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

Not Applicable

Completed

• Conditions: Binge Drinking; Adolescent Behavior; Alcohol Drinking
• Interventions: Behavioral: Alerta Alcohol

• Registration Number: NCT03288896
• Lead Sponsor: University of Seville

Brief 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).

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 Timeline

• Study Start: 2016-11-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2017-09
• Study First Submitted: 2017-09-17
• Study First Submitted QC: 2017-09-19
• Last Update Submitted: 2017-09-19
• Study First Posted: 2017-09-20
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1230

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alerta Alcohol	Alerta Alcohol	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.

Primary Outcome Measures

Name	Time	Method
Reducing binge-drinking	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.

Secondary Outcome Measures

Name	Time	Method
Reducing weekly alcohol drinking	4 months after the baseline	Reducing alcohol drinking within the 7 days prior to evaluation

Trial Locations

Locations (1)

Marta Lima Serrano; 🇪🇸 Sevilla, Spain