness of an Intervention in Patients With Excessive Alcohol Consumption

NCT04811729

Alcohol Consumption Alcohol Use Disorder

COMPLETED NA

Testing Brief Personalized Feedback Integrating EMA Alcohol Cue Information

NCT05373706

Alcohol Drinking Problem Drinking

COMPLETED NA

Impact of Marketing of Alcohol Products on Young People

NCT03818750

Alcoholism

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Drinking Binge Drinking Adolescent Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Alerta Alcohol

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.

Group Type EXPERIMENTAL

Alerta Alcohol

Intervention Type 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).

Alerta Alcohol 2.0

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.

Group Type EXPERIMENTAL

Alerta Alcohol 2.0

Intervention Type 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.

Control condition

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alerta Alcohol

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).

Intervention Type BEHAVIORAL

Alerta Alcohol 2.0

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

A text-based computer-tailored game intervention An animation-based computer-tailored game intervention

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.