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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- alcohol use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Brief Motivational Intervention (BMI)
Brief Motivational Intervention (BMI)
干预措施: Brief Motivational Intervention (BMI) (Behavioral)
Control
A simple written advice.
干预措施: Simple written advice (Behavioral)
结局指标
主要结局
alcohol use
时间窗: 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.
次要结局
- quarrels related to alcohol(3 months)
- sexual intercourse without protection(3 months)
- ED readmission(3 months)
- drinking and driving(3 months)