Alcohol ConsumptionNCT01168726
Protective Behavioral Strategies and Brief Alcohol Interventions
A study testing Protective Behavioral Strategies, Personalized Normative Feedback and Alcohol Education in people with Alcohol Consumption, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Excessive college student drinking represents an important public health problem for both the students themselves and those with whom they interact. The objective of this research is to better understand how to reduce such high-risk drinking by improving prevention and treatment programs, which will provide an overall… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- Protective Behavioral Strategies, Personalized Normative Feedback and Alcohol Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least one binge drinking episode in the preceding month
Who cannot join
- At-risk for alcohol dependence or major depressive disorder
Trial locations and contacts
1 site in 1 country.
About this study
Excessive college student drinking represents an important public health problem for both the students themselves and those with whom they interact. The objective of this research is to better understand how to reduce such high-risk drinking by improving prevention and treatment programs, which will provide an overall public health benefit. Subjects in the study will be randomized to one of two brief intervention conditions or an education-only control condition. It is hypothesized that those in the intervention conditions will report greater reductions in alcohol use and alcohol-related problems than those in the control condition.
Read the detailed description
The primary objective of this project is to examine factors that are associated with the effectiveness of intervention programs designed to reduce high-risk drinking among heavy drinking college students. Previous research has found similar effect sizes for different types of multi-component, brief interventions among college students, but little research has assessed the degree to which specific components of such interventions are associated with intervention outcomes. One common component of motivational enhancing interventions among college students involves providing cognitive-behavioral self-control strategies designed to reduce one's use of alcohol, which we term "protective behavioral strategies" (PBS). However, there are two important factors that limit our understanding of the effects of PBS on client outcomes. First, the use of these strategies in motivational enhancing programs has generally not been assessed in a systematic manner, due in part to the fact that until recently a standardized measure of such strategies did not exist. Second, researchers have yet to conduct studies that dismantle the specific effects associated with the PBS component on client outcomes. That is, studies have not tested interventions with and without assessment and feedback regarding a client's use of PBS. Participants in this project will be "at-risk" college student drinkers who will be assigned to one of three conditions: a brief intervention that includes a focus on PBS, a brief intervention that does not include this focus, and an education-only control condition. Participant will complete self-report measures of alcohol-related variables at baseline, 30-day, and 6-month follow-ups. Mixed-model analyses will be used to determine the effectiveness of the intervention programs, and structural equation modeling will be used to determine if increases in PBS result in reductions in alcohol use/alcohol-related problems.
- Conditions
- Alcohol Consumption
- Being tested
- Protective Behavioral Strategies, Personalized Normative Feedback, Alcohol Education
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protective Behavioral StrategiesBehavioural
Personalized feedback on use of protective behavioral strategies.
Personalized Normative FeedbackBehavioural
Personalized feedback on how one's own drinking compares to relevant norms.
Alcohol EducationBehavioural
Educational information about harms associated with heavy drinking.
| Study group | Role | What they receive |
|---|---|---|
| Protective Behavioral Strategies | Experimental | Personalized feedback on use of protective behavioral strategies. Receives: Behavioral: Protective Behavioral Strategies |
| Personalized Normative Feedback | Experimental | Personalized feedback on how one's own drinking compares to relevant norms. Receives: Behavioral: Personalized Normative Feedback |
| Alcohol Education | Active comparator | Educational information about harms associated with heavy drinking. Receives: Behavioral: Alcohol Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinks Per Week
Measured: 6 Months
Rutgers Alcohol Problems Index (RAPI)
Total scores on an alcohol problems scale. Possible score range = 0-92. Higher scores are indicative of more alcohol-related problems.
Measured: 6 months
Secondary outcomes (2)
Drinking Norms Rating Form
Perceived drinking among other students, represented by standardized scores on the Drinking Norms Rating Form. Higher values indicate that the individual perceives higher levels of drinking among other students. Because the scores are standardized their is no hypothetical minimum or maximum, and the scale is standardized with a mean of 0 and standard deviation of 1. So, a mean value of 1.52 means that participants in that condition had an average score that was 1.52 standard deviation above the overall mean of the sample.
Measured: 6 months
Protective Behavioral Strategies Scale.
Use of protective behavioral strategies related to alcohol use. Higher scores indicate more use of the strategies. A total score was calculated by summing the three subscale scores on the measure (range = 3-18).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Matthew P. Martens, University of Missouri-Columbia
- Investigators
- Matthew P Martens, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168726
- Sponsor's protocol ID
- Protective Behaviors
- Other IDs
- 1R21AA016779-01A2
- Status last verified
- Jun 2017
- First submitted
- 20 Jul 2010
- Last updated
- 13 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Behavioral Strategies and Brief Alcohol Interventions
- ClinicalTrials.gov ID
- NCT01168726
- Acronym / sponsor ID
- Protective Behaviors
- Conditions
- Alcohol Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Jul 2010 (estimated)
- Results
- Posted 29 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Excessive college student drinking represents an important public health problem for both the students themselves and those with whom they interact. The objective of this research is to better understand how to reduce such high-risk drinking by improving prevention and treatment programs, which will provide an overall public health benefit. Subjects in the study will be randomized to one of two brief intervention conditions or an education-only control condition. It is hypothesized that those in the intervention conditions will report greater reductions in alcohol use and alcohol-related problems than those in the control condition.
Detailed description
The primary objective of this project is to examine factors that are associated with the effectiveness of intervention programs designed to reduce high-risk drinking among heavy drinking college students. Previous research has found similar effect sizes for different types of multi-component, brief interventions among college students, but little research has assessed the degree to which specific components of such interventions are associated with intervention outcomes. One common component of motivational enhancing interventions among college students involves providing cognitive-behavioral self-control strategies designed to reduce one's use of alcohol, which we term "protective behavioral strategies" (PBS). However, there are two important factors that limit our understanding of the effects of PBS on client outcomes. First, the use of these strategies in motivational enhancing programs has generally not been assessed in a systematic manner, due in part to the fact that until recently a standardized measure of such strategies did not exist. Second, researchers have yet to conduct studies that dismantle the specific effects associated with the PBS component on client outcomes. That is, studies have not tested interventions with and without assessment and feedback regarding a client's use of PBS. Participants in this project will be "at-risk" college student drinkers who will be assigned to one of three conditions: a brief intervention that includes a focus on PBS, a brief intervention that does not include this focus, and an education-only control condition. Participant will complete self-report measures of alcohol-related variables at baseline, 30-day, and 6-month follow-ups. Mixed-model analyses will be used to determine the effectiveness of the intervention programs, and structural equation modeling will be used to determine if increases in PBS result in reductions in alcohol use/alcohol-related problems.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Protective Behavioral Strategies | Experimental | Behavioral: Protective Behavioral StrategiesPersonalized feedback on use of protective behavioral strategies. |
| Personalized Normative Feedback | Experimental | Behavioral: Personalized Normative FeedbackPersonalized feedback on how one's own drinking compares to relevant norms. |
| Alcohol Education | Active comparator | Behavioral: Alcohol EducationEducational information about harms associated with heavy drinking. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- At least one binge drinking episode in the preceding month
Key exclusion criteria (1 listed)
- At-risk for alcohol dependence or major depressive disorder
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 |
|---|---|---|
| Protective Behavioral StrategiesPersonalized feedback on use of protective behavioral strategies. | Behavioural | Protective Behavioral Strategies |
| Personalized Normative FeedbackPersonalized feedback on how one's own drinking compares to relevant norms. | Behavioural | Personalized Normative Feedback |
| Alcohol EducationEducational information about harms associated with heavy drinking. | Behavioural | Alcohol Education |
Primary outcome
Drinks Per Week
Time frame: 6 Months
Rutgers Alcohol Problems Index (RAPI)
Time frame: 6 months
Total scores on an alcohol problems scale. Possible score range = 0-92. Higher scores are indicative of more alcohol-related problems.
2 secondary outcomes
Drinking Norms Rating Form
Time frame: 6 months
Protective Behavioral Strategies Scale.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Matthew P Martens, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protective Behavioral Strategies, Personalized Normative Feedback and Alcohol Education in people with Alcohol Consumption, run by University of Missouri-Columbia 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 1 inclusion and 1 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 13 Jul 2017. 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?
Yes. Results are posted in the registry (first posted 29 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Drinks Per Week (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2017.