Trial Outcomes & Findings for Protective Behavioral Strategies and Brief Alcohol Interventions (NCT NCT01168726)
NCT ID: NCT01168726
Last Updated: 2017-07-13
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
365 participants
Primary outcome timeframe
6 Months
Results posted on
2017-07-13
Participant Flow
Participant milestones
| Measure |
Protective Behavioral Strategies
Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
|
Personalized Normative Feedback
Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
|
Alcohol Education
Alcohol Education: Educational information about harms associated with heavy drinking.
|
|---|---|---|---|
|
Overall Study
STARTED
|
111
|
121
|
133
|
|
Overall Study
COMPLETED
|
103
|
112
|
128
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Protective Behavioral Strategies and Brief Alcohol Interventions
Baseline characteristics by cohort
| Measure |
Protective Behavioral Strategies
n=111 Participants
Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
|
Personalized Normative Feedback
n=121 Participants
Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
|
Alcohol Education
n=133 Participants
Alcohol Education: Educational information about harms associated with heavy drinking.
|
Total
n=365 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
111 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
365 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
19.95 Years
STANDARD_DEVIATION 1.36 • n=5 Participants
|
20.12 Years
STANDARD_DEVIATION 1.38 • n=7 Participants
|
20.20 Years
STANDARD_DEVIATION 1.31 • n=5 Participants
|
20.10 Years
STANDARD_DEVIATION 1.35 • n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
238 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=5 Participants
|
121 participants
n=7 Participants
|
133 participants
n=5 Participants
|
365 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsOutcome measures
| Measure |
Protective Behavioral Strategies
n=111 Participants
Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
|
Personalized Normative Feedback
n=121 Participants
Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
|
Alcohol Education
n=133 Participants
Alcohol Education: Educational information about harms associated with heavy drinking.
|
|---|---|---|---|
|
Drinks Per Week
|
12.55 drinks per week
Standard Deviation 8.96
|
9.57 drinks per week
Standard Deviation 8.78
|
13.74 drinks per week
Standard Deviation 10.77
|
PRIMARY outcome
Timeframe: 6 monthsTotal scores on an alcohol problems scale. Possible score range = 0-92. Higher scores are indicative of more alcohol-related problems.
Outcome measures
| Measure |
Protective Behavioral Strategies
n=111 Participants
Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
|
Personalized Normative Feedback
n=121 Participants
Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
|
Alcohol Education
n=133 Participants
Alcohol Education: Educational information about harms associated with heavy drinking.
|
|---|---|---|---|
|
Rutgers Alcohol Problems Index (RAPI)
|
7.68 units on a scale
Standard Deviation 7.25
|
7.76 units on a scale
Standard Deviation 9.42
|
8.91 units on a scale
Standard Deviation 9.17
|
SECONDARY outcome
Timeframe: 6 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.
Outcome measures
| Measure |
Protective Behavioral Strategies
n=111 Participants
Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
|
Personalized Normative Feedback
n=121 Participants
Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
|
Alcohol Education
n=133 Participants
Alcohol Education: Educational information about harms associated with heavy drinking.
|
|---|---|---|---|
|
Drinking Norms Rating Form
|
1.52 units on a scale (standardized)
Standard Deviation 3.52
|
-2.71 units on a scale (standardized)
Standard Deviation 2.57
|
1.20 units on a scale (standardized)
Standard Deviation 3.79
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Protective Behavioral Strategies
n=111 Participants
Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
|
Personalized Normative Feedback
n=121 Participants
Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
|
Alcohol Education
n=133 Participants
Alcohol Education: Educational information about harms associated with heavy drinking.
|
|---|---|---|---|
|
Protective Behavioral Strategies Scale.
|
12.41 units on a scale
Standard Deviation 1.94
|
12.14 units on a scale
Standard Deviation 2.24
|
11.44 units on a scale
Standard Deviation 2.01
|
Adverse Events
Protective Behavioral Strategies
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Personalized Normative Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alcohol Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Matthew P. Martens, Professor; Division Executive Director
University of Missouri
Phone: 573-882-3382
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place