Condition category
Mental and Behavioural Disorders
Date applied
20/10/2020
Date assigned
21/10/2020
Last edited
21/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

https://www.isgf.uzh.ch

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

Publication citations

Additional files

Editorial Notes

21/10/2020: Trial’s existence confirmed by University of Zurich.