Clinical trial NCT01435668: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse, Episodic Drinking Behavior
Keywords: alcohol
hazardous or harmful drinking
emergency department (ED)
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: MAFEJ
name: AIRDDS-CIRDD
name: Observatoire Français des Drogues et des Toxicomanies (OFDT)
First posted: 2011-09-16
Enrollment: 258
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: alcohol use
timeFrame: 3 months
Secondary outcomes:
measure: ED readmission
timeFrame: 3 months
measure: quarrels related to alcohol
timeFrame: 3 months
measure: drinking and driving
timeFrame: 3 months
measure: sexual intercourse without protection
timeFrame: 3 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Bretagne
Study officials:
affiliation: Rennes University Hospital
name: Abdelhouahab BELLOU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.