Alerta Alcohol. Web-based Computer-tailored Intervention for Binge-drinking Prevention in Spanish Adolescents

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288896
• Other study ID #: University of Seville. Spain
• Status: Completed
• Phase: N/A
• First received: September 17, 2017
• Last updated: September 19, 2017
• Start date: November 1, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: September 2017
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1230
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Language barriers.

• Previous participation in prevention programs for binge drinking.

Related Conditions & MeSH terms

• Adolescent Behavior
• Alcohol Drinking
• Binge Drinking
• Binge-Eating Disorder

Intervention

Behavioral:
• 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 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).

Locations

Country	Name	City	State
Spain	Marta Lima Serrano	Sevilla

Sponsors (3)

Lead Sponsor	Collaborator
University of Seville	Junta de Andalucía, Maastricht University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reducing binge-drinking	Reducing binge-drinking (4/5 glasses or alcohol in one ocassion for a girl/boy) within 30 days prior to evaluation.	4 months after the baseline
Secondary	Reducing weekly alcohol drinking	Reducing alcohol drinking within the 7 days prior to evaluation	4 months after the baseline