ISRCTN ISRCTN17250048
DOI https://doi.org/10.1186/ISRCTN17250048
Secondary identifying numbers N/A
Submission date
23/09/2019
Registration date
11/10/2019
Last edited
18/11/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Peter Wennberg
Scientific

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

ORCiD logoORCID ID 0000-0002-0013-2965
Phone +46 (0)8 16 20 00
Email peter.wennberg@su.se
Dr Kristina Sundqvist
Public

Department of Psychology
Stockholm University
Stockholm
SE - 106 91
Sweden

ORCiD logoORCID ID 0000-0002-5923-0092
Phone +46 (0)8 16 14 25
Email kristina.sundqvist@su.se

Study information

Study designCluster randomised study
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a participant information sheet.
Scientific titleCluster randomised study of an alcohol prevention programme in the workplace
Study acronymKAPRI
Study objectivesTo 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(s)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
Health condition(s) or problem(s) studiedAlcohol harm prevention delivered in the workplace
InterventionRandomisation
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 typeBehavioural
Primary outcome measureManagers' 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 measuresThe 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 study start date01/01/2018
Completion date31/12/2020

Eligibility

Participant type(s)Mixed
Age groupAdult
SexBoth
Target number of participants13 organisations (at least 100 participants in each cluster)
Total final enrolment1842
Key inclusion criteriaCluster 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
Key exclusion criteriaCluster 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
Date of first enrolment01/03/2018
Date of final enrolment30/09/2020

Locations

Countries of recruitment

  • Sweden

Study participating centre

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

Sponsor information

Stockholm University
University/education

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

Phone +46 8 16 20 00
Email mikael.rostila@su.se
ROR logo "ROR" https://ror.org/05f0yaq80

Funders

Funder type

Government

Folkhälsomyndigheten
Government organisation / National government
Alternative name(s)
Public Health Agency of Sweden
Location
Sweden

Results and Publications

Intention to publish date31/10/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in high-impact peer-reviewed journals and presentations at international conferences.
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 07/04/2020 07/04/2020 No No
Protocol article protocol 12/08/2020 17/08/2020 Yes No
Results article Managerial level results 17/07/2020 09/12/2020 Yes No
Basic results 10/12/2020 11/12/2020 No No
Basic results 12/01/2021 12/01/2021 No No
Results article Employee level results 24/07/2023 25/07/2023 Yes No
Results article 17/10/2022 18/11/2024 Yes No

Additional files

ISRCTN17250048_BasicResults_07April2020.pdf
Uploaded 07/04/2020
ISCRTN17250048_BasicResults_10Dec2020.pdf
uploaded 11/12/2020
ISRCTN17250048_BasicResults_12Jan2021.pdf
Uploaded 12/01/2021

Editorial Notes

18/11/2024: Publication reference added.
25/07/2023: Publication reference added.
12/01/2021: The updated basic results of this trial have been uploaded as an additional file. The total final enrolment number was added.
11/12/2020: The updated basic results of this trial have been uploaded as an additional file.
09/12/2020: Publication reference added.
17/08/2020: Publication reference added.
07/04/2020: The following changes have been made:
1. The basic results of this trial have been uploaded as an additional file.
2. The total final enrolment number has been added.
25/09/2019: Trial's existence confirmed by Stockholm Regional Ethics Board.