Alcohol Abuse, Episodic Drinking Behavior Clinical Trial
— AURAIAOfficial 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
| Verified date | January 2014 |
| Source | Rennes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 258 |
| Est. completion date | December 2012 |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 24 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Rennes University Hospital | Rennes | Bretagne |
| Lead Sponsor | Collaborator |
|---|---|
| Rennes University Hospital | AIRDDS-CIRDD, MAFEJ, Observatoire Français des Drogues et des Toxicomanies (OFDT) |
France,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | alcohol use | 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. | 3 months | |
| Secondary | ED readmission | ED readmission | 3 months | |
| Secondary | quarrels related to alcohol | quarrels related to alcohol | 3 months | |
| Secondary | drinking and driving | drinking and driving | 3 months | |
| Secondary | sexual intercourse without protection | sexual intercourse without protection | 3 months |