NCT03288896

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

September 17, 2017

Last Update Submit

September 19, 2017

Conditions

Alcohol DrinkingBinge DrinkingAdolescent Behavior

Keywords

AdolescenceAlcohol DrinkingBinge DrinkingI-Change modelWeb-based interventionsComputer-tailoring

Outcome Measures

Primary Outcomes (1)

  • Reducing binge-drinking

    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 Outcomes (1)

  • Reducing weekly alcohol drinking

    4 months after the baseline

Study Arms (2)

Alerta Alcohol

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Alerta AlcoholBEHAVIORAL

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).

Also known as: Alerta Alcohol, a web-based computer-tailored intervention
Alerta Alcohol

Eligibility Criteria

Age16 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Language barriers.
  • Previous participation in prevention programs for binge drinking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marta Lima Serrano

Seville, 41009, Spain

Location

Related Publications (5)

  • Vargas-Martinez AM, Lima-Serrano M, Trapero-Bertran M. Cost-effectiveness and cost-utility analyses of a web-based computer-tailored intervention for prevention of binge drinking among Spanish adolescents. Alcohol Clin Exp Res (Hoboken). 2023 Feb;47(2):319-335. doi: 10.1111/acer.14990. Epub 2023 Feb 22.

    PMID: 36811462DERIVED

  • 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.

    PMID: 32303203DERIVED

  • 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.

    PMID: 32012064DERIVED

  • 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.

    PMID: 31590139DERIVED

  • 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.

    PMID: 29618331DERIVED

MeSH Terms

Conditions

Alcohol DrinkingBinge DrinkingAdolescent Behavior

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Marta Lima Serrano, PhD

    University of Seville

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 17, 2017

First Posted

September 20, 2017

Study Start

November 1, 2016

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

September 20, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
From 2018
Access Criteria
The Access Criteria will be the one exposed by the scientific journals where the results of the study will be published.

Locations

ES(1)