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

NCT ID: NCT01435668

Last Updated: 2023-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alcohol Abuse, Episodic Drinking Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

A simple written advice.

Group Type OTHER

Simple written advice

Intervention Type BEHAVIORAL

Patients receive an information leaflet.

Brief Motivational Intervention (BMI)

Brief Motivational Intervention (BMI)

Group Type EXPERIMENTAL

Brief Motivational Intervention (BMI)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Simple written advice

Patients receive an information leaflet.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MAFEJ

UNKNOWN

Sponsor Role collaborator

AIRDDS-CIRDD

UNKNOWN

Sponsor Role collaborator

Observatoire Français des Drogues et des Toxicomanies (OFDT)

UNKNOWN

Sponsor Role collaborator

Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abdelhouahab BELLOU, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

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Rennes University Hospital

Rennes, Brittany Region, France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 28704267 (View on PubMed)

Other Identifiers

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2011-A00017-34

Identifier Type: OTHER

Identifier Source: secondary_id

11/06-795

Identifier Type: OTHER

Identifier Source: secondary_id

LOC/11-01 - AURAIA

Identifier Type: -

Identifier Source: org_study_id

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