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

September 19, 2017 updated by: Marta Lima Serrano, University of Seville

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain, 41009
        • Marta Lima Serrano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reducing binge-drinking
Time Frame: 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.
4 months after the baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reducing weekly alcohol drinking
Time Frame: 4 months after the baseline
Reducing alcohol drinking within the 7 days prior to evaluation
4 months after the baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Collaborators

Maastricht University
Junta de Andalucía

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

June 30, 2017

Study Completion (ACTUAL)

June 30, 2017

Study Registration Dates

First Submitted

September 17, 2017

First Submitted That Met QC Criteria

September 19, 2017

First Posted (ACTUAL)

September 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 20, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Seville. Spain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD will be shared with other researchers through publications in scientific journals and congresses

IPD Sharing Time Frame

From 2018

IPD Sharing Access Criteria

The Access Criteria will be the one exposed by the scientific journals where the results of the study will be published.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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