Just-in-time delivered planning intervention to reduce alcohol use in adolescents

ISRCTN	ISRCTN52150713
DOI	https://doi.org/10.1186/ISRCTN52150713
Secondary identifying numbers	17.4.11

Submission date: 31/05/2017
Registration date: 02/06/2017
Last edited: 27/05/2020

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

Background and study aims
Interventions to reduce alcohol use typically include several elements such as information on the risks of alcohol consumption, motivation for sensible drinking, or strategies to resist drinking in certain situations. However, the effectiveness of these single intervention elements within comprehensive programs has not been addressed so far, but could give valuable insights for the development of future interventions. Just-in-time interventions provided via mobile devices (i.e., text messages) are intended to help people to make healthy decisions “in the moment”, and thus have a near-future impact. The aim of this study is to test the impact of such just-in-time delivered interventions on alcohol use and binge drinking.

Who can participate?
Adolescents aged 16 or over who binge drink (i.e., who have drunk 4 (female)/5 (male) or more alcoholic drinks on one or more occasion in the last 30 days)

What does the study involve?
On two of their typically indicated drinking days at 5pm, participants are randomly allocated to receive either:
1. An intervention including two text messages: one text message where they choose one of two predetermined if-then plans to practice sensible drinking, and another text message prompt to visualize the chosen plan
2. No intervention
The number of alcoholic drinks they consume in the evening/night is assessed by another text message at 5pm on the following day.

What are the possible benefits and risks of participating?
Alcohol use may be lower after receiving the sensible drinking text message. No risks of participation are expected.

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?
January 2017 to December 2018

Who is funding the study?
1. Swiss Research Institute for Public Health and Addiction (Switzerland)
2. Swiss Federal Office of Public Health (Switzerland)

Who is the main contact?
Dr Severin Haug
severin.haug@isgf.uzh.ch

Contact information

Dr Severin Haug
Scientific

Konradstrasse 32
Zurich
8031
Switzerland

ORCID ID	0000-0002-6539-5045
Phone	+41 (0)44 448 11 74
Email	severin.haug@isgf.uzh.ch

Study information

Study design	Micro-randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Home
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Efficacy of a just-in-time delivered planning intervention to reduce alcohol use in adolescents with hazardous alcohol consumption: a micro-randomized controlled trial
Study hypothesis	1. Alcohol use on the evening/night will be lower at points in time with digital micro intervention compared to assessment only 2. Binge drinking prevalence on the evening/night will be lower at points in time with digital micro intervention compared to assessment only
Ethics approval(s)	Ethics committee of the Faculty of Philosophy at the University of Zurich, 18/04/2017, ref: 17.4.11
Condition	Alcohol prevention
Intervention	Participants receive the just-in-time delivered planning intervention to reduce alcohol use on their typically indicated drinking day at 5pm. The study has an AB/BA crossover design, in which each participant receives the intervention and the control in a randomized order. The randomization sequence will be created using computerized random numbers. There is a period of at least 2 weeks between the intervention and control. Intervention points in time include: 1. Assessment of state of receptivity and state of vulnerability via SMS text message question (“Are you planning to go out or meet with friend this evening?”) on the typical individually indicated drinking day at 5pm 2. Confirmation of receptivity and vulnerability by a text message reply (“Yes”) from the participant 3. The digital micro intervention where participants can choose one of two predetermined if-then plans to practice sensible drinking via SMS text messaging and another text message prompt to visualize the chosen plan Control points in time only include 1 and 2. Follow-up assessments will be conducted 24 hours after the assessment of state of receptivity and vulnerability in both intervention and control points in time.
Intervention type	Behavioural
Primary outcome measure	Number of alcoholic standard drinks consumed during the previous evening/night, measured via an SMS text message "How many alcoholic drinks did you have last evening/night?” at 24 hours after the assessment of state of receptivity and vulnerability (i.e., at 5pm the following day)
Secondary outcome measures	Binge drinking: consumption of 5 (male) or 4 (female) or more alcoholic standard drinks during the previous evening/night, measured via an SMS text message "How many alcoholic drinks did you have last evening/night?” at 24 hours after the assessment of state of receptivity and vulnerability (i.e., at 5pm the following day)
Overall study start date	01/01/2017
Overall study end date	31/12/2018

Eligibility

Participant type(s)	Healthy volunteer
Age group	Mixed
Sex	Both
Target number of participants	79
Total final enrolment	136
Participant inclusion criteria	1. Ownership of a mobile phone 2. Hazardous alcohol use defined by binge drinking: consumption of 5 (male; female: 4) or more alcoholic standard drinks on one or more occasions within 30 days preceding the baseline assessment 3. Aged 16 or over
Participant exclusion criteria	1. No alcohol consumption with friends or when going out in the evening 2. Typical drinking time with friends or when going out: in the morning or afternoon 3. Age < 16
Recruitment start date	22/06/2017
Recruitment end date	31/10/2018

Locations

Countries of recruitment

Switzerland

Study participating centre

Swiss Research Institute for Public Health and Addiction

Zurich
8031
Switzerland

Sponsor information

Swiss Reseach Institute for Public Health and Addiction
University/education

Konradstrasse 32
Zurich
8031
Switzerland

Website	www.isgf.ch
"ROR"	https://ror.org/02crff812

Funders

Funder type

University/education

Swiss Research Institute for Public Health and Addiction

No information available

Swiss Federal Office of Public Health

No information available

Results and Publications

Intention to publish date	31/12/2019
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a psychological or medical peer reviewed journal around one year after the overall trial end date.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Severin Haug (severin.haug@isgf.uzh.ch).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/05/2020	27/05/2020	Yes	No

Editorial Notes

27/05/2020: Publication reference and total final enrolment number added.