Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03288896
Recruitment Status : Completed
First Posted : September 20, 2017
Last Update Posted : September 20, 2017
Sponsor:
Collaborators:
Junta de Andalucía
Maastricht University
Information provided by (Responsible Party):
Marta Lima Serrano, University of Seville

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
Alcohol Drinking Binge Drinking Adolescent Behavior Behavioral: Alerta Alcohol Not Applicable

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
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).
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 : November 1, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

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 Name: 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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Reducing weekly alcohol drinking [ Time Frame: 4 months after the baseline ]
    Reducing alcohol drinking within the 7 days prior to evaluation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288896


Locations
Layout table for location information
Spain
Marta Lima Serrano
Sevilla, Spain, 41009
Sponsors and Collaborators
University of Seville
Junta de Andalucía
Maastricht University
Investigators
Layout table for investigator information
Study Director: Marta Lima Serrano, PhD University of Seville

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Marta Lima Serrano, PhD, University of Seville
ClinicalTrials.gov Identifier: NCT03288896     History of Changes
Other Study ID Numbers: University of Seville. Spain
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The IPD will be shared with other researchers through publications in scientific journals and congresses
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marta Lima Serrano, University of Seville:
Adolescence
Alcohol Drinking
Binge Drinking
I-Change model
Web-based interventions
Computer-tailoring

Additional relevant MeSH terms:
Layout table for MeSH terms
Binge-Eating Disorder
Alcohol Drinking
Binge Drinking
Feeding and Eating Disorders
Mental Disorders
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs