Alcohol Abuse, Episodic Drinking BehaviorAURAIANCT01435668
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
A study testing Brief Motivational Intervention (BMI) and Simple written advice in people with Alcohol Abuse, Episodic Drinking Behavior, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Alcohol Abuse, Episodic Drinking Behavior
- What is being tested?
- Brief Motivational Intervention (BMI) and Simple written advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- Brief Motivational Intervention (BMI), Simple written advice
- Keywords
- alcohol, hazardous or harmful drinking, emergency department (ED)
- Medical subject headings
- Alcoholism, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational Intervention (BMI)Behavioural
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.
Simple written adviceBehavioural
Patients receive an information leaflet.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | A simple written advice. Receives: Behavioral: Simple written advice |
| Brief Motivational Intervention (BMI) | Experimental | Brief Motivational Intervention (BMI) Receives: Behavioral: Brief Motivational Intervention (BMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
ED readmission
ED readmission
Measured: 3 months
quarrels related to alcohol
quarrels related to alcohol
Measured: 3 months
drinking and driving
drinking and driving
Measured: 3 months
sexual intercourse without protection
sexual intercourse without protection
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Abuse, Episodic Drinking BehaviorStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MAFEJ, AIRDDS-CIRDD, Observatoire Français des Drogues et des Toxicomanies (OFDT)
- Responsible party
- Sponsor
- Investigators
- Abdelhouahab BELLOU, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435668
- Sponsor's protocol ID
- LOC/11-01 - AURAIA
- Other IDs
- 2011-A00017-34, 11/06-795
- Acronym
- AURAIA
- Status last verified
- Jan 2014
- First submitted
- 12 Sep 2011
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28704267
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01435668
- Acronym / sponsor ID
- AURAIA / LOC/11-01 - AURAIA
- Keywords
- alcohol, hazardous or harmful drinking, emergency department (ED)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- MAFEJ, AIRDDS-CIRDD, Observatoire Français des Drogues et des Toxicomanies (OFDT)
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Behavioral: Simple written adviceA simple written advice. |
| Brief Motivational Intervention (BMI) | Experimental | Behavioral: Brief Motivational Intervention (BMI)Brief Motivational Intervention (BMI) |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Brief Motivational Intervention (BMI) |
| Simple written advicePatients receive an information leaflet. | Behavioural | Control |
Primary outcome
alcohol use
Time frame: 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.
4 secondary outcomes
ED readmission
Time frame: 3 months
quarrels related to alcohol
Time frame: 3 months
drinking and driving
Time frame: 3 months
sexual intercourse without protection
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Results publication: PubMed 28704267Diaz 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.
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdelhouahab BELLOU, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Intervention (BMI) and Simple written advice in people with Alcohol Abuse, Episodic Drinking Behavior, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alcohol use (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01435668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.