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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01435668
First Posted: September 16, 2011
Last Update Posted: January 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
MAFEJ
AIRDDS-CIRDD
Observatoire Français des Drogues et des Toxicomanies (OFDT)
Information provided by (Responsible Party):
Rennes University Hospital
  Purpose

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.


Condition Intervention
Alcohol Abuse, Episodic Drinking Behavior Behavioral: Brief Motivational Intervention (BMI) Behavioral: Simple written advice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • alcohol use [ Time Frame: 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. Others indicators such as binge drinking episodes and number of days drinking per week will also be assessed.


Secondary Outcome Measures:
  • ED readmission [ Time Frame: 3 months ]
    ED readmission

  • quarrels related to alcohol [ Time Frame: 3 months ]
    quarrels related to alcohol

  • drinking and driving [ Time Frame: 3 months ]
    drinking and driving

  • sexual intercourse without protection [ Time Frame: 3 months ]
    sexual intercourse without protection


Enrollment: 258
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
A simple written advice.
Behavioral: Simple written advice
Patients receive an information leaflet.
Experimental: Brief Motivational Intervention (BMI)
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435668


Locations
France
Rennes University Hospital
Rennes, Bretagne, France, 35033
Sponsors and Collaborators
Rennes University Hospital
MAFEJ
AIRDDS-CIRDD
Observatoire Français des Drogues et des Toxicomanies (OFDT)
Investigators
Principal Investigator: Abdelhouahab BELLOU, MD Rennes University Hospital
  More Information

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01435668     History of Changes
Other Study ID Numbers: LOC/11-01 - AURAIA
2011-A00017-34 ( Other Identifier: ID RCB )
11/06-795 ( Other Identifier: CPP Ouest V (Rennes) )
First Submitted: September 12, 2011
First Posted: September 16, 2011
Last Update Posted: January 6, 2014
Last Verified: January 2014

Keywords provided by Rennes University Hospital:
alcohol
hazardous or harmful drinking
emergency department (ED)

Additional relevant MeSH terms:
Emergencies
Alcoholism
Alcohol Drinking
Drinking Behavior
Disease Attributes
Pathologic Processes
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs