Alcohol Drinking Clinical Trial
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).
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).
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