Detroit Area Study of College Student Lifestyles

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Wayne State University
Sponsor:
Information provided by (Responsible Party):
Tim Bogg, Ph.D., Wayne State University
ClinicalTrials.gov Identifier:
NCT01757353
First received: December 18, 2012
Last updated: December 27, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Excessive Alcohol Consumption
Behavioral: BASICS motivational interview
Behavioral: BASICS plus normative enhancement motivational interview
Behavioral: Self-directed: Information only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • 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. [ Time Frame: up to 9 months ]
    This measure is assessed using a structured interview.

  • Young adult alcohol consequences questionnaire [ Time Frame: 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.

  • Hypothetical role-based decisions-to-drink questionnaire [ Time Frame: 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.


Secondary Outcome Measures:
  • Subjective college student role investment questionnaire [ Time Frame: Baseline, 3, 9 months ]
    This scale assesses involvement, responsibility, importance, and investment in education and the college student role.

  • Trait self-control questionnaire [ Time Frame: Baseline, 3, 9 months ]
    This scale assesses general dispositional tendencies for planning, thinking before acting, and impulse control


Other Outcome Measures:
  • Readiness to change drinking patterns questionnaire [ Time Frame: Baseline, 3, 9 months ]
    This questionnaire assesses an individual's stage of motivation to enact alcohol-related behavioral change.

  • Comprehensve effects of alcohol questionnaire [ Time Frame: Baseline, 3, 9 months ]
    This questionnaire assesses positive and negative drinking expectancies.

  • Alcohol perceived risks questionnaire [ Time Frame: Baseline, 3, 9 months ]
    This questionnaire assesses a college student's perception of various risks and outcomes associated with alcohol consumption.

  • Drinking norms rating form [ Time Frame: Baseline, 3, 9 months ]
    This questionnaire assesses a college student's perceptions of what is typical for the alcohol consumption patterns of most college students.


Estimated Enrollment: 150
Study Start Date: December 2012
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Self-directed: Information only
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.
Behavioral: Self-directed: Information only
Active Comparator: BASICS motivational interview
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.
Behavioral: BASICS motivational interview
Experimental: BASICS plus normative enhancement motivational interview
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.
Behavioral: BASICS plus normative enhancement motivational interview

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 23 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • We initially screen anonymously on the telephone for the inclusion/exclusion criteria (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757353

Contacts
Contact: Tim Bogg, Ph.D. 313-577-2836 tbogg@wayne.edu

Locations
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Contact: Tim Bogg, Ph.D.    313-577-2836    tbogg@wayne.edu   
Principal Investigator: Tim Bogg, Ph.D.         
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Tim Bogg, Ph.D. Wayne State University
  More Information

Publications:
Responsible Party: Tim Bogg, Ph.D., Assistant Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT01757353     History of Changes
Other Study ID Numbers: R00 AA017877
Study First Received: December 18, 2012
Last Updated: December 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior

ClinicalTrials.gov processed this record on September 16, 2014