Excessive Alcohol ConsumptionNCT01757353
Detroit Area Study of College Student Lifestyles
A study testing BASICS motivational interview, BASICS plus normative enhancement motivational interview and Self-directed: Information only in people with Excessive Alcohol Consumption, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 23 years
- Conditions the study is for
- Excessive Alcohol Consumption
- What is being tested?
- BASICS motivational interview, BASICS plus normative enhancement motivational interview and Self-directed: Information only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 23 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Excessive Alcohol Consumption
- Being tested
- BASICS motivational interview, BASICS plus normative enhancement motivational interview, Self-directed: Information only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASICS motivational interviewBehavioural
BASICS plus normative enhancement motivational interviewBehavioural
Self-directed: Information onlyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self-directed: Information only |
| 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. Receives: Behavioral: BASICS motivational interview |
| 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. Receives: Behavioral: BASICS plus normative enhancement motivational interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 9 months
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.
Measured: up to 9 months
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.
Measured: up to 9 months
Secondary outcomes (2)
Subjective college student role investment questionnaire
This scale assesses involvement, responsibility, importance, and investment in education and the college student role.
Measured: Baseline, 3, 9 months
Trait self-control questionnaire
This scale assesses general dispositional tendencies for planning, thinking before acting, and impulse control
Measured: Baseline, 3, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Excessive Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Bogg, Ph.D., Wayne State University
- Investigators
- Tim Bogg, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757353
- Sponsor's protocol ID
- R00AA017877
- Status last verified
- Feb 2015
- First submitted
- 18 Dec 2012
- Last updated
- 2 Mar 2015
- Results posted
- No
Publications
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.
PubMed 20433626Borsari 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.
PubMed 16187809Borsari B, Carey KB. Effects of a brief motivational intervention with college student drinkers. J Consult Clin Psychol. 2000 Aug;68(4):728-33.
PubMed 10965648Dimeff, 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.
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.
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.
PubMed 12150417Marlatt, G. A. (1998). Harm reduction: Pragmatic strategies for managing high-risk behaviors. New York: Guilford Press.
Miller, W. R., & Rollnick, S. (2002). Motivational interviewing: Preparing people for change (2nd ed.). New York: Guilford Press.
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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detroit Area Study of College Student Lifestyles
- ClinicalTrials.gov ID
- NCT01757353
- Acronym / sponsor ID
- R00AA017877
- Conditions
- Excessive Alcohol Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 28 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-directed: Information only | Active comparator | Behavioral: Self-directed: Information onlyParticipants 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. |
| BASICS motivational interview | Active comparator | Behavioral: BASICS motivational interviewParticipants 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. |
| BASICS plus normative enhancement motivational interview | Experimental | Behavioral: BASICS plus normative enhancement motivational interviewParticipants 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. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BASICS motivational interview | Behavioural | BASICS motivational interview |
| BASICS plus normative enhancement motivational interview | Behavioural | BASICS plus normative enhancement motivational interview |
| Self-directed: Information only | Behavioural | Self-directed: Information only |
Primary outcome
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.
2 secondary outcomes
Subjective college student role investment questionnaire
Time frame: Baseline, 3, 9 months
Trait self-control questionnaire
Time frame: Baseline, 3, 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
- Background: PubMed 20433626Bogg 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.
- Background: PubMed 16187809Borsari 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.
- Background: PubMed 10965648Borsari B, Carey KB. Effects of a brief motivational intervention with college student drinkers. J Consult Clin Psychol. 2000 Aug;68(4):728-33.
- BackgroundDimeff, 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.
- BackgroundGordon, 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.
- Background: PubMed 12150417Krueger 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.
- BackgroundMarlatt, G. A. (1998). Harm reduction: Pragmatic strategies for managing high-risk behaviors. New York: Guilford Press.
- BackgroundMiller, W. R., & Rollnick, S. (2002). Motivational interviewing: Preparing people for change (2nd ed.). New York: Guilford Press.
- BackgroundRoberts, 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Bogg, Ph.D. principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BASICS motivational interview, BASICS plus normative enhancement motivational interview and Self-directed: Information only in people with Excessive Alcohol Consumption, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01757353, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.