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Detroit Area Study of College Student Lifestyles

Primary Purpose

Excessive Alcohol Consumption

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BASICS motivational interview
BASICS plus normative enhancement motivational interview
Self-directed: Information only
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Excessive Alcohol Consumption

Eligibility Criteria

18 Years - 23 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wayne State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Self-directed: Information only

BASICS motivational interview

BASICS plus normative enhancement motivational interview

Arm Description

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.

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.

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.

Outcomes

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.
This measure is assessed using a structured interview.
Young adult alcohol consequences questionnaire
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
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
This scale assesses involvement, responsibility, importance, and investment in education and the college student role.
Trait self-control questionnaire
This scale assesses general dispositional tendencies for planning, thinking before acting, and impulse control

Full Information

First Posted
December 18, 2012
Last Updated
February 26, 2015
Sponsor
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT01757353
Brief Title
Detroit Area Study of College Student Lifestyles
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Excessive Alcohol Consumption

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-directed: Information only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
BASICS motivational interview
Arm Type
Active Comparator
Arm Description
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.
Arm Title
BASICS plus normative enhancement motivational interview
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BASICS motivational interview
Intervention Type
Behavioral
Intervention Name(s)
BASICS plus normative enhancement motivational interview
Intervention Type
Behavioral
Intervention Name(s)
Self-directed: Information only
Primary Outcome Measure Information:
Title
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.
Description
This measure is assessed using a structured interview.
Time Frame
up to 9 months
Title
Young adult alcohol consequences questionnaire
Description
This instrument assesses the co-occurrence of behavioral problems and alcohol consumption, including physical, social, performance, and risk-related behaviors and outcomes.
Time Frame
up to 9 months
Title
Hypothetical role-based decisions-to-drink questionnaire
Description
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.
Time Frame
up to 9 months
Secondary Outcome Measure Information:
Title
Subjective college student role investment questionnaire
Description
This scale assesses involvement, responsibility, importance, and investment in education and the college student role.
Time Frame
Baseline, 3, 9 months
Title
Trait self-control questionnaire
Description
This scale assesses general dispositional tendencies for planning, thinking before acting, and impulse control
Time Frame
Baseline, 3, 9 months
Other Pre-specified Outcome Measures:
Title
Readiness to change drinking patterns questionnaire
Description
This questionnaire assesses an individual's stage of motivation to enact alcohol-related behavioral change.
Time Frame
Baseline, 3, 9 months
Title
Comprehensve effects of alcohol questionnaire
Description
This questionnaire assesses positive and negative drinking expectancies.
Time Frame
Baseline, 3, 9 months
Title
Alcohol perceived risks questionnaire
Description
This questionnaire assesses a college student's perception of various risks and outcomes associated with alcohol consumption.
Time Frame
Baseline, 3, 9 months
Title
Drinking norms rating form
Description
This questionnaire assesses a college student's perceptions of what is typical for the alcohol consumption patterns of most college students.
Time Frame
Baseline, 3, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Bogg, Ph.D.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20433626
Citation
Bogg T, Finn PR. A self-regulatory model of behavioral disinhibition in late adolescence: integrating personality traits, externalizing psychopathology, and cognitive capacity. J Pers. 2010 Apr;78(2):441-70. doi: 10.1111/j.1467-6494.2010.00622.x.
Results Reference
background
PubMed Identifier
16187809
Citation
Borsari B, Carey KB. Two brief alcohol interventions for mandated college students. Psychol Addict Behav. 2005 Sep;19(3):296-302. doi: 10.1037/0893-164X.19.3.296.
Results Reference
background
PubMed Identifier
10965648
Citation
Borsari B, Carey KB. Effects of a brief motivational intervention with college student drinkers. J Consult Clin Psychol. 2000 Aug;68(4):728-33.
Results Reference
background
Citation
Dimeff, L. A., Baer, J. S., Kivlahan, D. R., & Marlatt, G. A. (1999). Brief alcohol screening and intervention for college students: A harm reduction approach. New York: Guilford Press.
Results Reference
background
Citation
Gordon, R. (1987). An operational classification of disease prevention. In J. A. Steinberg & M. M. Silverman (Eds.), Preventing mental disorders: A research perspective (DHHS Publication No. [ADM] 87-1492, pp. 20-26). Rockville, MD: National Institute of Mental Health.
Results Reference
background
PubMed Identifier
12150417
Citation
Krueger RF, Hicks BM, Patrick CJ, Carlson SR, Iacono WG, McGue M. Etiologic connections among substance dependence, antisocial behavior, and personality: modeling the externalizing spectrum. J Abnorm Psychol. 2002 Aug;111(3):411-24.
Results Reference
background
Citation
Marlatt, G. A. (1998). Harm reduction: Pragmatic strategies for managing high-risk behaviors. New York: Guilford Press.
Results Reference
background
Citation
Miller, W. R., & Rollnick, S. (2002). Motivational interviewing: Preparing people for change (2nd ed.). New York: Guilford Press.
Results Reference
background
Citation
Roberts, B. W. & Caspi, A. (2003). The cumulative continuity model of personality development: Striking a balance between continuity and change in personality traits across the life course. In R.M. Staudinger & U. Lindenberger (Eds.), Understanding human development: Lifespan psychology in exchange with other disciplines (pp. 183-214). Dordrecht, NL: Kluwer Academic Publishers.
Results Reference
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Detroit Area Study of College Student Lifestyles

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