Efficacy of ready4life: a digital addiction prevention program for young people

ISRCTN ISRCTN59908406
DOI https://doi.org/10.1186/ISRCTN59908406
Submission date
20/10/2020
Registration date
21/10/2020
Last edited
28/11/2022
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
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

Contact information

Dr Severin Haug
Scientific

Konradstrasse 32
Zurich
8005
Switzerland

ORCiD logoORCID ID 0000-0002-6539-5045
Phone +41444481174
Email severin.haug@isgf.uzh.ch

Study information

Study designInterventional two-arm single-blind cluster-randomized controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)School
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a participant information sheet.
Scientific titleEfficacy of a digital coaching program for addiction prevention among vocational school students: Study protocol of a cluster-randomised controlled trial
Study acronymready4life
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedPrevention of addictive behaviors in students
InterventionParticipants 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 typeBehavioural
Primary outcome measureAt 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 measuresAt 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 study start date01/08/2020
Completion date31/12/2022

Eligibility

Participant type(s)Healthy volunteer
Age groupOther
SexBoth
Target number of participantsn=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.
Total final enrolment1351
Key inclusion criteria1. Vocational school student
2. Minimum age 15
3. Possession of a smartphone
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/06/2021
Date of final enrolment31/05/2022

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Swiss Reseach Institute for Public Health and Addiction
Konradstrasse 32
Zurich
8005
Switzerland

Sponsor information

Swiss Research Institute for Public Health and Addiction
Research organisation

Konradstrasse 32
Zürich
8005
Switzerland

Phone +41 (0)44 448 11 65
Email michael.schaub@isgf.uzh.ch
Website https://www.isgf.uzh.ch

Funders

Funder type

Research organisation

Research Fund of the Swiss Lung Association

No information available

Results and Publications

Intention to publish date31/03/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planWe 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 planData available on request due to restrictions. The datasets generated and analyzed during the current study are not publicly available due to the Swiss data protection law but are available from the corresponding author (severin.haug@isgf.uzh.ch) on reasonable request. Requests will be reviewed for reasonability and compliance with the study purpose and the participants’ informed consent.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article 14/12/2020 18/08/2021 Yes No
Results article 25/11/2022 28/11/2022 Yes No

Editorial Notes

28/11/2022: Publication reference and total final enrolment added.
18/08/2021: Publication reference added.
21/10/2020: Trial’s existence confirmed by University of Zurich.