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

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.

Study Overview

• Status: Terminated
• Conditions: Alcohol Drinking
• Intervention / Treatment: Behavioral: High schools High on Life

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 Type: Interventional
• Enrollment (Actual): 3682
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 1455
    • National Institute of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly alcohol consumption	Mean weekly alcohol consumption	12 months
Alcohol intake at last school party	Alcohol intake at last school party	12 months
Alcohol intake at the school during last school party	Alcohol intake at the school during last school party	12 months
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Marihuana use	proportion of students who have smoked marihuana	12 months
Other drug use	Proportion who have tried other drugs than marihuana	12 months

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Danish Cancer Society
• Investigators: Principal Investigator: Veronica Pisinger, the national institute of public health, Southern Denmark University

Publications and helpful links

General Publications

• Pisinger VSC, Hoffmann SH, Palsson L, Dalum P, Gronbaek MK, Tolstrup JS, Thygesen LC, Krolner RF. 'High schools High on life': Development of an Intervention to Reduce Excessive Drinking in Danish High Schools. Front Public Health. 2020 Sep 15;8:435. doi: 10.3389/fpubh.2020.00435. eCollection 2020.
• Pisinger VSC, Hoffmann S, Rosing JA, Gronbaek M, Tolstrup JS, Thygesen L, Krolner R. Study protocol for a cluster randomised controlled trial testing the effectiveness of the 'High schools High on life' intervention on reducing excessive drinking in Danish high schools. BMJ Open. 2020 Aug 6;10(8):e038857. doi: 10.1136/bmjopen-2020-038857.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Adolescence; Alcohol use; High school
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 15/4155_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No