search
Back to results

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)

Primary Purpose

Alcohol Abuse, Episodic Drinking Behavior

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Brief Motivational Intervention (BMI)
Simple written advice
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Abuse, Episodic Drinking Behavior focused on measuring alcohol, hazardous or harmful drinking, emergency department (ED)

Eligibility Criteria

16 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rennes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Brief Motivational Intervention (BMI)

Arm Description

A simple written advice.

Brief Motivational Intervention (BMI)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

ED readmission
ED readmission
quarrels related to alcohol
quarrels related to alcohol
drinking and driving
drinking and driving
sexual intercourse without protection
sexual intercourse without protection

Full Information

First Posted
September 12, 2011
Last Updated
March 27, 2023
Sponsor
Rennes University Hospital
Collaborators
MAFEJ, AIRDDS-CIRDD, Observatoire Français des Drogues et des Toxicomanies (OFDT)
search

1. Study Identification

Unique Protocol Identification Number
NCT01435668
Brief Title
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
Acronym
AURAIA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
MAFEJ, AIRDDS-CIRDD, Observatoire Français des Drogues et des Toxicomanies (OFDT)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Episodic Drinking Behavior
Keywords
alcohol, hazardous or harmful drinking, emergency department (ED)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
A simple written advice.
Arm Title
Brief Motivational Intervention (BMI)
Arm Type
Experimental
Arm Description
Brief Motivational Intervention (BMI)
Intervention Type
Behavioral
Intervention Name(s)
Brief Motivational Intervention (BMI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Simple written advice
Intervention Description
Patients receive an information leaflet.
Primary Outcome Measure Information:
Title
alcohol use
Description
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 Outcome Measure Information:
Title
ED readmission
Description
ED readmission
Time Frame
3 months
Title
quarrels related to alcohol
Description
quarrels related to alcohol
Time Frame
3 months
Title
drinking and driving
Description
drinking and driving
Time Frame
3 months
Title
sexual intercourse without protection
Description
sexual intercourse without protection
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelhouahab BELLOU, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28704267
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs