Condition category
Not Applicable
Date applied
09/03/2016
Date assigned
10/03/2016
Last edited
19/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
One fifth of drivers convicted of drink-driving for the first time will be convicted again for the same offence in subsequent years. Lecture-based educational programs are believed to reduce recidivism (re-offending). The aim of this study is to measure the effects of short lectures with and without the presence of a close relative ‘in class’ on the rates of recidivism during the two years after an initial drink-driving conviction.

Who can participate?
Drivers in the Canton of Geneva convicted of a first-time drink-driving offence.

What does the study involve?
Participants are randomly allocated to attend either: a two-hour series of lectures; a one-hour lecture and a group psychological intervention with a close relative; or to receive written information on the consequences of alcohol consumption. Time until recidivism is retrieved from a national registry for two years after participation.

What are the possible benefits and risks of participating?
Participants benefit from a one-month reduction of the time for which their license is suspended. They will also personally benefit from changing their behaviour towards drink driving given the legal, financial and emotional consequences drink driving can have. There are no known risks related to the intervention.

Where is the study run from?
University Center of Legal Medicine Lausanne-Geneva (Switzerland)

When is the study starting and how long is it expected to run for?
December 2011 to July 2016

Who is funding the study?
Swiss Federal Office for Roads (Switzerland)

Who is the main contact?
Prof Paul Vaucher

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul Vaucher

ORCID ID

http://orcid.org/0000-0002-0652-0985

Contact details

School of Health Sciences Fribourg
University of Applied Sciences and Arts Western Switzerland (HES-SO)
Rue des Cliniques 15
Fribourg
1700
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CER10-214

Study information

Scientific title

Effectiveness of an educational program for preventing drinking and driving recidivism: a randomized controlled trial

Acronym

PRECASIA 2

Study hypothesis

A short educational program with or without a proxy reduces the hazard of drink driving recidivism within the two first years.

Ethics approval

Official state ethical committee (Commission cantonale d'éthique de la recherche du Canton de Genève), December 2010, ref: CER10-214

Study design

Single-centre three-armed parallel randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

See additional files

Condition

First time convicted offenders for drink driving with blood alcohol concentration ≥0.8 g/kg and < to 2.5 g/kg

Intervention

Participants are invited to attend an educational programme on drinking and driving in exchange for a reduction, of one month, of the time for which their license is suspended.

Participants are randomly assigned to either:
1. A two-hour series of lectures. Participants are informed regarding accident statistics, offence-related legal procedures, the consequences of DUI for insurance cover, the medical consequences of heavy drinking, the psychological aspects of alcohol consumption, and behavioural strategies for avoiding DUI recidivism. Class size are limited to 12 participants. Participants receive printed materials on alcohol consumption and consequences at the end of the two-hour lecture. The program is delivered by a psychologist with educational experience. The entire lecture is delivered during one morning.
2. A one-hour lecture and a group psychological intervention with a proxy. Participants are asked to choose, nominate, and bring with them a close relation (proxy) such as their spouse, a companion, or a friend. After receiving a briefer lecture, this group is to expose reasons for changes to an unknown proxy from another pair. They then have to plan a strategy for change with their original proxy.
3. The control group also receive a reduction, of one month, of the time for which their license is suspended and paid for program costs. They however only received written information on alcohol consumption and consequences.

Program costs were paid by the individual drivers (CHF 200).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Time till drink driving recidivism offense with blood alcohol concentration (BAC) ≥0.8 g/kg, retrieved from a national registry that contains details of recidivism that take place up to two years after inclusion.

Secondary outcome measures

None

Overall trial start date

01/12/2011

Overall trial end date

31/07/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Over 18 years of age
2. Having one’s driving license suspended for DUI offense
3. Understanding French
4. Being able to read and write
5. Having a potential proxy to attend the course with

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

600 (200 per group)

Participant exclusion criteria

BAC ≥2.5 g/kg

Recruitment start date

01/12/2011

Recruitment end date

30/06/2014

Locations

Countries of recruitment

Switzerland

Trial participating centre

University Center of Legal Medicine Lausanne-Geneva, Geneva
Rue Jean-Violette 32
Geneva
1205
Switzerland

Sponsor information

Organisation

Geneva University Hospitals, University Centre of Legal Medicine

Sponsor details

Rue Gabrielle-Perret-Gentil 4
Geneva
1211
Switzerland

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Swiss Federal Office for Roads (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results are to be published during the first semester of 2017.

Intention to publish date

12/12/2016

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/04/2016: Participant Information Sheet uploaded.