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
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
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
NCT ID
NCT01435668
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)
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
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