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

Sponsor
University of Seville (Other)
Overall Status
Completed
CT.gov ID
NCT03288896
Collaborator
Junta de AndalucĂ­a (Other), Maastricht University (Other)
1,230
1
2
7.9
155.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Alerta Alcohol
N/A

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

Study Type:
Interventional
Actual Enrollment :
1230 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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).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)
Primary Purpose:
Prevention
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.
Actual Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Jun 30, 2017
Actual Study Completion Date :
Jun 30, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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).
Other Names:
  • Alerta Alcohol, a web-based computer-tailored intervention
  • No Intervention: Control Group

    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Reducing weekly alcohol drinking [4 months after the baseline]

      Reducing alcohol drinking within the 7 days prior to evaluation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marta Lima Serrano Sevilla Spain 41009

    Sponsors and Collaborators

    • University of Seville
    • Junta de AndalucĂ­a
    • Maastricht University

    Investigators

    • Study Director: Marta Lima Serrano, PhD, University of Seville

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marta Lima Serrano, PhD, University of Seville
    ClinicalTrials.gov Identifier:
    NCT03288896
    Other Study ID Numbers:
    • University of Seville. Spain
    First Posted:
    Sep 20, 2017
    Last Update Posted:
    Sep 20, 2017
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Marta Lima Serrano, PhD, University of Seville
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 20, 2017