High Schools- High on Life: an Intervention to Reduce Excessive Drinking in Danish High Schools

Sponsor
University of Southern Denmark (Other)
Overall Status
Terminated
CT.gov ID
NCT03906500
Collaborator
Danish Cancer Society (Other)
3,682
1
2
29
127.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: High schools High on Life
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
3682 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
High Schools- High on Life: an Intervention to Reduce Excessive Drinking in Danish High Schools
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Aug 30, 2021
Actual Study Completion Date :
Aug 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

The intervention consist of three main components. School environmental component 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 components The Student components consisted of three main elements: Web-based education for the student committees organizing events where alcohol is sold and the student introduction committee Pocket movie campaign Social norms campaign Parent components The parent component consisted of three separate elements: Parent Information Meeting Parent Information Folder Parent Information Website

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

No Intervention: control group

Control high schools was asked to continue business as usual and promised to receive the intervention in the school year starting in 2020

Outcome Measures

Primary Outcome Measures

  1. Mean number of binge drinking occasions within the last 30 days [12 months]

    30% lower number of binge drinking occasions within the last 30 days

Secondary Outcome Measures

  1. Weekly alcohol consumption [12 months]

    Mean weekly alcohol consumption

  2. Alcohol intake at last school party [12 months]

    Alcohol intake at last school party

  3. Alcohol intake at the school during last school party [12 months]

    Alcohol intake at the school during last school party

  4. Proportion that think alcohol play a too dominant part at the school [12 months]

    Proportion who think alcohol play a too dominant part at the school

Other Outcome Measures

  1. Social inclusion [12 months]

    Proportion of students who feel included in the social community at school, including students that do not drink or have a low alcohol intake

  2. Marihuana use [12 months]

    proportion of students who have smoked marihuana

  3. Other drug use [12 months]

    Proportion who have tried other drugs than marihuana

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institute of Public Health Copenhagen Denmark 1455

Sponsors and Collaborators

  • University of Southern Denmark
  • Danish Cancer Society

Investigators

  • Principal Investigator: Veronica Pisinger, the national institute of public health, Southern Denmark University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Veronica Pisinger, Research assistent, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT03906500
Other Study ID Numbers:
  • 15/4155_2
First Posted:
Apr 8, 2019
Last Update Posted:
Oct 6, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Veronica Pisinger, Research assistent, University of Southern Denmark
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021