Trial Outcomes & Findings for The College, Alcohol and Peers Study (CAPS) (NCT NCT03890484)
NCT ID: NCT03890484
Last Updated: 2024-04-17
Results Overview
Number of drinks consumed
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
During 1 hour ad-lib period, starting an average of 1 hour after Baseline.
Results posted on
2024-04-17
Participant Flow
Participants were recruited through University registrar's list emails, flyers posted around campus, and social media advertisements. Participants were recruited and enrolled between December 2019 and July 2022. Recruitment was paused from March 2020 to August 2021 due to the COVID-19 pandemic and again from August 2022 until early termination in June 2023 due to key personnel and funding changes. Study effective termination was July 2022.
Participants were completed informed consent and enrolled at the time of the alcohol administration session.
Participant milestones
| Measure |
New Peers
Participants will drink with two new peers (i.e. strangers), who they did not know prior to the study and their Peer Type.
Peer Type - New Peer: Participants drink with 2 unfamiliar confederate peers
|
Close Friends
Participants will recruit and drink with two of their close friends and their Peer Type
Peer Type - Close Friends: Participants drink with 2 close friends
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
8
|
|
Overall Study
Completed Alcohol Admin Session
|
5
|
8
|
|
Overall Study
COMPLETED
|
4
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
New Peers
Participants will drink with two new peers (i.e. strangers), who they did not know prior to the study and their Peer Type.
Peer Type - New Peer: Participants drink with 2 unfamiliar confederate peers
|
Close Friends
Participants will recruit and drink with two of their close friends and their Peer Type
Peer Type - Close Friends: Participants drink with 2 close friends
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
The College, Alcohol and Peers Study (CAPS)
Baseline characteristics by cohort
| Measure |
New Peers
n=5 Participants
Participants will drink with two new peers (i.e. strangers), who they did not know prior to the study and their Peer Type.
Peer Type - New Peer: Participants drink with 2 unfamiliar confederate peers
|
Close Friends
n=8 Participants
Participants will recruit and drink with two of their close friends and their Peer Type
Peer Type - Close Friends: Participants drink with 2 close friends
|
Total
n=13 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
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
21.4 years
STANDARD_DEVIATION 0.89 • n=5 Participants
|
21.5 years
STANDARD_DEVIATION 0.76 • n=7 Participants
|
21.46 years
STANDARD_DEVIATION 0.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Broad Social Motives for Friends
|
4.06 units on a scale
STANDARD_DEVIATION 0.44 • n=5 Participants
|
4.58 units on a scale
STANDARD_DEVIATION 0.32 • n=7 Participants
|
4.38 units on a scale
STANDARD_DEVIATION 0.44 • n=5 Participants
|
|
Broad Social Motives for New Peers
|
2.87 units on a scale
STANDARD_DEVIATION 0.23 • n=5 Participants
|
3.94 units on a scale
STANDARD_DEVIATION 0.51 • n=7 Participants
|
3.53 units on a scale
STANDARD_DEVIATION 0.68 • n=5 Participants
|
|
Negative Affect
|
1.4 units on a scale
STANDARD_DEVIATION 0.27 • n=5 Participants
|
1.11 units on a scale
STANDARD_DEVIATION 0.14 • n=7 Participants
|
1.22 units on a scale
STANDARD_DEVIATION 0.24 • n=5 Participants
|
|
Positive Affect
|
2.7 units on a scale
STANDARD_DEVIATION 0.68 • n=5 Participants
|
3.16 units on a scale
STANDARD_DEVIATION 0.50 • n=7 Participants
|
2.98 units on a scale
STANDARD_DEVIATION 0.60 • n=5 Participants
|
|
Prior 30 day Alcohol Consequences
|
16.2 units on a scale
STANDARD_DEVIATION 6.72 • n=5 Participants
|
20 units on a scale
STANDARD_DEVIATION 15.76 • n=7 Participants
|
18.54 units on a scale
STANDARD_DEVIATION 12.79 • n=5 Participants
|
|
Prior 30 day Alcohol Use
|
2.91 Number of standard drinks
STANDARD_DEVIATION 0.93 • n=5 Participants
|
3.04 Number of standard drinks
STANDARD_DEVIATION 1.15 • n=7 Participants
|
2.99 Number of standard drinks
STANDARD_DEVIATION 1.03 • n=5 Participants
|
PRIMARY outcome
Timeframe: During 1 hour ad-lib period, starting an average of 1 hour after Baseline.Number of drinks consumed
Outcome measures
| Measure |
New Peers
n=5 Participants
Participants will drink with two new peers (i.e. strangers), who they did not know prior to the study and their Peer Type.
Peer Type - New Peer: Participants drink with 2 unfamiliar confederate peers
|
Close Friends
n=8 Participants
Participants will recruit and drink with two of their close friends and their Peer Type
Peer Type - Close Friends: Participants drink with 2 close friends
|
|---|---|---|
|
Alcohol Use
|
3.2 Number of drinks
Standard Deviation 0.45
|
3.63 Number of drinks
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: 4 weeks following ad-lib.Number of drinks consumed, self-reported the morning after drinking events
Outcome measures
| Measure |
New Peers
n=4 Participants
Participants will drink with two new peers (i.e. strangers), who they did not know prior to the study and their Peer Type.
Peer Type - New Peer: Participants drink with 2 unfamiliar confederate peers
|
Close Friends
n=7 Participants
Participants will recruit and drink with two of their close friends and their Peer Type
Peer Type - Close Friends: Participants drink with 2 close friends
|
|---|---|---|
|
Alcohol Use - Daily Diary
|
3.8 Number of drinks
Standard Deviation 2.57
|
2.61 Number of drinks
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: 4 weeks following ad-lib.Self-report of the Young Adult Alcohol Problems Screening Test (YAAPST). Count of number of consequences experienced. Range: 0-27. Higher scores represent more consequences experienced.
Outcome measures
| Measure |
New Peers
n=4 Participants
Participants will drink with two new peers (i.e. strangers), who they did not know prior to the study and their Peer Type.
Peer Type - New Peer: Participants drink with 2 unfamiliar confederate peers
|
Close Friends
n=7 Participants
Participants will recruit and drink with two of their close friends and their Peer Type
Peer Type - Close Friends: Participants drink with 2 close friends
|
|---|---|---|
|
Alcohol Consequences
|
0.40 Number of consequences
Standard Deviation 0.74
|
0.30 Number of consequences
Standard Deviation 0.56
|
PRIMARY outcome
Timeframe: Change from baseline (alone) to 20 minutes following Peer Type intervention.Scores on the Balloon Analogue Risk Task (BART). Scores are calculated by adding the number of pumps for unexploded balloons, with higher scores reflecting greater risk-taking. Range varies - explosions are at a random point between 1 and 128 pumps.
Outcome measures
| Measure |
New Peers
n=5 Participants
Participants will drink with two new peers (i.e. strangers), who they did not know prior to the study and their Peer Type.
Peer Type - New Peer: Participants drink with 2 unfamiliar confederate peers
|
Close Friends
n=8 Participants
Participants will recruit and drink with two of their close friends and their Peer Type
Peer Type - Close Friends: Participants drink with 2 close friends
|
|---|---|---|
|
Risk-taking
|
8.02 Number of pumps
Standard Deviation 9.57
|
15.29 Number of pumps
Standard Deviation 19.83
|
PRIMARY outcome
Timeframe: Change from baseline (alone) to immediately following ad-lib, an average of 2 hours after baseline.Scores on the Balloon Analogue Risk Task (BART). Scores are calculated by adding the number of pumps for unexploded balloons, with higher scores reflecting greater risk-taking. Range varies - explosions are at a random point between 1 and 128 pumps.
Outcome measures
| Measure |
New Peers
n=5 Participants
Participants will drink with two new peers (i.e. strangers), who they did not know prior to the study and their Peer Type.
Peer Type - New Peer: Participants drink with 2 unfamiliar confederate peers
|
Close Friends
n=8 Participants
Participants will recruit and drink with two of their close friends and their Peer Type
Peer Type - Close Friends: Participants drink with 2 close friends
|
|---|---|---|
|
Risk-taking
|
12.83 Number of pumps
Standard Deviation 10.77
|
28.27 Number of pumps
Standard Deviation 21.11
|
Adverse Events
New Peers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Close Friends
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place