Protective Behavioral Strategies and Brief Alcohol Interventions

• Sponsor: University of Missouri-Columbia (Other)
• Overall Status: Completed
• CT.gov ID: NCT01168726
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 365
• Location: 1
• Arms: 3
• Duration (Months): 8
• Patients Per Site Per Month: 45.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Consumption	Behavioral: Protective Behavioral Strategies; Behavioral: Personalized Normative Feedback; Behavioral: Alcohol Education	N/A

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

• Study Type: Interventional
• Actual Enrollment: 365 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Protective Behavioral Strategies and Brief Alcohol Interventions
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Protective Behavioral Strategies Personalized feedback on use of protective behavioral strategies.	Behavioral: Protective Behavioral Strategies; Personalized feedback on use of protective behavioral strategies.
Experimental: Personalized Normative Feedback Personalized feedback on how one's own drinking compares to relevant norms.	Behavioral: Personalized Normative Feedback; Personalized feedback on how one's own drinking compares to relevant norms.
Active Comparator: Alcohol Education Educational information about harms associated with heavy drinking.	Behavioral: Alcohol Education; Educational information about harms associated with heavy drinking.

Outcome Measures

Primary Outcome Measures

1. Drinks Per Week [6 Months]

2. Rutgers Alcohol Problems Index (RAPI) [6 months]

   Total scores on an alcohol problems scale. Possible score range = 0-92. Higher scores are indicative of more alcohol-related problems.

Secondary Outcome Measures

1. Drinking Norms Rating Form [6 months]

   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.

2. Protective Behavioral Strategies Scale. [6 months]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 24 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Missouri	Columbia	Missouri	United States	65211

Sponsors and Collaborators

• University of Missouri-Columbia
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Matthew P Martens, PhD, University of Missouri-Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matthew P. Martens, Associate Professor, University of Missouri-Columbia
• ClinicalTrials.gov Identifier: NCT01168726
• Other Study ID Numbers: Protective Behaviors; 1R21AA016779-01A2
• First Posted: Jul 23, 2010
• Last Update Posted: Jul 13, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Alcohol Drinking

Study Results

Participant Flow

Arm/Group Title	Protective Behavioral Strategies	Personalized Normative Feedback	Alcohol Education
Arm/Group Description	Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.	Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.	Alcohol Education: Educational information about harms associated with heavy drinking.
Period Title: Overall Study
STARTED	111	121	133
COMPLETED	103	112	128
NOT COMPLETED	8	9	5

Baseline Characteristics

Arm/Group Title	Protective Behavioral Strategies	Personalized Normative Feedback	Alcohol Education	Total
Arm/Group Description	Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.	Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.	Alcohol Education: Educational information about harms associated with heavy drinking.	Total of all reporting groups
Overall Participants	111	121	133	365
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	111 100%	121 100%	133 100%	365 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	19.95 (1.36)	20.12 (1.38)	20.20 (1.31)	20.10 (1.35)
Sex: Female, Male (Count of Participants)
Female	29 26.1%	50 41.3%	48 36.1%	127 34.8%
Male	82 73.9%	71 58.7%	85 63.9%	238 65.2%
Region of Enrollment (participants) [Number]
United States	111 100%	121 100%	133 100%	365 100%

Outcome Measures

1. Primary Outcome

Title	Drinks Per Week
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Protective Behavioral Strategies	Personalized Normative Feedback	Alcohol Education
Arm/Group Description	Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.	Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.	Alcohol Education: Educational information about harms associated with heavy drinking.
Measure Participants	111	121	133
Mean (Standard Deviation) [drinks per week]	12.55 (8.96)	9.57 (8.78)	13.74 (10.77)

2. Primary Outcome

Title	Rutgers Alcohol Problems Index (RAPI)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Protective Behavioral Strategies	Personalized Normative Feedback	Alcohol Education
Arm/Group Description	Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.	Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.	Alcohol Education: Educational information about harms associated with heavy drinking.
Measure Participants	111	121	133
Mean (Standard Deviation) [units on a scale]	7.68 (7.25)	7.76 (9.42)	8.91 (9.17)

3. Secondary Outcome

Title	Drinking Norms Rating Form
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Protective Behavioral Strategies	Personalized Normative Feedback	Alcohol Education
Arm/Group Description	Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.	Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.	Alcohol Education: Educational information about harms associated with heavy drinking.
Measure Participants	111	121	133
Mean (Standard Deviation) [units on a scale (standardized)]	1.52 (3.52)	-2.71 (2.57)	1.20 (3.79)

4. Secondary Outcome

Title	Protective Behavioral Strategies Scale.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Protective Behavioral Strategies	Personalized Normative Feedback	Alcohol Education
Arm/Group Description	Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.	Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.	Alcohol Education: Educational information about harms associated with heavy drinking.
Measure Participants	111	121	133
Mean (Standard Deviation) [units on a scale]	12.41 (1.94)	12.14 (2.24)	11.44 (2.01)

Adverse Events

Arm/Group Title	Protective Behavioral Strategies		Personalized Normative Feedback		Alcohol Education
Arm/Group Description	Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.		Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.		Alcohol Education: Educational information about harms associated with heavy drinking.
All Cause Mortality
	Protective Behavioral Strategies		Personalized Normative Feedback		Alcohol Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Protective Behavioral Strategies		Personalized Normative Feedback		Alcohol Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/111 (0%)		0/121 (0%)		0/133 (0%)
Other (Not Including Serious) Adverse Events
	Protective Behavioral Strategies		Personalized Normative Feedback		Alcohol Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/111 (0%)		0/121 (0%)		0/133 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.