Condition category
Mental and Behavioural Disorders
Date applied
23/09/2019
Date assigned
11/10/2019
Last edited
11/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
High alcohol consumption puts people at risk of poor health, and can also be bad for society. Since most adults in Sweden are in work, the workplace provides an important place to deliver an alcohol prevention programme. The overall aim of this study is to investigate potential effects of an alcohol prevention programme in workplaces.

Who can participate?
Organisations with above-average hazardous alcohol consumption and at least 100 employees. The employee participants must be aged at least 16 years and work at the organisation for at least 2 years after the organisation enters the study.

What does the study involve?
Organisations will be randomly allocated to one of two groups. Group 1 will receive training by Alna, a non-profit organisation that provides addiction prevention services. The training helps organisations to develop an implement an alcohol policy, and provides skills training for managers. Skills training aims to aid managers to identify early signs of hazardous alcohol consumption and increase managers’ confidence to address problems with alcohol early. Group 2 will receive the same training 1 year after Group 1. Managers and employees in all organisations are assessed using self-administered questionnaires at the beginning of the study, as well as 12 and 24 months later.

What are the possible benefits and risks of participating?
Managers will be able to identify early signs of hazardous alcohol consumption in the organisation and will be more likely to initiate early alcohol interventions. There is no direct physical or psychological harm to participating in the study.

Where is the study run from?
Department of Public Health Sciences, Stockholm University (Sweden)

When is the study starting and how long is it expected to run for?
January 2018 to December 2020

Who funds the study?
The Public Health Agency of Sweden

Who are the main contacts?
1. Dr. Kristina Sundqvist, kristina.sundqvist@su.se
2. Prof. Peter Wennberg, peter.wennberg@su.se

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Wennberg

ORCID ID

http://orcid.org/0000-0002-0013-2965

Contact details

Department of Public Health Sciences
Stockholm University
Stockholm
SE - 106 91
Sweden
+46 (0)8 16 20 00
peter.wennberg@su.se

Type

Public

Additional contact

Dr Kristina Sundqvist

ORCID ID

http://orcid.org/0000-0002-5923-0092

Contact details

Department of Psychology
Stockholm University
Stockholm
SE - 106 91
Sweden
+46 (0)8 16 14 25
kristina.sundqvist@su.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

N/A

Study information

Scientific title

Cluster randomised study of an alcohol prevention programme in the workplace

Acronym

KAPRI

Study hypothesis

To evaluate whether the alcohol prevention programme, which consists of organisational alcohol policy development and skills training among manager, leads to:
1. An increase in the reporting of inclination to engage in a conversation with an employee when suspicion and or worry about hazardous alcohol consumption arises
2. An increase in the employees' knowledge about where in the workplace one might get support in regarding hazardous alcohol consumption
3. An increased number of early interventions by managers (e.g. by engaging in a dialogue) to help employees with hazardous alcohol consumption or other types of harmful use
4. Managers and employees engaging in more sustainable alcohol use as measured by sum of Alcohol Use Disorder Identification Test (AUDIT) categories
5. Fewer cases of hazardous alcohol consumption among managers and employees as measured by AUDIT scores
6. Managers reporting being more confident in handling hazardous alcohol consumption in the workplace

Ethics approval

Approved 12/04/2018, Regional Ethical Board in Stockholm (FE 289, 171 77 Stockholm, Sweden; +46 (0)8 524 870 00; kansli@stockholm.epn.se), ref: 2018/634-31/5

Study design

Cluster randomised study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet.

Condition

Alcohol harm prevention delivered in the workplace

Intervention

Randomisation
The organisations were matched based on type of sector (e.g. hospitality sector) and size of organisations into blocks. Each block is allocated to either intervention or control group by a computer-generated program (random.org)

Intervention group
The first component focuses on implementation of organisational alcohol. Alna will assist managers to improve and implement organisational alcohol policy, where the policy is based on Alna’s previous experiences. This includes examples on responsibility and operational plan. The policy will be executed together with managers on three to four occasions, each lasting for approximately 2 h, depending on the availability of the organisation.
The second component of the programme is skills development training, with the purpose of helping managers to be able to identify early signals of hazardous alcohol consumption and to be able to act upon signs of behaviours that may lead to adverse effects for both employees and the organisation. Managers will attend two training workshops directed by Alna, which lasts for 3.5 h per session. The workshop will cover various topics regarding addiction, prevention and dialogues about hazardous use of alcohol. At the end of the second session, a ‘checklist for managers regarding alcohol use’ will be introduced. This checklist includes topics such as: different types of alcohol use; prevalence of alcohol use; risk factors; tools to start a dialogue with employees; signs to identify hazardous alcohol use; the role of workplace culture and policy in alcohol consumption; roles and responsibility of the organisation; implementation checklist to understand purpose of the intervention; and discussions on ambiguous cases.

Control group
Organisations that have been allocated to the control group will be placed on a waitlist and will continue their usual practice. Control organisations will receive the same prevention programme as the intervention group after 12 months follow-up.


Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Managers' self-rated inclination to initiate early alcohol interventions by engaging in a dialogue with employees who may have hazardous alcohol consumption, measured using a 5-point Likert scale at baseline, 12- and 24-months follow-up periods

Secondary outcome measures

The following will be assessed at baseline, 12- and 24-months follow up, using self-administered questionnaires for managers and employees. Questionnaires will investigate:
1. Knowledge about where to support regarding hazardous alcohol consumption
2. Whether hazardous alcohol consumption has made them worried or made them take action
3. Change in alcohol consumption
4. Level of alcohol problems among managers and employees

Overall trial start date

01/01/2018

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Cluster level
1. Organisations with over-representation of hazardous alcohol consumption

Individuals
2. Aged 16 years
3. Working in the recruited organisation at the time of recruitment and the follow-up endpoint

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

13 organisations (at least 100 participants in each cluster)

Participant exclusion criteria

Cluster level
1. Organisations that want to change from intervention to control group and vice versa after randomisation

Individual level
2. Participants who do not work at the organisation at the time of recruitment or follow-up periods

Recruitment start date

01/03/2018

Recruitment end date

30/09/2020

Locations

Countries of recruitment

Sweden

Trial participating centre

Stockholm University
Department of Public Health Sciences Stockholm University
Stockholm
SE-106 91
Sweden

Sponsor information

Organisation

Stockholm University

Sponsor details

Department of Public Health Sciences
Stockholm University
Stockholm
SE 106-91
Sweden
+46 8 16 20 00
mikael.rostila@su.se

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Folkhälsomyndigheten

Alternative name(s)

Public Health Agency of Sweden

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Sweden

Results and Publications

Publication and dissemination plan

Planned publication in high-impact peer-reviewed journals and presentations at international conferences.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available because the study involves sensitive personal information, such as alcohol habits.

Intention to publish date

31/10/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/09/2019: Trial's existence confirmed by Stockholm Regional Ethics Board.