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An Animation- Versus Text-based Computer-tailored Game Intervention to Prevent Alcohol Consumption in Adolescents

Primary Purpose

Alcohol Drinking, Binge Drinking, Adolescent Behavior

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Alerta Alcohol
Alerta Alcohol 2.0
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 Alcohol use, Binge drinking, High-intensity drinking, Adolescents, Web-based interventions, Computer-tailoring, Animation

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Students aged 14 to 19 years.
  • Enrolled in Andalusian public or private high schools.
  • Access to the Internet at the schools and the use of computer, mobile or tablet is allowed.
  • Access to the Internet in their homes.

Exclusion Criteria:

  • Language barriers.
  • Previous participation in prevention programs for BD.

Sites / Locations

  • Marta Lima Serrano

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Alerta Alcohol

Alerta Alcohol 2.0

Control condition

Arm Description

The EC-1 receives Alerta Alcohol, which consists of session 1 or baseline, two sessions in three scenarios: at home, celebrations, and public places, and two follow-up evaluations. 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, four booster sessions are given at home to reinforce the contents of the three scenarios. Evaluations take place after six and twelve months.

The EC-2 receives an improved version of Alerta Alcohol (Alerta Alcohol 2.0) using animated videos and new gamification strategies. Evaluations take place after six and twelve months.

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). Evaluations take place after six and twelve months from baseline.

Outcomes

Primary Outcome Measures

Change on the prevalence of binge drinking
Change on the prevalence of binge drinking (4/5 standard drink units or standard glasses of alcohol in one occasion for a girl/boy) within 30 days prior to evaluation.
Change on the prevalence of binge drinking
Change on the prevalence of binge drinking (4/5 standard drink units or standard glasses of alcohol in one occasion for a girl/boy) within 30 days prior to evaluation.

Secondary Outcome Measures

Change on the prevalence of high-intensity drinking
Change on the prevalence of high-intensity drinking (8/10 standard drink units or standard glasses of alcohol in one occasion for a girl/boy) within the 7 days prior to evaluation.
Change on the prevalence of high-intensity drinking
Change on the prevalence of high-intensity drinking (8/10 standard drink units or standard glasses of alcohol in one occasion for a girl/boy) within the 7 days prior to evaluation.
Change on the average of weekly consumption
Change on the average of the total number of glasses consumed within the 7 days prior to evaluation.
Change on the average of weekly consumption
Change on the average of the total number of glasses consumed within the 7 days prior to evaluation.
Change on the prevalence of any consumption
Change on the prevalence of any consumption
Change on the prevalence of any consumption
Change on the prevalence of any consumption

Full Information

First Posted
April 9, 2021
Last Updated
October 9, 2022
Sponsor
University of Seville
Collaborators
Delegación del Gobierno para el Plan Nacional sobre Drogas, Maastricht University
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1. Study Identification

Unique Protocol Identification Number
NCT04853628
Brief Title
An Animation- Versus Text-based Computer-tailored Game Intervention to Prevent Alcohol Consumption in Adolescents
Official Title
ALERTA ALCOHOL: The Development and Evaluation of an Animation- Versus Text-based Computer-tailored Game Intervention to Prevent Alcohol Consumption and Binge Drinking in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
Collaborators
Delegación del Gobierno para el Plan Nacional sobre Drogas, 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 design, implementation and evaluation of an animation (Alerta Alcohol 2.0)- versus text-based (Alerta Alcohol) computer-tailored game intervention aimed to prevent alcohol consumption and binge drinking (BD) in Spanish adolescents. A Cluster Randomized Controlled Trial (CRCT) is conducted to test the effectiveness of Alerta Alcohol versus Alerta Alcohol 2.0 in students aged 14 to 19 years across 24 high schools from Andalusia (southern Spain), which are randomized either to the experimental (EC-1, EC-2) or the control conditions (CC).
Detailed Description
Alcohol use and misuse, and particularly, BD in adolescents are a highly prevalent healthcare problem that associates physical and mental health complications and community implications. The Alerta Alcohol and Alerta Alcohol 2.0 programs are based on the I-Change Model. A CRCT is carried out. The schools from Andalusia are randomized either to the experimental (EC-1, EC-2) or the control conditions (CC). The EC-1 receives an online intervention (Alerta Alcohol, which has adapted from a previous version) with personalized health advice, using textual feedback and several gamification techniques, and consists of nine sessions (performing seven of them at the high school): session 1 or baseline, sessions 2 and 3 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; sessions 4, 5, 7 and 8 are reinforcement sessions (booster sessions) and sessions 6 and 9 are follow-up questionnaires at six and twelve months. The EC-2 receives an improved version of Alerta Alcohol (Alerta Alcohol 2.0) using animated videos and new gamification strategies. 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). To test the effectiveness, the primary outcome is BD within 30 days prior to evaluation and alcohol use (high-intensity drinking, weekly and any consumption) in the previous week as secondary outcomes.

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
Alcohol use, Binge drinking, High-intensity drinking, Adolescents, Web-based interventions, Computer-tailoring, Animation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is performed in 24 high schools from Andalusia (southern Spain), which are randomized either to the experimental (EC-1, EC-2) or the control conditions (CC). The EC-1 receives Alerta Alcohol, with personalized health advice, using textual feedback and several gamification techniques; and consists of nine sessions (performing seven of them at the high school): session 1 or baseline, sessions 2 and 3 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; sessions 4, 5, 7 and 8 are reinforcement sessions (booster sessions) and sessions 6 and 9 are follow-up questionnaires at six and twelve months. The EC-2 receives Alerta Alcohol 2.0, using animated videos and new gamification strategies. The CC just completes the baseline and the evaluation questionnaires.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2625 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alerta Alcohol
Arm Type
Experimental
Arm Description
The EC-1 receives Alerta Alcohol, which consists of session 1 or baseline, two sessions in three scenarios: at home, celebrations, and public places, and two follow-up evaluations. 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, four booster sessions are given at home to reinforce the contents of the three scenarios. Evaluations take place after six and twelve months.
Arm Title
Alerta Alcohol 2.0
Arm Type
Experimental
Arm Description
The EC-2 receives an improved version of Alerta Alcohol (Alerta Alcohol 2.0) using animated videos and new gamification strategies. Evaluations take place after six and twelve months.
Arm Title
Control condition
Arm Type
No Intervention
Arm Description
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). Evaluations take place after six and twelve months from baseline.
Intervention Type
Behavioral
Intervention Name(s)
Alerta Alcohol
Other Intervention Name(s)
A text-based computer-tailored game 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 BD, as well as social influence and self-efficacy, by personalized feedback. Skills and action plans are encouraged to help the student to reject BD. This information is presented through different tailored text messages. Moreover, several gamification strategies are used (i.e. offering a challenge, giving different stories and the use of avatars in these stories that take place in three different scenarios: at home, at celebrations and in public places).
Intervention Type
Behavioral
Intervention Name(s)
Alerta Alcohol 2.0
Other Intervention Name(s)
An animation-based computer-tailored game 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 BD, as well as social influence and self-efficacy, by personalized feedback. Skills and action plans are encouraged to help the student to reject BD. This information is presented through different animated videos. Moreover, new gamification strategies are added (i.e. giving rewards and allocating points that can be accumulated and shown in a progress ranking) to those already used in Alerta Alcohol.
Primary Outcome Measure Information:
Title
Change on the prevalence of binge drinking
Description
Change on the prevalence of binge drinking (4/5 standard drink units or standard glasses of alcohol in one occasion for a girl/boy) within 30 days prior to evaluation.
Time Frame
6 months after the baseline
Title
Change on the prevalence of binge drinking
Description
Change on the prevalence of binge drinking (4/5 standard drink units or standard glasses of alcohol in one occasion for a girl/boy) within 30 days prior to evaluation.
Time Frame
12 months after the baseline
Secondary Outcome Measure Information:
Title
Change on the prevalence of high-intensity drinking
Description
Change on the prevalence of high-intensity drinking (8/10 standard drink units or standard glasses of alcohol in one occasion for a girl/boy) within the 7 days prior to evaluation.
Time Frame
6 months after the baseline
Title
Change on the prevalence of high-intensity drinking
Description
Change on the prevalence of high-intensity drinking (8/10 standard drink units or standard glasses of alcohol in one occasion for a girl/boy) within the 7 days prior to evaluation.
Time Frame
12 months after the baseline
Title
Change on the average of weekly consumption
Description
Change on the average of the total number of glasses consumed within the 7 days prior to evaluation.
Time Frame
6 months after the baseline
Title
Change on the average of weekly consumption
Description
Change on the average of the total number of glasses consumed within the 7 days prior to evaluation.
Time Frame
12 months after the baseline
Title
Change on the prevalence of any consumption
Description
Change on the prevalence of any consumption
Time Frame
6 months after the baseline
Title
Change on the prevalence of any consumption
Description
Change on the prevalence of any consumption
Time Frame
12 months after the baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Students aged 14 to 19 years. Enrolled in Andalusian public or private high schools. Access to the Internet at the schools and the use of computer, mobile or tablet is allowed. Access to the Internet in their homes. Exclusion Criteria: Language barriers. Previous participation in prevention programs for BD.
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 conferences/congresses.
IPD Sharing Time Frame
From 2021.
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.

Learn more about this trial

An Animation- Versus Text-based Computer-tailored Game Intervention to Prevent Alcohol Consumption in Adolescents

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