Alcohol DrinkingNCT04853628
An Animation- Versus Text-based Computer-tailored Game Intervention to Prevent Alcohol Consumption in Adolescents
A study testing Alerta Alcohol and Alerta Alcohol 2.0 in people with Alcohol Drinking and Binge Drinking, run by University of Seville at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Binge Drinking, Adolescent Behavior
- What is being tested?
- Alerta Alcohol and Alerta Alcohol 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,625 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2020to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Language barriers.
- Previous participation in prevention programs for BD.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Alcohol Drinking, Binge Drinking, Adolescent Behavior
- Being tested
- Alerta Alcohol, Alerta Alcohol 2.0
- Keywords
- Alcohol use, Binge drinking, High-intensity drinking, Adolescents, Web-based interventions, Computer-tailoring, Animation
- Medical subject headings
- Alcohol Drinking, Binge Drinking, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alerta AlcoholBehavioural
Also called A text-based computer-tailored game intervention
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 2.0Behavioural
Also called An animation-based computer-tailored game intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Alerta Alcohol | Experimental | 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. Receives: Behavioral: Alerta Alcohol |
| Alerta Alcohol 2.0 | Experimental | 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. Receives: Behavioral: Alerta Alcohol 2.0 |
| Control condition | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the prevalence of binge drinking
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.
Measured: 6 months after the baseline
Change on the prevalence of binge drinking
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.
Measured: 12 months after the baseline
Secondary outcomes (6)
Change on the prevalence of high-intensity drinking
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.
Measured: 6 months after the baseline
Change on the prevalence of high-intensity drinking
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.
Measured: 12 months after the baseline
Change on the average of weekly consumption
Change on the average of the total number of glasses consumed within the 7 days prior to evaluation.
Measured: 6 months after the baseline
Change on the average of weekly consumption
Change on the average of the total number of glasses consumed within the 7 days prior to evaluation.
Measured: 12 months after the baseline
Change on the prevalence of any consumption
Change on the prevalence of any consumption
Measured: 6 months after the baseline
Change on the prevalence of any consumption
Change on the prevalence of any consumption
Measured: 12 months after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Oct 2020
- Primary completion30 Jun 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 2,625 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Delegación del Gobierno para el Plan Nacional sobre Drogas, Maastricht University
- Responsible party
- Principal investigator, Marta Lima Serrano, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853628
- Sponsor's protocol ID
- University of Seville (Spain)
- Status last verified
- Oct 2022
- First submitted
- 9 Apr 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be shared with other researchers through publications in scientific journals and conferences/congresses.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04853628
- Acronym / sponsor ID
- University of Seville (Spain)
- Conditions
- Alcohol Drinking, Binge Drinking, Adolescent Behavior
- Keywords
- Alcohol use, Binge drinking, High-intensity drinking, Adolescents, Web-based interventions, Computer-tailoring, Animation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,625 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Delegación del Gobierno para el Plan Nacional sobre Drogas, Maastricht University
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alerta Alcohol | Experimental | Behavioral: Alerta AlcoholThe 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. |
| Alerta Alcohol 2.0 | Experimental | Behavioral: Alerta Alcohol 2.0The 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. |
| Control condition | No intervention | –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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Language barriers.
- Previous participation in prevention programs for BD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alerta AlcoholAlso: A text-based computer-tailored game interventionThe 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). | Behavioural | Alerta Alcohol |
| Alerta Alcohol 2.0Also: An animation-based computer-tailored game interventionThe 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. | Behavioural | Alerta Alcohol 2.0 |
Primary outcome
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.
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.
6 secondary outcomes
Change on the prevalence of high-intensity drinking
Time frame: 6 months after the baseline
Change on the prevalence of high-intensity drinking
Time frame: 12 months after the baseline
Change on the average of weekly consumption
Time frame: 6 months after the baseline
Change on the average of weekly consumption
Time frame: 12 months after the baseline
Change on the prevalence of any consumption
Time frame: 6 months after the baseline
Change on the prevalence of any consumption
Time frame: 12 months after the baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: Yes. The IPD will be shared with other researchers through publications in scientific journals and conferences/congresses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alerta Alcohol and Alerta Alcohol 2.0 in people with Alcohol Drinking and Binge Drinking, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on the prevalence of binge drinking (time frame: 6 months after the baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.