Clinical trial NCT03288896: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Binge Drinking
Adolescent Behavior
Keywords: Adolescence
Alcohol Drinking
Binge Drinking
I-Change model
Web-based interventions
Computer-tailoring
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: Junta de Andalucia
name: Maastricht University
First posted: 2017-09-20
Enrollment: 1230
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Reducing binge-drinking
timeFrame: 4 months after the baseline
Secondary outcomes:
measure: Reducing weekly alcohol drinking
timeFrame: 4 months after the baseline
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Marta Lima Serrano
Study officials:
affiliation: University of Seville
name: Marta Lima Serrano, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.