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

Sponsor

Rennes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01435668

Collaborator

MAFEJ (Other), AIRDDS-CIRDD (Other), Observatoire Français des Drogues et des Toxicomanies (OFDT) (Other)

258

Enrollment

Location

Arms

Duration (Months)

17.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Abuse, Episodic Drinking Behavior	Behavioral: Brief Motivational Intervention (BMI) Behavioral: Simple written advice	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

258 participants

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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

alcohol use [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 [3 months]
ED readmission
quarrels related to alcohol [3 months]
quarrels related to alcohol
drinking and driving [3 months]
drinking and driving
sexual intercourse without protection [3 months]
sexual intercourse without protection

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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