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 (AURAIA)

Impact Evaluation at 3 Months Follow-up of a Brief Motivational Intervention in Reducing Alcohol Consumption Versus Simple Written Advice Only Among Adolescents Aged 16-24 in Pontchaillou Hospital Emergency Department in Rennes, France

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Abuse, Episodic Drinking Behavior
• Intervention / Treatment: Behavioral: Simple written advice; Behavioral: Brief Motivational Intervention (BMI)

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.

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Rennes, Bretagne, France, 35033
      • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; A simple written advice.	Behavioral: Simple written advice; Patients receive an information leaflet.
Experimental: Brief Motivational Intervention (BMI)	Behavioral: Brief 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ED readmission	ED readmission	3 months
quarrels related to alcohol	quarrels related to alcohol	3 months
drinking and driving	drinking and driving	3 months
sexual intercourse without protection	sexual intercourse without protection	3 months

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: MAFEJ; AIRDDS-CIRDD; Observatoire Français des Drogues et des Toxicomanies (OFDT)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 12, 2011
• First Submitted That Met QC Criteria: September 15, 2011
• First Posted (Estimate): September 16, 2011

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: alcohol; emergency department (ED); hazardous or harmful drinking
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Disease Attributes; Alcohol Drinking; Alcoholism; Emergencies; Drinking Behavior
• Other Study ID Numbers: LOC/11-01 - AURAIA; 2011-A00017-34 (Other Identifier: ID RCB); 11/06-795 (Other Identifier: CPP Ouest V (Rennes))