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CompletedNCT01435668AURAIAUpdated Mar 30, 2023

AURAIA Study : Impact Evaluation at 3 Months Follow-up of a Brief Motivational Intervention in Reducing Alcohol Consumption Among Adolescents Aged 16-24 in Pontchaillou Hospital Emergency Department in Rennes, France

An interventional study of Brief Motivational Intervention (BMI) and Simple written advice in Alcohol Abuse, Episodic Drinking Behavior, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 16 Years to 24 Years. Per ClinicalTrials.gov, last updated 2023-03-30.

Sponsored by Rennes University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
258
Allocation
Randomized
Ages
16 Years to 24 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the effectiveness of a Brief Motivational Intervention (BMI), in reducing alcohol consumption among patients with hazardous or harmful drinking admitted in emergency department (ED). Patients aged 16 to 24 and who tested positive for blood alcohol content (BAC) of 0.5g/l. or above are enrolled.

Patients receive either an information leaflet or an information leaflet plus a referral to a psychologist. BMI is provided by the psychologist. BMI consists in a first face-to-face interview (35-45 minutes) plus a telephone interview, at 1 and 2 months. Minors' parents are also invited to attend the BMI session. If necessary, patients can be referred to relevant care and treatment services for alcohol misuse.

In a simple blind, randomised controlled clinical trial of 280 patients, 140 patients are allocated to the treatment group and 140 to the control group. Randomisation is stratified according to patient's age (16-17 or 18-24). Opaque and sealed randomized envelops are used for randomisation.

Alcohol consumption is measured by self-report at 3 months. The principal criteria used to assess the reduction of alcohol use at 3 months follow-up is the number of alcoholic drinks in the last week. Other events such as ED readmission, quarrels related to alcohol, drinking and driving, sexual intercourse without protection will also be assessed. It is the first clinical trial in France comparing these two interventions among young patients in ED with this design.

Read the detailed description

Eligible patients are recruited by ED physicians. Staff in ED involved in the study is provided with a teaching session on the importance of alcohol misuse and inclusion procedures. Prior to enrolment, a written informed consent is requested from every patient. For patients under 18, a consent form is also requested from parent(s) or the legal tutor.

02

Conditions studied

  • Alcohol Abuse, Episodic Drinking Behavior

Keywords

  • alcohol
  • hazardous or harmful drinking
  • emergency department (ED)
03

In context

Alcoholism

1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.

This study's enrollment of 258 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men or women aged 16-24 attending ED services between Thursday 10 pm and Sunday 8 am
  • Breathalyzer test with a blood alcohol content (BAC) of 0.5g/l or above
  • Ability to give consent
  • Parental or legal tutor's consent is requested for patients under 18

Exclusion criteria

Exclusion Criteria:

  • Already enrolled in the study
  • Current ED visit for attempted suicide patients
  • Current ED visit for injured trauma patients
  • Alcohol dependence requiring hospitalisation or referral to local treatment
  • Current enrolment or request to enrol in substance abuse treatment program
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
258 participants (actual)

Study arms

  • Other
    Control

    A simple written advice.

    Behavioral: Simple written advice

  • Experimental
    Brief Motivational Intervention (BMI)

    Brief Motivational Intervention (BMI)

    Behavioral: Brief Motivational Intervention (BMI)

Interventions

  • BehavioralBrief Motivational Intervention (BMI)

    Patients receive an information leaflet plus a referral to a psychologiste. BMI is provided by the psychologist. BMI consists in a first face-to-face interview (35-45 minutes) plus a telephone interview, at 1 and 2 months. Minors' parents are also invited to attend the BMI session.

  • BehavioralSimple written advice

    Patients receive an information leaflet.

06

What researchers measure

Primary outcomes

  1. alcohol use

    The principal criteria used to assess the reduction of alcohol use at 3 months follow-up is the number of alcoholic drinks in the last week. Others indicators such as binge drinking episodes and number of days drinking per week will also be assessed.

    Time frame: 3 months

Secondary outcomes

  1. ED readmission

    ED readmission

    Time frame: 3 months

  2. quarrels related to alcohol

    quarrels related to alcohol

    Time frame: 3 months

  3. drinking and driving

    drinking and driving

    Time frame: 3 months

  4. sexual intercourse without protection

    sexual intercourse without protection

    Time frame: 3 months

07

Study locations

1 site
  • Rennes University Hospital
    Rennes, Bretagne 35033, France
08

References and documents

Publications

  • Diaz Gomez C, Ngantcha M, Le Garjean N, Brouard N, Lasbleiz M, Perennes M, Kerdiles FJ, Le Lan C, Moirand R, Bellou A. Effect of a brief motivational intervention in reducing alcohol consumption in the emergency department: a randomized controlled trial. Eur J Emerg Med. 2019 Feb;26(1):59-64. doi: 10.1097/MEJ.0000000000000488. PubMed 28704267 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01435668
Collaborators
MAFEJ, AIRDDS-CIRDD, Observatoire Français des Drogues et des Toxicomanies (OFDT)
Responsible party
Sponsor
First posted
Sep 16, 2011
Start date
Sep 2011
Primary completion
Nov 2012
Completion
Dec 2012
Last update
Mar 30, 2023

Study contacts

Abdelhouahab BELLOU, MD
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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