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临床试验/NCT01757353
NCT01757353已完成不适用

Detroit Area Study of College Student Lifestyles

Wayne State University1 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2012年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
181
试验地点
1
主要终点
Past 30-day typical weekly alcohol consumption, as well as peak alcohol drinking episodes. From this information, past 30-day typical and peak blood alcohol content can be calculated.

研究概览

简要总结

The goal of this research study is to compare three harm reduction approaches for at-risk college student drinkers. One approach provides generic risk-related information after an initial interview/questionnaire assessment session. A second approach uses an established motivational interviewing framework (Brief Alcohol Screening and Intervention for College Students; BASICS) that provides personalized feedback in a follow-up session. A third approach also uses BASICS, but tests the utility of a personality-informed module for this approach that is informed by the social investment hypothesis.

详细描述

While individual difference factors, such as trait self-control and subjective college student role investment, appear to be important predictors of excessive alcohol consumption and related problems, these factors are not typically incorporated into indicated prevention strategies. Indicated prevention usually focuses on groups or individuals who already express some aspects of a health-related problem (e.g., heavy episodic drinking), or who, at the very least, exhibit markers of risk (e.g., early age of first drink) associated with the development of a health-related problem (Gordon, 1987). The primary aim of the current proposal is to incorporate a personality-informed module into an existing motivational interviewing framework for alcohol-related harm reduction and test its efficacy compared to an information-only approach (i.e., informational packet) and a conventional strategy for indicated prevention (i.e., Brief Alcohol Screening and Intervention for College Students, BASICS; Dimeff et al., 1999) that has provided evidence for reduced risk of alcohol-related problems in randomized controlled trials (Borsari & Carey, 2000; 2005).

Motivational interviewing is a common technique used to address ambivalence and/or resistance to behavioral change. Motivational interviewing is commonly used in the context of health-related behaviors, such as excessive alcohol consumption, where an individual might not have experienced any serious consequences (e.g., driving while intoxicated), but may still be at risk for problems (Miller & Rollnick, 2002). In motivational interviewing, a tone of collaboration and attentiveness is considered critical to the success of the interaction. The primary goal is to guide an individual toward increased motivation to change (and actual behavioral change) by being responsive to the desires and concerns of the individual as it relates to change, and by having an individual commit to even the most modest of change goals (e.g., consuming beverages with reduced alcohol by volume in situations that are known to be high-risk, rather than a favorite, higher alcohol-by-volume beverage). Motivational interviewing is well-suited to accommodate a personality-informed module for change due to its emphasis on an individual's unique profile of factors.

In BASICS, a harm reduction approach is used to inform the assessment and content of the initial assessment session, as well as the follow-up feedback session (Dimeff et al., 1999). Consistent with research showing there to be a continuum of problems for alcohol and other externalizing behaviors (Bogg & Finn, 2010; Krueger et al., 2002), the harm reduction approach emphasizes that any movement toward reduced risk and harm, regardless of its impact, is positive movement, even if a person might be farther along the continuum of harm (Marlatt, 1998). The current proposal seeks to test an augmentation of the harm reduction approach of BASICS with a normative enhancement approach derived from the social investment hypothesis of the Cumulative Continuity Model of personality development (Roberts & Caspi, 2003).

According to the social investment hypothesis, the process of commitment to normative roles, such as college student, is ''thought to exact a form of social control through the role demands embedded in these contexts that call on individuals to act with more responsibility and probity'' (Roberts & Caspi, 2003; p. 203). To the extent that further commitment, investment, and involvement in the college student role can be fostered, then a concomitant increase in trait self-control should be expected as well, independent of harm reduction effects. As suggested by the findings described above, the effect of increased subjective college student role investment could be to deflect a risky trajectory for alcohol-related problems - an effect that could be further amplified by corresponding increases in trait self-control. This normative enhancement (NE) approach is posited to be particularly useful for those individuals who do not recognize or are steadfastly resistant to even minor harm reduction efforts conveyed through the motivational interviewing framework of BASICS. The strategy of the normative enhancement approach is to capitalize on an individual's goals for involvement in roles - especially those roles, such as college student, which are nominally voluntary in nature.

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
18 Years 至 23 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •We initially screen anonymously on the telephone for the inclusion/

排除标准

  • •(see attached phone screen). The responses obtained from respondents are used only to determine if they meet study criteria. Their names and responses are not recorded and the information they provide is shredded when the screen is completed.
  • •be currently enrolled in full-time university coursework
  • •be between the ages of 18 and 23 years
  • •understand and be able to respond to screening questions in English
  • •be able to read at a Grade 6 level
  • •have consumed at least 4 (for women) or 5 (for men) standard drinks at least two times in the past 30 days OR typically consume at least 3 (for women) or 4 (for men) standard drinks on a drinking occasion
  • •meet at least one of the DSM-IV diagnostic criteria for alcohol dependence OR score 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT
  • •Exclusion Criteria:
  • •not have major cognitive impairments (i.e., assessed by whether they can understand and respond adequately to all screening questions)
  • •not have any history of traumatic brain injury. Subjects also are excluded if they report a history of any serious head injury.
  • •not have a history of psychotic symptoms or Bipolar Disorder
  • •not be taking medications for cancer, AIDS treatment, or epilepsy
  • •not be taking other medications that will affect behavior, such as major tranquilizers or antipsychotics
  • •not currently receiving voluntary or mandated counseling or treatment for substance use

研究组 & 干预措施

Self-directed: Information only

Active Comparator

Participants in this arm will complete a baseline assessment, followed by a 50-minute brief motivational interview (the Brief Alcohol Screening and Intervention for College Students; BASICS) 10-14 days after the initial assessment. Participants in this arm will complete follow-up assessments at approximately 3 and 9 months.

干预措施: Self-directed: Information only (Behavioral)

BASICS motivational interview

Active Comparator

Participants in this arm will complete a baseline assessment, immediately after which they will be administered alcohol-related informational sheets. These participants will participate in follow-up assessment sessions at approximately 3 and 9 months.

干预措施: BASICS motivational interview (Behavioral)

BASICS plus normative enhancement motivational interview

Experimental

Participants in this arm will complete a baseline assessment, followed by a 60-minute brief motivational interview (the Brief Alcohol Screening and Intervention for College Students, with a normative enhancement module) 10-14 days after the initial assessment. Participants in this arm will complete follow-up assessments at approximately 3 and 9 months.

干预措施: BASICS plus normative enhancement motivational interview (Behavioral)

结局指标

主要结局

Past 30-day typical weekly alcohol consumption, as well as peak alcohol drinking episodes. From this information, past 30-day typical and peak blood alcohol content can be calculated.

时间窗: up to 9 months

This measure is assessed using a structured interview.

Hypothetical role-based decisions-to-drink questionnaire

时间窗: up to 9 months

Four hypothetical college student drinking scenarios that vary in rewarding and punishing role-related information assess decisions to attend, to drink, and how much alcohol would be consumed.

Young adult alcohol consequences questionnaire

时间窗: up to 9 months

This instrument assesses the co-occurrence of behavioral problems and alcohol consumption, including physical, social, performance, and risk-related behaviors and outcomes.

次要结局

  • Trait self-control questionnaire(Baseline, 3, 9 months)
  • Subjective college student role investment questionnaire(Baseline, 3, 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tim Bogg, Ph.D.

Assistant Professor

Wayne State University

研究点 (1)

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