Plain English Summary
Background and study aims
A large proportion of apprentices shows addictive behaviors like cigarette smoking, alcohol-, cannabis- or compulsive internet use. Others do not show these behaviors and develop a low-risk handling of substances due to their resources and life skills. "ready4life" is a mobile phone-based addiction prevention program that takes into account the heterogeneity of adolescent addictive behavior by promoting life skills on the one hand and reducing risk behaviors on the other.
The main objective of the planned study is to test "ready4life" among vocational school students in Switzerland within a controlled trial.
Who can participate?
Vocational school students in Switzerland who own a smartphone
What does the study involve?
Participants of the intervention group will participate in the digital coaching program "ready4life". Based on their risk and resource profile, they can select two out of 6 program modules on stress, social skills, Internet use, tobacco, cannabis, and alcohol. They receive coaching for a period of four months by a conversational agent (chatbot). This virtual coach motivates the participants to deal sensitively with addictive substances, gives feedback on current use and provides information in weekly dialogues. In a separate chat within the app, the participants can pose personal questions to regional addiction prevention experts.
A total of 1,318 study participants will be recruited within vocational schools. A follow up assessment, focusing on the study participant's addictive behaviors, will be conducted in month 6, i.e., 2 months after the end of the program.
Participants of the assessment only control group will receive no intervention.
Participants in both groups will be asked to complete questionnaires relating to substance use, stress symptoms and self-efficacy at the beginning of the study as well as after 6 months.
What are the possible benefits and risks of participating?
The possible benefit to participants is that the intervention will improve their life skills and prevent addictive behaviors. There are no known risks to participants taking part in this study.
Where is the study run from?
Swiss Research Institute for Public Health and Addiction (Switzerland)
When is the study starting and how long is it expected to run for?
August 2020 to December 2022
Who is funding the study?
Research Fund of the Swiss Lung Association (Switzerland)
Who is the main contact?
Dr Severin Haug
severin.haug@isgf.uzh.ch
Trial website
Contact information
Type
Scientific
Primary contact
Dr Severin Haug
ORCID ID
http://orcid.org/0000-0002-6539-5045
Contact details
Konradstrasse 32
Zurich
8005
Switzerland
+41444481174
severin.haug@isgf.uzh.ch
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Efficacy of a digital coaching program for addiction prevention among vocational school students: Study protocol of a cluster-randomised controlled trial
Acronym
ready4life
Study hypothesis
The intervention program will be more effective than assessment only, to prevent the onset and escalation of addictive behaviors (at-risk alcohol use, tobacco use, cannabis use, and problematic Internet use) at 6-months follow-up.
Ethics approval
Approved 16/10/2020, Ethics Committee of the Faculty of Arts and Sciences at the University of Zurich (Binzmühlestrasse 14, Box 22, CH-8050 Zürich, Switzerland; +41 44 635 74 70; k.oberauer@psychologie.uzh.ch), ref: 20.10.12
Study design
Interventional two-arm single-blind cluster-randomized controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet.
Condition
Prevention of addictive behaviors in students
Intervention
Participants will be cluster-randomised, using school class as a randomisation unit. Due to the heterogeneity of students in the different vocational schools, we will use a separate randomisation list for each school (stratified randomisation). Furthermore, to approximate equality of sample sizes in the study groups, we will use block randomisation with computer-generated randomly permuted blocks of 4 cases. School classes will be randomised into two groups, an intervention and a control group. Research assistants supervising the baseline and follow-up assessments will be blinded to the group allocation of the participants.
Participants in the intervention group will participate in the digital prevention program "ready4life". Within this app-based program, an individual profile is generated on the basis of a survey conducted via smartphone. This profile shows areas in which a participant has sufficient resources and in which there is a need for coaching or counselling. Based on their risk and resource profile, the participants can select two out of the following 6 program modules: stress, social skills, Internet use, tobacco, cannabis, and alcohol. Participants of the intervention group will receive indivdualised coaching for a period of four months by a conversational agent (chatbot). This virtual coach motivates the participants to deal sensitively with addictive substances, gives feedback on current consumption and provides information in weekly dialogues. In a separate chat within the app, the participants can pose personal questions to regional addiction prevention experts. In order to achieve high engagement rates, interactive elements such as quiz questions, contests, and a playful competition are integrated into ready4life.
Participants in the control group will not participate in the intervention program.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
At baseline- and 6-months follow-up, measured by self-report:
A composite measure for addictive behaviors composed of:
1. At risk-drinking in the preceding 30 days, according to guidelines of the Swiss Federal Office of Public Health
2. 30-days point prevalence for tobacco/e-cigarette smoking
3. 30-days point prevalence for cannabis use
4. Problematic Internet use assessed by the Compulsive Internet Use Scale, CIUS
Secondary outcome measures
At baseline- and 6-months follow-up assessments:
1. General self-efficacy assessed by the Short Scale for Measuring General Self-efficacy Beliefs (ASKU)
2. Stress assessed by a single-item measure of stress symptoms
Overall trial start date
01/08/2020
Overall trial end date
31/12/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Vocational school student
2. Minimum age 15
3. Possession of a smartphone
Participant type
Healthy volunteer
Age group
Other
Gender
Both
Target number of participants
n=659 per study group and a total of n=1,318 study participants. Approximately 100 vocational school classes are required to reach this sample size.
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/06/2021
Recruitment end date
31/05/2022
Locations
Countries of recruitment
Switzerland
Trial participating centre
Swiss Reseach Institute for Public Health and Addiction
Konradstrasse 32
Zurich
8005
Switzerland
Sponsor information
Organisation
Swiss Research Institute for Public Health and Addiction
Sponsor details
Konradstrasse 32
Zürich
8005
Switzerland
+41 (0)44 448 11 65
michael.schaub@isgf.uzh.ch
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Research Fund of the Swiss Lung Association
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We intend to publish the study protocol in 2021, the outcomes and moderators of outcome in 2023. All results will be published in high impact peer reviewed medical or psychological journals.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.
Intention to publish date
31/03/2023
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list