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
3 other identifiers
interventional
258
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 12, 2011
CompletedFirst Posted
Study publicly available on registry
September 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMarch 30, 2023
January 1, 2014
1.2 years
September 12, 2011
March 27, 2023
Conditions
Keywords
Outcome Measures
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.
3 months
Secondary Outcomes (4)
ED readmission
3 months
quarrels related to alcohol
3 months
drinking and driving
3 months
sexual intercourse without protection
3 months
Study Arms (2)
Control
OTHERA simple written advice.
Brief Motivational Intervention (BMI)
EXPERIMENTALBrief Motivational Intervention (BMI)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rennes University Hospitallead
- MAFEJcollaborator
- AIRDDS-CIRDDcollaborator
- Observatoire Français des Drogues et des Toxicomanies (OFDT)collaborator
Study Sites (1)
Rennes University Hospital
Rennes, Brittany Region, 35033, France
Related Publications (1)
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.
PMID: 28704267RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abdelhouahab BELLOU, MD
Rennes University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2011
First Posted
September 16, 2011
Study Start
September 1, 2011
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
March 30, 2023
Record last verified: 2014-01