Behavioral Economic and Wellness-based Approaches for Reducing Alcohol Use and Consequences Among Diverse Non-student Emerging Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 525
- 试验地点
- 2
- 主要终点
- Change from Baseline Alcohol Consumption and Drug Use at 1-month
研究概览
简要总结
The purpose of this study is to evaluate an intervention approach for non-student emerging adults that attempts to reduce alcohol use by decreasing stress and increasing engagement in positive and goal-directed activities that provide meaningful alternatives to alcohol use.
详细描述
Brief alcohol interventions (BAI) are among the most cost-effective preventive care measures available and the evaluation of these interventions with high-risk and difficult-to-reach populations is an NIAAA priority. Although emerging adults (EAs) who attend college often have access to brief alcohol interventions (BAIs), there is a critical need to enhance both the efficacy and potential for dissemination of these approaches with high-risk non-student EAs. EAs who are not 4-year college students or graduates report higher levels of alcohol-related problems, greater levels of comorbid drug use and mental health symptoms, and higher risk for chronic alcohol use disorder compared to college graduates. Most BAIs include a single session focused explicitly on discussing risks associated with drinking and correcting normative beliefs about drinking rates without addressing the reasons why EAs may drink, including stress and limited behavioral alternatives to drinking. Because many EAs who do not graduate from college are socially and economically marginalized, an approach that encourages them to drink less without providing the tools to reduce stress and develop mood enhancing behavioral substitutes to drinking or drug use is unlikely to be successful. The Substance-Free Activity Session (SFAS) attempts to increase engagement goal-directed activities that might provide alternatives to alcohol use and also includes strategies for coping with stress/depression. The two-session (plus booster) BAI+SFAS approach has demonstrated efficacy for reducing both alcohol use/problems and depressive symptoms in two randomized clinical trials with college EAs and may be a more promising approach than single-session BAIs for higher-risk non-student EAs. Two critical next steps are to: 1) evaluate the BAI+SFAS with non-student EAs, and 2) determine if a two-session Relaxation Training (RT) +SFAS approach, which would enhance wellness and address two synergistic risk factors for alcohol misuse, demonstrates similar efficacy as the BAI+SFAS intervention. If so, this wellness-based approach may have greater potential for dissemination than approaches that include a BAI because the session content may be more appealing to EAs (managing stress and increasing positive activities). Thus, the primary goal of the proposed study is to establish the efficacy of these novel BAI approaches with high-risk community dwelling EAs, and a secondary goal is to identify factors that may increase potential for dissemination. We will conduct a randomized 3-group (BAI+SFAS vs. RT+SFAS vs. education control) trial with 525 EAs (175 per group; estimated 50% women & 50% African American) who report recent heavy drinking and who are not students or graduates of 4-year colleges. Outcomes will be assessed at 1, 3, 6, and 12 months post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 29 years old
- •Not a current student or graduate of a 4-year college with no plans to enroll in a 4-year college in the upcoming semester
- •Stable domicile and contact information
- •Fluent English speaker
- •Adequate literacy (>9th grade reading ability)
- •Two or more heavy episodic drinking episodes in the past month (>5/4 standard drinks for males/ females) or exceeding NIAAA guidelines for high risk drinking (>14/7 drinks per week for men/women).
排除标准
- •Current/past psychosis
- •Current self-initiated AUD/SUD treatment
- •Weekly or greater nonmedical use of prescription drugs or illegal drugs except cannabis
- •Risk for alcohol withdrawal as evidenced by either 1) a recent history of alcohol withdrawal symptoms (tremors, anxiety, hallucinations, and seizures that occur after stopping drinking) or 2) very heavy weekly drinking reports on the alcohol screener (> 40 standard drinks in a typical week in the past month, a value that is > 2 standard deviations above the average drinks per week level observed in our previous brief alcohol intervention studies).
结局指标
主要结局
Change from Baseline Alcohol Consumption and Drug Use at 1-month
时间窗: Enrollment, 1-month post intervention
At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.
Change from Baseline Alcohol Consumption and Drug Use at 6-months
时间窗: Enrollment, 6-months post-intervention
At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.
Change from Baseline Alcohol Consumption and Drug Use at 3-months
时间窗: Enrollment, 3-months post intervention
At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.
Change from Baseline Alcohol Consumption and Drug Use at 12-months
时间窗: Enrollment, 12-months post intervention
At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.
Change from Baseline Alcohol-related Consequences at 6-months
时间窗: Enrollment, 6-months
The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.
Change from Baseline Alcohol-related Consequences at 1-month
时间窗: Enrollment, 1-month
The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.
Change from Baseline Alcohol-related Consequences at 3-months
时间窗: Enrollment, 3-months
The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.
Change from Baseline Alcohol-related Consequences at 12-months
时间窗: Enrollment, 12-months
The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.
次要结局
- Change from Baseline Substance-free and Substance-related Activity Participation at 3-months(Enrollment, 3-months post intervention)
- Change from Baseline Substance-free and Substance-related Activity Participation at 12-months(Enrollment, 12-months post intervention)
- Change from Baseline Alcohol Purchase Task responses at 1-month(Enrollment, 1-month post intervention)
- Change from Baseline Substance-free and Substance-related Activity Participation at 6-months(Enrollment, 6-months post intervention)
- Change from Baseline Substance-free and Substance-related Activity Participation at 1-month(Enrollment, 1-month post intervention)
- Change from Baseline Alcohol Purchase Task responses at 3-months(Enrollment, 3-months post intervention)
- Change from Baseline Alcohol Purchase Task responses at 6-months(Enrollment, 6-months post intervention)
- Change from Baseline Alcohol Purchase Task responses at 12-months(Enrollment, 12-months post intervention)
- Change from Baseline in the Depression, Anxiety, and Stress Scales (DASS) at 1-month(Enrollment, 1-month post intervention)
- Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 3-months(Enrollment, 3-months post intervention)
- Change from Baseline in the Depression, Anxiety, and Stress Scales (DASS) at 3-month(Enrollment, 3-months post intervention)
- Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 1-month(Enrollment, 1-month post intervention)
- Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 6-months(Enrollment, 6-months post intervention)
- Change from Baseline in the Short Self-Regulation Questionnaire (SSRQ) at 12-months(Enrollment, 12-months post intervention)
- Change from Baseline in the Depression, Anxiety, and Stress Scales (DASS) at 6-months(Enrollment, 6-months post intervention)
- Anxiety, and Stress Scales (DASS) at 12-months(Enrollment, 12-months post intervention)
研究者
James G Murphy
Professor
University of Memphis