Clinical trial NCT03906500: High Schools- High on Life: an Intervention to Reduce Excessive Drinking in Danish High Schools
Official title: High Schools- High on Life: an Intervention to Reduce Excessive Drinking in Danish High Schools
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alcohol Drinking
Keywords: Adolescence
Alcohol use
High school
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2019-04-08
Enrollment: 3682
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean number of binge drinking occasions within the last 30 days
timeFrame: 12 months
Secondary outcomes:
measure: Weekly alcohol consumption
timeFrame: 12 months
measure: Alcohol intake at last school party
timeFrame: 12 months
measure: Alcohol intake at the school during last school party
timeFrame: 12 months
measure: Proportion that think alcohol play a too dominant part at the school
timeFrame: 12 months
Other outcomes:
measure: Social inclusion
timeFrame: 12 months
measure: Marihuana use
timeFrame: 12 months
measure: Other drug use
timeFrame: 12 months
Locations:
city: Copenhagen
country: Denmark
facility: National Institute of Public Health
Study officials:
affiliation: the national institute of public health, Southern Denmark University
name: Veronica Pisinger
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.