Skip to content

Protective Behavioral Strategies and Brief Alcohol Interventions

Protective Behavioral Strategies and Brief Alcohol Interventions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01168726
Enrollment
365
Registered
2010-07-23
Start date
2010-01-31
Completion date
2010-09-30
Last updated
2017-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Consumption

Brief 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 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.

Interventions

Personalized feedback on use of protective behavioral strategies.

Personalized feedback on how one's own drinking compares to relevant norms.

Educational information about harms associated with heavy drinking.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes

Inclusion criteria

* At least one binge drinking episode in the preceding month

Exclusion criteria

* At-risk for alcohol dependence or major depressive disorder

Design outcomes

Primary

MeasureTime frameDescription
Drinks Per Week6 Months
Rutgers Alcohol Problems Index (RAPI)6 monthsTotal scores on an alcohol problems scale. Possible score range = 0-92. Higher scores are indicative of more alcohol-related problems.

Secondary

MeasureTime frameDescription
Drinking Norms Rating Form6 monthsPerceived 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.
Protective Behavioral Strategies Scale.6 monthsUse 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
Protective Behavioral Strategies
Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
111
Personalized Normative Feedback
Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
121
Alcohol Education
Alcohol Education: Educational information about harms associated with heavy drinking.
133
Total365

Baseline characteristics

CharacteristicPersonalized Normative FeedbackAlcohol EducationProtective Behavioral StrategiesTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
121 Participants133 Participants111 Participants365 Participants
Age, Continuous20.12 Years
STANDARD_DEVIATION 1.38
20.20 Years
STANDARD_DEVIATION 1.31
19.95 Years
STANDARD_DEVIATION 1.36
20.10 Years
STANDARD_DEVIATION 1.35
Region of Enrollment
United States
121 participants133 participants111 participants365 participants
Sex: Female, Male
Female
50 Participants48 Participants29 Participants127 Participants
Sex: Female, Male
Male
71 Participants85 Participants82 Participants238 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 1110 / 1210 / 133
serious
Total, serious adverse events
0 / 1110 / 1210 / 133

Outcome results

Primary

Drinks Per Week

Time frame: 6 Months

ArmMeasureValue (MEAN)Dispersion
Protective Behavioral StrategiesDrinks Per Week12.55 drinks per weekStandard Deviation 8.96
Personalized Normative FeedbackDrinks Per Week9.57 drinks per weekStandard Deviation 8.78
Alcohol EducationDrinks Per Week13.74 drinks per weekStandard Deviation 10.77
Primary

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.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Protective Behavioral StrategiesRutgers Alcohol Problems Index (RAPI)7.68 units on a scaleStandard Deviation 7.25
Personalized Normative FeedbackRutgers Alcohol Problems Index (RAPI)7.76 units on a scaleStandard Deviation 9.42
Alcohol EducationRutgers Alcohol Problems Index (RAPI)8.91 units on a scaleStandard Deviation 9.17
Secondary

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.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Protective Behavioral StrategiesDrinking Norms Rating Form1.52 units on a scale (standardized)Standard Deviation 3.52
Personalized Normative FeedbackDrinking Norms Rating Form-2.71 units on a scale (standardized)Standard Deviation 2.57
Alcohol EducationDrinking Norms Rating Form1.20 units on a scale (standardized)Standard Deviation 3.79
Secondary

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).

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Protective Behavioral StrategiesProtective Behavioral Strategies Scale.12.41 units on a scaleStandard Deviation 1.94
Personalized Normative FeedbackProtective Behavioral Strategies Scale.12.14 units on a scaleStandard Deviation 2.24
Alcohol EducationProtective Behavioral Strategies Scale.11.44 units on a scaleStandard Deviation 2.01

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026