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

This study has been completed.
Sponsor:
Collaborators:
MAFEJ
AIRDDS-CIRDD
Observatoire Français des Drogues et des Toxicomanies (OFDT)
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01435668
First received: September 12, 2011
Last updated: January 3, 2014
Last verified: January 2014

September 12, 2011
January 3, 2014
September 2011
November 2012   (final data collection date for primary outcome measure)
alcohol use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01435668 on ClinicalTrials.gov Archive Site
  • ED readmission [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    ED readmission
  • quarrels related to alcohol [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    quarrels related to alcohol
  • drinking and driving [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    drinking and driving
  • sexual intercourse without protection [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    sexual intercourse without protection
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Alcohol Abuse, Episodic Drinking Behavior
  • 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.
  • Behavioral: Simple written advice
    Patients receive an information leaflet.
  • Control
    A simple written advice.
    Intervention: Behavioral: Simple written advice
  • Experimental: Brief Motivational Intervention (BMI)
    Brief Motivational Intervention (BMI)
    Intervention: Behavioral: Brief Motivational Intervention (BMI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
258
December 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
16 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01435668
LOC/11-01 - AURAIA, 2011-A00017-34, 11/06-795
No
Rennes University Hospital
Rennes University Hospital
  • MAFEJ
  • AIRDDS-CIRDD
  • Observatoire Français des Drogues et des Toxicomanies (OFDT)
Principal Investigator: Abdelhouahab BELLOU, MD Rennes University Hospital
Rennes University Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP