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Healthy ParticipantsNCT06018389

Prevention of Hazardous Use of Alcohol with Danish High School Students (Our Choice)

A study testing Structural only and Structural+Group MI in people with Healthy Participants, run by University of Aarhus at 1 site in Denmark.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The trial 'Our Choice' examines the effect of two prevention interventions targeting school, parent, and student levels at Danish high schools. The interventions aim to reduce hazardous use of alcohol and related health outcomes among first-year students in Denmark (ages 15-18). Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Structural only and Structural+Group MI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,100 participants
Where
1 siteDenmark
Study dates
9 Aug 2023to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Students starting high school in one of the 16 participating high schools in August 2023
  • Minimum 15 years old
  • Understand and speak Danish
  • Able to give independent informed consent
  • Staff (school principals, teachers, or administrative employees) from one of the 16 participating high schools

Who cannot join

  • Under 15 years old

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Denmark1 site

  • Centre for Alcohol and Drug Research, Aarhus BSS, Aarhus University

    Aarhus

Other trials in Denmark

About this study

Official title: Prevention of Hazardous Use of Alcohol Among High School Students in Denmark: a Cluster Randomized Controlled Trial

The trial 'Our Choice' examines the effect of two prevention interventions targeting school, parent, and student levels at Danish high schools. The interventions aim to reduce hazardous use of alcohol and related health outcomes among first-year students in Denmark (ages 15-18). The investigators hypothesizes that a structural intervention (school and parent levels) reduces hazardous alcohol use and related health outcomes compared to an assessment-only control group 12 months post baseline; and that adding group-based Motivational Interviewing (group MI) yields further improvements. Additionally, factors related to the implementation of the interventions are examined.

Read the detailed description

The main aim of the 'Our Choice' cluster randomized controlled multisite trial is to test the efficacy of interventions aimed at reducing hazardous use of alcohol and related health outcomes among first-year students (15-18 years) in high schools in Denmark. Furthermore, the aim is to examine feasibility and acceptability of the interventions with Danish students in high school, as well as with staff (e.g., teachers and principals) to inform future implementation studies.

The study employs a parallel group cluster randomized controlled trial design with three conditions:

  1. Structural condition targeting school and parent levels via school policies for school-based social events and an information-based interactive parent meeting.
  2. Structural condition combined with group-based Motivational Interviewing (group MI) which also targets the student level.
  3. Assessment-only control condition with the same assessments as the other two conditions and with interventions offered after the last follow-up survey.

The study hypothesizes that students in the structural condition (school and parent levels) reduce hazardous alcohol use and related health outcomes compared to students in the assessment-only control condition 12 months post baseline; and that adding group MI yields further improvements.

A participatory approach is used to adapt and develop interventions. Sixteen high schools in Denmark and N=3100 first-year students enrolled in high school in August 2023 will be recruited. Data will be collected via online questionnaires pre-interventions (baseline), 2, 6, 9 and 12 months post baseline. The primary outcome will be analyzed with generalized linear mixed models. Feasibility and acceptability will be assessed via surveys (students) and interviews (high school staff) to inform future implementation.

Being tested
Structural only, Structural+Group MI
Keywords
Prevention, High School, Alcohol, Substance Use, Adolescents, Motivational Interviewing, School Policies, Parents
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structural onlyBehavioural

    A shared list of school policies for or related to, school-based social events at school premises. The policy initiatives include (but are not limited to): increasing the number of social events without alcohol; promoting non-alcoholic beverages at parties; working with student associations regarding their roles and responsibilities; encouraging parental involvement at school events and disseminating the schools' alcohol policy among students and parents. The school principal and management will be responsible for the implementation and enforcement of the policies.

    The Information-based interactive parent meetings will be 45 minutes and will take place at the schools. Parents will be offered concrete, research-informed advice about how they can reduce risk of hazardous substance use and promote well-being among their adolescents. Following a 15-minute presentation, the group leader facilitates a discussion and exchange of experience between parents.

  • Structural+Group MIBehavioural

    Within school classes, students are divided into groups of 5-8 students and each group will be assigned a group leader from the research team. The group-based Motivational Interviewing (group MI) is manualized and consists of two one-hour group sessions administered over two consecutive weeks. The first session is focused on "Tell your story", "Gains from not drinking", and "Social norms." In the second session, the focus is on "Personal values", "Linking values with behavior" and "Planning/choices regarding alcohol". Both group MI sessions will take place at the schools during the school day.

Study groups in NCT06018389
Study groupRoleWhat they receive
Structural OnlyExperimentalThe Structural Only condition consists of (1) school policies for school-based social events; and (2) an information-based interactive parent meeting. Interventions in this arm are targeting the school and parent level.
Receives: Behavioral: Structural only
Structural+Group MIExperimentalThe Structural+Group MI condition consists of the elements described in "Structural Only" and group MI. Interventions in this arm are targeting all three levels: school, parent and student level.
Receives: Behavioral: Structural only; Behavioral: Structural+Group MI
ControlNo interventionThe Control condition is an assessment-only condition. During the period under study, it includes the same assessments (surveys) as the other two conditions. After the last follow-up (August 2024), control schools can opt-in to receive any of the intervention programs.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Past month high-intensity drinking

    Past month high-intensity drinking: peak drinks per drinking event, assessed with the Timeline FollowBack (TLFB) (count measure)

    Measured: From baseline to 12 months after baseline

Secondary outcomes (6)

  1. Past month alcohol-related consequences

    Assessed by 21 items covering physical, social and mental issues related to hazardous use of alcohol, developed by the team for Danish youth based on single items from previous Danish surveys and the Rutgers Alcohol Problems Index e.g. black-outs, (emotional) hangovers), sexual contact that was later regretted, with yes/no response options (summed score: range 0-21) with higher scores indicating more negative consequences.

    Measured: From baseline to 12 months after baseline

  2. Past month heavy episodic drinking events

    Past month heavy episodic drinking events assessed by TLFB (count measure).

    Measured: From baseline to 12 months after baseline

  3. Well-being in class

    Assessed by six items rated on a five-point scale from 'completely disagree' to 'completely agree' e.g., I feel accepted by the others in my class (summed score: range 0-30) with a score of 30 representing the best possible well-being in class.

    Measured: From baseline to 12 months after baseline

  4. World Health Organization Five Well-being Index (WHO-5)

    Psychological well-being, assessed by The World Health Organization Five Well-being Index (summed score: range 0-25) with a score of 25 representing the best possible quality of life.

    Measured: From baseline to 12 months after baseline

  5. Past month use of tobacco

    Measured by days using tobacco (count measure: range 0-30 days)

    Measured: From baseline to 12 months after baseline

  6. Past month use of illegal substances

    Measured by days using cannabis, cocaine, and other illegal drugs (count measure: range 0-30 days).

    Measured: From baseline to 12 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2023
  2. Study start9 Aug 2023
  3. Primary completionAug 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study employs a parallel group cluster randomized controlled trial design with three conditions: 1) structural condition targeting school and parent levels, 2) structural condition combined with group MI which also targets the student level, and 3) assessment-only control condition (interventions offered after the last follow-up survey).
Masking
None (open label)
Enrolment
3,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06018389
Sponsor's protocol ID
voresvalg_40833
Other IDs
2022-0367531 seqno. 3073, ID: 155933
Status last verified
Dec 2024
First submitted
24 Aug 2023
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: After the conclusion of the study, data from the study will be made available by the Centre for Alcohol and Drug Research, Aarhus University, upon reasonable request, and within the limitations set by the Danish data protection legislation and regulation.

Publications

  • Romer Thomsen K, Vallentin-Holbech L, Xylander S, Wellnitz KB, Tolstrup J, Nielsen AS, Ewing SWF. Prevention of hazardous use of alcohol among high school students: a study protocol for the randomized controlled trial 'Our choice'. BMC Public Health. 2023 Oct 24;23(1):2079. doi: 10.1186/s12889-023-16976-y.

    PubMed 37875851

  • Vallentin-Holbech L, Dash GF, Feldstein Ewing SW, Nielsen AS, Tolstrup JS, Wellnitz KB, Ornbol E, Romer Thomsen K. Three-Arm Randomized Controlled Trial of Motivational Interviewing for Adolescent Drinking in Denmark. J Am Acad Child Adolesc Psychiatry. 2026 Jul 16:S0890-8567(26)00321-7. doi: 10.1016/j.jaac.2026.07.009. Online ahead of print.

    PubMed 42462842

Questions about this trial

What is this clinical trial studying?

A study testing Structural only and Structural+Group MI in people with Healthy Participants, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Past month high-intensity drinking (time frame: From baseline to 12 months after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06018389, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.

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