Alcohol DrinkingNCT03288896
Alerta Alcohol. Web-based Computer-tailored Intervention for Binge-drinking Prevention in Spanish Adolescents
A study testing Alerta Alcohol 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 the design, implementation, and evaluation of the first web-based computer tailored intervention program aimed at the prevention of binge drinking in Spanish adolescents (Alerta Alcohol). Read more about this study
- Who is it for?
- Ages 16 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Binge Drinking, Adolescent Behavior
- What is being tested?
- Alerta Alcohol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,230 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2016to 30 Jun 2017
- 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 16 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Students aged 16 to 18 years.
- Enrolled in Andalusian public high schools.
- Schools belonging to provincial capitals.
- Access to the Internet at the school and an equipped ICT room.
Who cannot join
- Language barriers.
- Previous participation in prevention programs for binge drinking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alerta Alcohol. Design, Implementation, and Evaluation of a Tailored Web-based Computer-tailored Intervention for Selective Prevention of Binge-drinking in Spanish Adolescents.
This study consists in the the design, implementation, and evaluation of the first web-based computer tailored intervention program aimed at the prevention of binge drinking in Spanish adolescents (Alerta Alcohol). A Cluster Randomized Controlled Trial is conducted to test the effectiveness of Alerta Alcohol in students aged 16 to 18 years across 16 high schools from Andalusia (southern Spain), which are randomized either to the experimental or the control condition (EC and CC).
Read the detailed description
Binge-drinking in adolescents is a highly prevalent healthcare problem that associates physical and mental health complications and community implications.
The "Alerta Alcohol" program is based on the I-Change Model. Focus and Delphi groups are used to obtain further information on items included in the program. A pilot study is conducted to identify strengths and weaknesses. A Cluster Randomized Controlled Trial is carried out. The schools from Andalusia are randomized either to the experimental or the control condition (EC and CC). The EC receives the Alerta Alcohol intervention, which consists of four sessions at school: baseline questionnaire and two sessions 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. In addition, two booster sessions are given at home to reinforce the contents. 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 control condition). Evaluation takes place after four months. The primary endpoint is binge drinking within 30 days prior to evaluation and alcohol use in the previous week. It is expected that Alerta Alcohol reduces the prevalence of binge drinking by 10%. Follow up analyses are carried out to determine the differences in effectiveness according to the compliance of the program (quality of the implementation).
- Conditions
- Alcohol Drinking, Binge Drinking, Adolescent Behavior
- Being tested
- Alerta Alcohol
- Keywords
- Adolescence, Alcohol Drinking, Binge Drinking, I-Change model, Web-based interventions, Computer-tailoring
- 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 Alerta Alcohol, a web-based computer-tailored 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 binge drinking, as well as social influence and self-efficacy, by personalized feedback. Skills and action plans are encouraged to help the student to reject binge drinking. This information is presented through different tailored messages. Moreover, four avatars (two males and two females), which can be chosen as part of the story development. This story consists of a short story about the alcohol consumption by adolescents.The stories take place in three different scenarios (at home, at celebrations and in public places).
| Study group | Role | What they receive |
|---|---|---|
| Alerta Alcohol | Experimental | Intervention Group: The Experimental Group receives the Alerta Alcohol intervention, which consists of four sessions at school (baseline questionnaire, two sessions in three scenarios: at home, celebrations, and public places, and a final evaluation). 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, two booster sessions are given at home to reinforce the contents of the three scenarios. Evaluation takes place after four months. Receives: Behavioral: Alerta Alcohol |
| Control Group | No intervention | Control Group: The Control Group just completes the baseline and the evaluation questionnaires and then they are allowed to receive the intervention as well (as a waiting list control condition). Evaluation takes place after four months from baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing binge-drinking
Reducing binge-drinking (4/5 glasses or alcohol in one ocassion for a girl/boy) within 30 days prior to evaluation.
Measured: 4 months after the baseline
Secondary outcomes (1)
Reducing weekly alcohol drinking
Reducing alcohol drinking within the 7 days prior to evaluation
Measured: 4 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 posted20 Sep 2017
- Study start1 Nov 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- A Cluster Randomized Controlled Trial is conducted to test the effectiveness of Alerta Alcohol in students aged 16 to 18 years. The study is performed in 16 high schools from Andalusia (southern Spain), which are randomized either to the experimental or the control condition (EC and CC). The EC receives the Alerta Alcohol intervention, which consists of four sessions at school. The adolescents are provided highly specific feedback regarding their knowledge, risk perception, self-esteem, attitude, social influence, and self-efficacy. In addition, two booster sessions are given at home to reinforce the contents of the three scenarios. 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 control condition).
- Masking
- None (open label)
- Enrolment
- 1,230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Junta de Andalucia, Maastricht University
- Responsible party
- Principal investigator, Marta Lima Serrano, University of Seville
- Investigators
- Marta Lima Serrano, PhD, Study director, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288896
- Sponsor's protocol ID
- University of Seville. Spain
- Status last verified
- Sep 2017
- First submitted
- 17 Sep 2017
- Last updated
- 20 Sep 2017
- 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 congresses
Publications
Vargas-Martinez AM, Lima-Serrano M, Trapero-Bertran M. Cost-effectiveness and cost-utility analyses of a web-based computer-tailored intervention for prevention of binge drinking among Spanish adolescents. Alcohol Clin Exp Res (Hoboken). 2023 Feb;47(2):319-335. doi: 10.1111/acer.14990. Epub 2023 Feb 22.
PubMed 36811462Vargas-Martinez AM, Trapero-Bertran M, Mora T, Lima-Serrano M. Social, economic and family factors associated with binge drinking in Spanish adolescents. BMC Public Health. 2020 Apr 17;20(1):519. doi: 10.1186/s12889-020-08605-9.
PubMed 32303203Martinez-Montilla JM, Mercken L, de Vries H, Candel M, Lima-Rodriguez JS, Lima-Serrano M. A Web-Based, Computer-Tailored Intervention to Reduce Alcohol Consumption and Binge Drinking Among Spanish Adolescents: Cluster Randomized Controlled Trial. J Med Internet Res. 2020 Jan 24;22(1):e15438. doi: 10.2196/15438.
PubMed 32012064Vargas-Martinez AM, Trapero-Bertran M, Lima-Serrano M, Anokye N, Pokhrel S, Mora T. Measuring the effects on quality of life and alcohol consumption of a program to reduce binge drinking in Spanish adolescents. Drug Alcohol Depend. 2019 Dec 1;205:107597. doi: 10.1016/j.drugalcdep.2019.107597. Epub 2019 Sep 30.
PubMed 31590139Lima-Serrano M, Martinez-Montilla JM, Lima-Rodriguez JS, Mercken L, de Vries H. Design, implementation and evaluation of a web-based computer-tailored intervention to prevent binge drinking in adolescents: study protocol. BMC Public Health. 2018 Apr 4;18(1):449. doi: 10.1186/s12889-018-5346-4.
PubMed 29618331
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alerta Alcohol. Design, Implementation, and Evaluation of a Tailored Web-based Computer-tailored Intervention for Selective Prevention of Binge-drinking in Spanish Adolescents.
- ClinicalTrials.gov ID
- NCT03288896
- Acronym / sponsor ID
- University of Seville. Spain
- Conditions
- Alcohol Drinking, Binge Drinking, Adolescent Behavior
- Keywords
- Adolescence, Alcohol Drinking, Binge Drinking, I-Change model, Web-based interventions, Computer-tailoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,230 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Junta de Andalucia, Maastricht University
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 20 Sep 2017 (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 the design, implementation, and evaluation of the first web-based computer tailored intervention program aimed at the prevention of binge drinking in Spanish adolescents (Alerta Alcohol). A Cluster Randomized Controlled Trial is conducted to test the effectiveness of Alerta Alcohol in students aged 16 to 18 years across 16 high schools from Andalusia (southern Spain), which are randomized either to the experimental or the control condition (EC and CC).
Detailed description
Binge-drinking in adolescents is a highly prevalent healthcare problem that associates physical and mental health complications and community implications.
The "Alerta Alcohol" program is based on the I-Change Model. Focus and Delphi groups are used to obtain further information on items included in the program. A pilot study is conducted to identify strengths and weaknesses. A Cluster Randomized Controlled Trial is carried out. The schools from Andalusia are randomized either to the experimental or the control condition (EC and CC). The EC receives the Alerta Alcohol intervention, which consists of four sessions at school: baseline questionnaire and two sessions 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. In addition, two booster sessions are given at home to reinforce the contents. 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 control condition). Evaluation takes place after four months. The primary endpoint is binge drinking within 30 days prior to evaluation and alcohol use in the previous week. It is expected that Alerta Alcohol reduces the prevalence of binge drinking by 10%. Follow up analyses are carried out to determine the differences in effectiveness according to the compliance of the program (quality of the implementation).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Cluster Randomized Controlled Trial is conducted to test the effectiveness of Alerta Alcohol in students aged 16 to 18 years. The study is performed in 16 high schools from Andalusia (southern Spain), which are randomized either to the experimental or the control condition (EC and CC). The EC receives the Alerta Alcohol intervention, which consists of four sessions at school. The adolescents are provided highly specific feedback regarding their knowledge, risk perception, self-esteem, attitude, social influence, and self-efficacy. In addition, two booster sessions are given at home to reinforce the contents of the three scenarios. 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 control condition).
| Arm | Type | Receives |
|---|---|---|
| Alerta Alcohol | Experimental | Behavioral: Alerta AlcoholIntervention Group: The Experimental Group receives the Alerta Alcohol intervention, which consists of four sessions at school (baseline questionnaire, two sessions in three scenarios: at home, celebrations, and public places, and a final evaluation). 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, two booster sessions are given at home to reinforce the contents of the three scenarios. Evaluation takes place after four months. |
| Control Group | No intervention | –Control Group: The Control Group just completes the baseline and the evaluation questionnaires and then they are allowed to receive the intervention as well (as a waiting list control condition). Evaluation takes place after four months from baseline |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Students aged 16 to 18 years.
- Enrolled in Andalusian public high schools.
- Schools belonging to provincial capitals.
- Access to the Internet at the school and an equipped ICT room.
Key exclusion criteria (2 listed)
- Language barriers.
- Previous participation in prevention programs for binge drinking.
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: Alerta Alcohol, a web-based computer-tailored 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 binge drinking, as well as social influence and self-efficacy, by personalized feedback. Skills and action plans are encouraged to help the student to reject binge drinking. This information is presented through different tailored messages. Moreover, four avatars (two males and two females), which can be chosen as part of the story development. This story consists of a short story about the alcohol consumption by adolescents.The stories take place in three different scenarios (at home, at celebrations and in public places). | Behavioural | Alerta Alcohol |
Primary outcome
Reducing binge-drinking
Time frame: 4 months after the baseline
Reducing binge-drinking (4/5 glasses or alcohol in one ocassion for a girl/boy) within 30 days prior to evaluation.
1 secondary outcome
Reducing weekly alcohol drinking
Time frame: 4 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 20 Sep 2017.
- Derived from this study: PubMed 36811462Vargas-Martinez AM, Lima-Serrano M, Trapero-Bertran M. Cost-effectiveness and cost-utility analyses of a web-based computer-tailored intervention for prevention of binge drinking among Spanish adolescents. Alcohol Clin Exp Res (Hoboken). 2023 Feb;47(2):319-335. doi: 10.1111/acer.14990. Epub 2023 Feb 22.
- Derived from this study: PubMed 32303203Vargas-Martinez AM, Trapero-Bertran M, Mora T, Lima-Serrano M. Social, economic and family factors associated with binge drinking in Spanish adolescents. BMC Public Health. 2020 Apr 17;20(1):519. doi: 10.1186/s12889-020-08605-9.
- Derived from this study: PubMed 32012064Martinez-Montilla JM, Mercken L, de Vries H, Candel M, Lima-Rodriguez JS, Lima-Serrano M. A Web-Based, Computer-Tailored Intervention to Reduce Alcohol Consumption and Binge Drinking Among Spanish Adolescents: Cluster Randomized Controlled Trial. J Med Internet Res. 2020 Jan 24;22(1):e15438. doi: 10.2196/15438.
- Derived from this study: PubMed 31590139Vargas-Martinez AM, Trapero-Bertran M, Lima-Serrano M, Anokye N, Pokhrel S, Mora T. Measuring the effects on quality of life and alcohol consumption of a program to reduce binge drinking in Spanish adolescents. Drug Alcohol Depend. 2019 Dec 1;205:107597. doi: 10.1016/j.drugalcdep.2019.107597. Epub 2019 Sep 30.
- Derived from this study: PubMed 29618331Lima-Serrano M, Martinez-Montilla JM, Lima-Rodriguez JS, Mercken L, de Vries H. Design, implementation and evaluation of a web-based computer-tailored intervention to prevent binge drinking in adolescents: study protocol. BMC Public Health. 2018 Apr 4;18(1):449. doi: 10.1186/s12889-018-5346-4.
- Individual participant dataSharing planned: Yes. The IPD will be shared with other researchers through publications in scientific journals and 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.
Marta Lima Serrano, PhD study director
University of Seville
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 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 20 Sep 2017. 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?
Reducing binge-drinking (time frame: 4 months after the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03288896, which also lists 5 linked publications.
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 20 Sep 2017.