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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03906500
Other study ID # 15/4155_2
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date August 30, 2021

Study information

Verified date September 2021
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

High schools High on life' intervention is a high school-based, multi-component intervention guided by theory, evidence, and empirical findings to reduce excessive drinking among Danish high school students. The study will employ a cluster-randomized controlled study design: investigators plan to include a random sample of at least 12 high schools randomly 1:1 allocated to either intervention or control group. Timeline: Baseline data will be obtained from the Danish National Youth Study 2019, collected in January to March 2019. Delivery of intervention: August 2019 to January 2020. Follow-up survey: April to May 2020. Primary outcome measure: mean number of binge-drinking episodes within the last 30 days. Secondary outcome measures: weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, number of students that agrees that they are able to have fun at a party without drinking, and the proportion of students that think alcohol plays a too dominant part at the school. Implementation will be monitored thorough process evaluation.


Description:

High schools High on life' intervention is a high school-based, multi-component intervention guided by theory, evidence, and empirical findings to reduce excessive drinking among Danish high school students. The study will employ a cluster-randomized controlled study design: based on sample size calculations investigators plan to include a random sample of at least 12 high schools randomly 1:1 allocated to either intervention or control group. Timeline: Baseline data will be obtained from the Danish National Youth Study 2019, collected in January to March 2019. Delivery of intervention: August 2019 to January 2020. Follow-up survey: April to May 2020. Primary outcome measure: mean number of binge-drinking episodes within the last 30 days. Secondary outcome measures: weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, number of students that agrees that they are able to have fun at a party without drinking, and the proportion of students that think alcohol plays a too dominant part at the school. Implementation will be monitored thorough process evaluation.


Recruitment information / eligibility

Status Terminated
Enrollment 3682
Est. completion date August 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 25 Years
Eligibility Inclusion Criteria: - Enrolled in High school that participate in The Danish National Youth Study 2019 - General High Schools Exclusion Criteria: - non General High schools students - non participation in The Danish National Youth Study 2019

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
High schools High on Life
The intervention consist of three main components. Environmental factors of the school environment The component targeting the high school environment consisted of two separate elements: Revision of school alcohol policy Appointment of coordinator(s) of student committees organizing events, where alcohol is sold, and student introduction committee. Student component The Student components consisted of three main elements: Online education for the student committees organizing events where alcohol is sold and the student introduction committee Pocket movie campaign competition Social norms campaign Parent component The parent component consisted of three separate elements: Parent Information Meeting Parent Information Folder Parent Information Website

Locations

Country Name City State
Denmark National Institute of Public Health Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
University of Southern Denmark Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Social inclusion Proportion of students who feel included in the social community at school, including students that do not drink or have a low alcohol intake 12 months
Other Marihuana use proportion of students who have smoked marihuana 12 months
Other Other drug use Proportion who have tried other drugs than marihuana 12 months
Primary Mean number of binge drinking occasions within the last 30 days 30% lower number of binge drinking occasions within the last 30 days 12 months
Secondary Weekly alcohol consumption Mean weekly alcohol consumption 12 months
Secondary Alcohol intake at last school party Alcohol intake at last school party 12 months
Secondary Alcohol intake at the school during last school party Alcohol intake at the school during last school party 12 months
Secondary Proportion that think alcohol play a too dominant part at the school Proportion who think alcohol play a too dominant part at the school 12 months
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