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
  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 Blind (Subject)
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 ] [ 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.


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   16 Years to 24 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01435668     History of Changes
Other Study ID Numbers: LOC/11-01 - AURAIA, 2011-A00017-34, 11/06-795
Study First Received: September 12, 2011
Last Updated: January 3, 2014
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Committee for the Protection of Personnes
France: The Commission nationale de l’informatique et des libertés

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

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Emergencies
Alcoholism
Disease Attributes
Pathologic Processes
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014