ESAS: Electronic study on alcohol among students
| ISRCTN | ISRCTN10007691 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10007691 |
| Secondary identifying numbers | Swiss National Science Fondation 176295 |
- Submission date
- 02/12/2019
- Registration date
- 05/12/2019
- Last edited
- 07/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Unhealthy alcohol use is a major morbidity and mortality risk factor among students. Electronic screening and brief interventions have the potential to limit drinking and its consequences by reaching large parts of the population that do not necessarily access care. Computer or internet-based interventions targeting unhealthy alcohol use have shown promising results, but efficacy is limited. Smartphones offer an opportunity for interventions with multiple contacts at the user’s convenience, which may increase interventions’ efficacy. Smartphone applications also allow delivering interventions in context outside of reach of face-to-face or computerized intervention, including in situations in which people are drinking alcohol, for example at parties. Evidence of efficacy of computer or internet-based interventions cannot be extrapolated to smartphone applications: computers and smartphones are used differently, which may change their impact. Research is only starting in this area and efficacy of smartphone applications is largely unknown.
Aim: This project proposes a mixed methods approach to develop and test the efficacy of a smartphone application aimed at decreasing unhealthy alcohol use in students.
Who can participate?
Registered students aged 18 years or older, studying at one of the participating Schools/Universities (French part of Switzerland) who screen positive for unhealthy alcohol use.
What does the study involve?
Participating in 4 assessments over a 12 months period
Participants may be given access to a smartphone app with prevention material
What are the possible benefits and risks of participating?
There may be no direct benefit to participants. Potential benefits to participants include the possibility to reduce alcohol consumption and related problems; participants also may benefit from assessments and monitoring of alcohol use. They might take advantage of study participation to think about their behavior and life values and better know themselves.
The risks of serious adverse consequences as a result of study participation are relatively low. Participants might have concerns about confidentiality of sensitive information reported during the study assessments. The sensitive nature of some of the questions (e.g., alcohol-related) may cause participants discomfort.
Where is the study run from?
Lausanne University Hospital and University of Lausanne, Switzerland
When is the study starting and how long is it expected to run for?
April 2020 to June 2022
Who is funding the study?
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (Swiss National Science Foundation)
Who is the main contact?
Dr Nicolas Bertholet
Nicolas.Bertholet@chuv.ch
Contact information
Scientific
Lausanne University Hospital
Addiction Medicine
Bugnon 23A
Lausanne
1011
Switzerland
 ORCID ID |
0000-0001-5064-6377 |
|---|---|
| Phone | +41213140327 |
| Nicolas.Bertholet@chuv.ch |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Smartphone-based secondary prevention intervention for students with unhealthy alcohol use: qualitative study and randomized controlled trial |
| Study acronym | ESAS |
| Study objectives | Participants in the intervention group (experimental condition: secondary prevention intervention delivered via a smartphone application) will report a smaller volume of drinking (measured with the mean number of drinks per week consumed over the past 30 days) at the 6-month follow-up compared to participants in the control group (receiving electronic assessment only). |
| Ethics approval(s) | Approved 25/05/2018, Commission cantonale (VD) d'éthique de la recherche sur l'être humain (CER-VD) (Ethics committee of the Canton de Vaud, Avenue de Chailly 23, 1012 Lausanne, Switzerland; +41 21 316 18 30; secretariat.cer@vd.ch), ref: 2018-00560 |
| Health condition(s) or problem(s) studied | Unhealthy alcohol use |
| Intervention | Qualitative study: a member of the target population (i.e. fulfilling the randomized trial inclusion criteria) will be recruited to download and test a prototype of the smartphone-based intervention. After providing written informed consent, participants (n=20) are taking part in two rounds of qualitative assessments (individual semi-structured interviews). The smartphone-based intervention is modified after each round. An interview grid was developed for the project. All interviews are audio-recorded and transcribed verbatim. A conventional content analysis is conducted. Phase I, development of the smartphone application and qualitative assessment: the piloted smartphone application will be further developed, notably to send messages to participants following pre-specified scenarios based on application usage. Modifications will be done in an iterative process. Two rounds of qualitative assessments (individual semi-structured interviews and focus group) will be conducted among members of the study population. Each round will lead to modifications in the smartphone application. Phase II, randomized controlled trial: the application’s efficacy will be tested in a two parallel-group randomized controlled trial with a 1:1 allocation ratio with follow-up assessments at 3, 6 and 12 months. Control (assessment only) Intervention (assessment + smartphone application). The entire randomized trial will be conducted electronically. Randomization is embedded within study website with full concealment of allocation. Electronic assessments at follow-up (3, 6, 12 months post baseline) Intervention: providing access to a secondary prevention intervention targeting unhealthy alcohol use, delivered via a smartphone application |
| Intervention type | Other |
| Primary outcome measure | Mean number of drinks per week over the past 30 days (electronic self-report), measured at 6 months |
| Secondary outcome measures | All electronic self-report, measured at 6 months: 1. Number of heavy drinking days over the past 30 days 2. Additional outcomes will be: maximum number of drinks on any day over the past 30 days, alcohol related consequences (measured with the Short Inventory of Problems (SIP-2R), and academic performance |
| Overall study start date | 30/03/2017 |
| Completion date | 12/06/2022 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1,696 |
| Total final enrolment | 1770 |
| Key inclusion criteria | 1. Registered student at one of the participating Schools/Universities (French part of Switzerland) 2. Age 18 years and over 3. Positive screen for unhealthy alcohol use 4. Smartphone ownership 5. Willingness to complete follow-up assessments |
| Key exclusion criteria | 1. Students who participated in the development of the smartphone application |
| Date of first enrolment | 26/04/2021 |
| Date of final enrolment | 28/04/2021 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Bugnon 23A
Lausanne
1011
Switzerland
Sponsor information
Hospital/treatment centre
Addiction Medicine
Lausanne
1011
Switzerland
| Phone | +41213148400 |
|---|---|
| info@chuv.ch | |
| Website | http://www.chuv.ch |
"ROR" |
https://ror.org/05a353079 |
Funders
Funder type
Government
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
Results and Publications
| Intention to publish date | 31/08/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Results will be presented at international conference and published in peer reviewed journals. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/02/2020 | 24/02/2020 | Yes | No |
| Other publications | qualitative outcome data on the app development process | 07/03/2023 | 08/03/2023 | Yes | No |
| Results article | 16/08/2023 | 17/08/2023 | Yes | No | |
| Other publications | Secondary mediation analysis | 06/02/2025 | 07/02/2025 | Yes | No |
Editorial Notes
07/02/2025: Publication reference added.
17/08/2023: Publication reference added.
25/07/2023: The intention to publish date was changed from 30/06/2022 to 31/08/2023.
08/03/2023: Publication reference added.
15/06/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/06/2022 to 12/06/2022.
2. The total final enrolment was changed from 1696 to 1770.
28/04/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2021 to 28/04/2021.
2. The total final enrolment number has been added.
30/03/2021: The recruitment start date has been changed from 01/02/2021 to 26/04/2021.
24/11/2020: The recruitment start date was changed from 01/11/2020 to.
31/07/2020: The recruitment start date has been changed from 01/09/2020 to 01/11/2020.
09/04/2020: The recruitment start date has been changed from 01/04/2020 to 01/09/2020.
24/02/2020: Publication reference added.
03/12/2019: Trial’s existence confirmed by Commission cantonale (VD) d'éthique de la recherche sur l'être humain (CER-VD) (Ethics committee of the Canton de Vaud, Switzerland)
