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

Primary Purpose

Alcohol Drinking, Binge Drinking, Adolescent Behavior

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Alerta Alcohol
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking focused on measuring Adolescence, Alcohol Drinking, Binge Drinking, I-Change model, Web-based interventions, Computer-tailoring

Eligibility Criteria

16 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Marta Lima Serrano

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Alerta Alcohol

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Reducing binge-drinking
Reducing binge-drinking (4/5 glasses or alcohol in one ocassion for a girl/boy) within 30 days prior to evaluation.

Secondary Outcome Measures

Reducing weekly alcohol drinking
Reducing alcohol drinking within the 7 days prior to evaluation

Full Information

First Posted
September 17, 2017
Last Updated
September 19, 2017
Sponsor
University of Seville
Collaborators
Junta de Andalucía, Maastricht University
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1. Study Identification

Unique Protocol Identification Number
NCT03288896
Brief Title
Alerta Alcohol. Web-based Computer-tailored Intervention for Binge-drinking Prevention in Spanish Adolescents
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
Collaborators
Junta de Andalucía, Maastricht University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Binge Drinking, Adolescent Behavior
Keywords
Adolescence, Alcohol Drinking, Binge Drinking, I-Change model, Web-based interventions, Computer-tailoring

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alerta Alcohol
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Alerta Alcohol
Other Intervention Name(s)
Alerta Alcohol, a web-based computer-tailored intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Reducing binge-drinking
Description
Reducing binge-drinking (4/5 glasses or alcohol in one ocassion for a girl/boy) within 30 days prior to evaluation.
Time Frame
4 months after the baseline
Secondary Outcome Measure Information:
Title
Reducing weekly alcohol drinking
Description
Reducing alcohol drinking within the 7 days prior to evaluation
Time Frame
4 months after the baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Lima Serrano, PhD
Organizational Affiliation
University of Seville
Official's Role
Study Director
Facility Information:
Facility Name
Marta Lima Serrano
City
Sevilla
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
32303203
Citation
Vargas-Martinez AM, Trapero-Bertran M, Mora T, Lima-Serrano M. Social, economic and family factors associated with binge drinking in Spanish adolescents. BMC Public Health. 2020 Apr 17;20(1):519. doi: 10.1186/s12889-020-08605-9.
Results Reference
derived
PubMed Identifier
32012064
Citation
Martinez-Montilla JM, Mercken L, de Vries H, Candel M, Lima-Rodriguez JS, Lima-Serrano M. A Web-Based, Computer-Tailored Intervention to Reduce Alcohol Consumption and Binge Drinking Among Spanish Adolescents: Cluster Randomized Controlled Trial. J Med Internet Res. 2020 Jan 24;22(1):e15438. doi: 10.2196/15438.
Results Reference
derived
PubMed Identifier
31590139
Citation
Vargas-Martinez AM, Trapero-Bertran M, Lima-Serrano M, Anokye N, Pokhrel S, Mora T. Measuring the effects on quality of life and alcohol consumption of a program to reduce binge drinking in Spanish adolescents. Drug Alcohol Depend. 2019 Dec 1;205:107597. doi: 10.1016/j.drugalcdep.2019.107597. Epub 2019 Sep 30.
Results Reference
derived
PubMed Identifier
29618331
Citation
Lima-Serrano M, Martinez-Montilla JM, Lima-Rodriguez JS, Mercken L, de Vries H. Design, implementation and evaluation of a web-based computer-tailored intervention to prevent binge drinking in adolescents: study protocol. BMC Public Health. 2018 Apr 4;18(1):449. doi: 10.1186/s12889-018-5346-4.
Results Reference
derived

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

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