Trial Outcomes & Findings for Personalized Feedback Programs for College Students (NCT NCT04975191)
NCT ID: NCT04975191
Last Updated: 2023-05-31
Results Overview
Number of participants who report alcohol use in the past 30 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
252 participants
Primary outcome timeframe
Baseline-3 months
Results posted on
2023-05-31
Participant Flow
Participant milestones
| Measure |
Resources Program (RP)
Resources: Participants will be provided a list of resources available at VCU that are intended to support student success
|
Personalized Feedback Program (PFP)
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
|
Brief Motivational Intervention (BMI)
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
Combined PFP+BMI
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
66
|
61
|
63
|
62
|
|
Overall Study
COMPLETED
|
52
|
56
|
53
|
52
|
|
Overall Study
NOT COMPLETED
|
14
|
5
|
10
|
10
|
Reasons for withdrawal
| Measure |
Resources Program (RP)
Resources: Participants will be provided a list of resources available at VCU that are intended to support student success
|
Personalized Feedback Program (PFP)
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
|
Brief Motivational Intervention (BMI)
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
Combined PFP+BMI
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
13
|
3
|
8
|
8
|
Baseline Characteristics
Personalized Feedback Programs for College Students
Baseline characteristics by cohort
| Measure |
Resources Program (RP)
n=65 Participants
Resources: Participants will be provided a list of resources available at VCU that are intended to support student success
|
Personalized Feedback Program (PFP)
n=59 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
|
Brief Motivational Intervention (BMI)
n=61 Participants
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
Combined PFP+BMI
n=60 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
18.28 years
STANDARD_DEVIATION 1.23 • n=5 Participants
|
18.28 years
STANDARD_DEVIATION 0.57 • n=7 Participants
|
18.26 years
STANDARD_DEVIATION 0.49 • n=5 Participants
|
18.19 years
STANDARD_DEVIATION 0.41 • n=4 Participants
|
18.25 years
STANDARD_DEVIATION 0.76 • n=21 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
57 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
200 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
7 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Sex · Refuse to state
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
59 participants
n=7 Participants
|
61 participants
n=5 Participants
|
60 participants
n=4 Participants
|
245 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline-3 monthsNumber of participants who report alcohol use in the past 30 days
Outcome measures
| Measure |
Resources Program (RP)
n=65 Participants
Resources: Participants will be provided a list of resources available at VCU that are intended to support student success
|
Personalized Feedback Program (PFP)
n=59 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
|
Brief Motivational Intervention (BMI)
n=61 Participants
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
Combined PFP+BMI
n=60 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
|---|---|---|---|---|
|
Change in Alcohol Use
|
19 Participants
|
17 Participants
|
22 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Baseline-3 monthsNumber of participants who report cannabis use in the past 30 days
Outcome measures
| Measure |
Resources Program (RP)
n=65 Participants
Resources: Participants will be provided a list of resources available at VCU that are intended to support student success
|
Personalized Feedback Program (PFP)
n=59 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
|
Brief Motivational Intervention (BMI)
n=61 Participants
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
Combined PFP+BMI
n=60 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
|---|---|---|---|---|
|
Change in Cannabis Use
|
0 Participants
|
5 Participants
|
12 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 3 monthsWell-being was measured with the 14 item Mental Health Continuum-Short Form (MHC-SF; Keyes, 2009; Lamers et al., 2011). Each item asks about past-month frequency of an aspect of positive mental health (e.g., I felt happy) with response options ranging from "never" to "every day." Higher scores reflect more positive well-being. Item scores ranged from 0 to 5 per item. Items were averaged to create a mean well-being measure for which measure scores ranged from a minimum of 0 to a maximum of 5.
Outcome measures
| Measure |
Resources Program (RP)
n=65 Participants
Resources: Participants will be provided a list of resources available at VCU that are intended to support student success
|
Personalized Feedback Program (PFP)
n=59 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
|
Brief Motivational Intervention (BMI)
n=61 Participants
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
Combined PFP+BMI
n=60 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
|---|---|---|---|---|
|
Well-being as Assessed Using 14-item Questionnaire
|
2.91 score on a scale
Standard Deviation 0.95
|
2.98 score on a scale
Standard Deviation 0.99
|
2.98 score on a scale
Standard Deviation 1.12
|
2.9 score on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: 3 monthsAnxiety and depressive symptoms. Abbreviated scales from the Symptom Checklist-90 will be used to assess anxiety and depressive symptoms occurring within the last 30 days (Derogatis, Lipman, \& Covi, 1973). Four items measured anxiety symptoms, and four items assessed depressive symptoms. Responses were rated on a 5-point Likert-type scale ("not at all", "a little bit", "moderately", "quite a bit", and "extremely"). Total scores were calculated for both the anxiety and depression subscales. The scores on each subscale ranged from a minimum of 0 to a maximum of 16. Higher scores reflect higher levels of anxiety and depression.
Outcome measures
| Measure |
Resources Program (RP)
n=65 Participants
Resources: Participants will be provided a list of resources available at VCU that are intended to support student success
|
Personalized Feedback Program (PFP)
n=59 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
|
Brief Motivational Intervention (BMI)
n=61 Participants
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
Combined PFP+BMI
n=60 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
|---|---|---|---|---|
|
Mental Health as Assessed Using 8-item Questionnaire
Anxiety
|
5.12 score on a scale
Standard Deviation 4.12
|
2.98 score on a scale
Standard Deviation 3.42
|
4.00 score on a scale
Standard Deviation 3.59
|
4.32 score on a scale
Standard Deviation 4.35
|
|
Mental Health as Assessed Using 8-item Questionnaire
Depression
|
7.06 score on a scale
Standard Deviation 3.68
|
6.46 score on a scale
Standard Deviation 3.9
|
7.06 score on a scale
Standard Deviation 4.35
|
7.09 score on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 3 monthsParticipants from each of the 4 groups were asked to indicate all of the VCU campus resources (e.g., recreation center, counseling center, writing center) they have utilized in the past 30 days from a list. Our team developed the list, which included 28 resources based on currently available resources for students at VCU. We summed the number of resources each participant used to create a "resource use score". Scores ranged from 0 to 28 and corresponded to the number of resources the participant reported using (e.g., if the participant reported using 3 of the resources on the list, they received a score of 3 on the scale). Higher values represent higher levels of resource use, that is, a better outcome. Mean scores for each group were calculated and are displayed on the outcomes table below.
Outcome measures
| Measure |
Resources Program (RP)
n=65 Participants
Resources: Participants will be provided a list of resources available at VCU that are intended to support student success
|
Personalized Feedback Program (PFP)
n=59 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
|
Brief Motivational Intervention (BMI)
n=61 Participants
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
Combined PFP+BMI
n=60 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
|---|---|---|---|---|
|
Resource Use
|
2 number of resources
Standard Deviation 1.79
|
2.2 number of resources
Standard Deviation 2.23
|
1.52 number of resources
Standard Deviation 1.53
|
2.02 number of resources
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: 3 monthsTen items are included to assess participants' opinions about their condition. Response options include "strongly disagree", "disagree", "neutral", "agree", and "strongly agree". Examples of the statements include "The length of the program was appropriate" and "I learned new information as part of this program." Total scores were averaged to create a mean satisfaction score. Mean scores ranged from a minimum of 0 to a maximum of 5. Higher scores represented higher satisfaction with the program whereas lower scores represented dissatisfaction with the program.
Outcome measures
| Measure |
Resources Program (RP)
n=65 Participants
Resources: Participants will be provided a list of resources available at VCU that are intended to support student success
|
Personalized Feedback Program (PFP)
n=59 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
|
Brief Motivational Intervention (BMI)
n=61 Participants
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
Combined PFP+BMI
n=60 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
|---|---|---|---|---|
|
Program Satisfaction
|
4.4 score on a scale
Standard Deviation 3.68
|
3.83 score on a scale
Standard Deviation 2.57
|
3.3 score on a scale
Standard Deviation 3.38
|
4.3 score on a scale
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: 3 monthsRisk comprehension will be assessed using 10 questions related to participants' beliefs about what factors contribute to substance use and mental health. Correct responses for each question were scored as 1, and incorrect responses were scored as 0. Responses are summed to yield a single score. Scores ranged from a minimum of 0 to a maximum of 10. Higher scores indicate higher knowledge of risk for substance use problems.
Outcome measures
| Measure |
Resources Program (RP)
n=65 Participants
Resources: Participants will be provided a list of resources available at VCU that are intended to support student success
|
Personalized Feedback Program (PFP)
n=59 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
|
Brief Motivational Intervention (BMI)
n=61 Participants
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
Combined PFP+BMI
n=60 Participants
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
Substance Use Feedback Program (BMI): Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
|
|---|---|---|---|---|
|
Risk Comprehension as Assessed Using 10-item Questionnaire
|
8.33 score on a scale
Standard Deviation 1.5
|
8.41 score on a scale
Standard Deviation 1.78
|
8.53 score on a scale
Standard Deviation 1.25
|
8.65 score on a scale
Standard Deviation 1.42
|
Adverse Events
Resources Program (RP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Personalized Feedback Program (PFP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Brief Motivational Intervention (BMI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combined PFP+BMI
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