An interventional study of Alerta Alcohol in Alcohol Drinking, Binge Drinking and Adolescent Behavior, sponsored by University of Seville. Completed at 1 site in Spain. Open to participants aged 16 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-20.
Sponsored by University of Seville · Not applicable, Interventional, and Prevention
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).
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).
71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.
This study's enrollment of 1,230 is above the median of 120 across 64 interventional studies indexed under Binge Drinking.
Browse Binge Drinking studies →University of Seville is the lead sponsor of 130 studies on the registry; 39 are open to participants now.
Compared within Binge Drinking, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Alcohol Drinking. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Alerta Alcohol
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
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).
Also known as: Alerta Alcohol, a web-based computer-tailored intervention
Reducing binge-drinking
Reducing binge-drinking (4/5 glasses or alcohol in one ocassion for a girl/boy) within 30 days prior to evaluation.
Time frame: 4 months after the baseline
Reducing weekly alcohol drinking
Reducing alcohol drinking within the 7 days prior to evaluation
Time frame: 4 months after the baseline
Plan to share: Yes — The IPD will be shared with other researchers through publications in scientific journals and congresses
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: From 2018
Access criteria: The Access Criteria will be the one exposed by the scientific journals where the results of the study will be published.
Ran from Nov 2016 to primary completion in Jun 2017, 7 months.
Of 38 interventional studies with no phase under Binge Drinking, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 49. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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