Alcohol Use, Unspecified
Conditions
Brief summary
The purpose of this research study is to evaluate the effectiveness of different forms of personalized feedback intended to help students make their best personal choices to support their health and well-being in college.
Detailed description
Risky substance use among college students is a widespread challenge that requires innovative prevention methods to address. A primary aim of this study is to assess the efficacy of receiving different types of personalized feedback on the substance use and wellbeing of college students. This preliminary efficacy will be evaluated through a multi-part randomized controlled trial comparing four conditions: (1) resources program, (2) on-line Personalized Feedback Program (PFP), (3) on-line Substance Use Feedback Program (based on brief motivational intervention (BMI) principles), and (4) PFP+BMI. At the first time point, participants will be randomly selected into one of four conditions. Participants have an equal chance of being assigned to any one of the conditions. All participants will complete follow-up surveys at two additional timepoints (30 day follow-up; 3-month follow-up) to determine any changes that have occurred since they took part in their program at Time Point 1. After the final survey, all participants, regardless of their initial group, will be invited to receive all of the personalized feedback components available across all conditions. Findings from this study have great potential to enhance the effectiveness of college student substance use prevention programming and improve college student wellbeing.
Interventions
Participants will be provided a list of resources available at VCU that are intended to support student success
Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
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
Sponsors
Study design
Eligibility
Inclusion criteria
* Consent: Voluntary consent must be provided. * Age: Students over the age of 18 may participate. * Year in college: Newly enrolled freshmen. * Enrollment status: Only full-time VCU students will participate.
Exclusion criteria
* Age: Under the age of 18 * Year in College: A sophomore, junior or senior * Enrollment Status: Enrolled part-time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alcohol Use | Baseline-3 months | Number of participants who report alcohol use in the past 30 days |
| Change in Cannabis Use | Baseline-3 months | Number of participants who report cannabis use in the past 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resource Use | 3 months | Participants 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. |
| Well-being as Assessed Using 14-item Questionnaire | 3 months | Well-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. |
| Risk Comprehension as Assessed Using 10-item Questionnaire | 3 months | Risk 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. |
| Program Satisfaction | 3 months | Ten 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. |
| Mental Health as Assessed Using 8-item Questionnaire | 3 months | Anxiety 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Resources Program (RP) Resources: Participants will be provided a list of resources available at VCU that are intended to support student success | 65 |
| 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 | 59 |
| 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 | 61 |
| 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 | 60 |
| Total | 245 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 3 | 8 | 8 |
| Overall Study | Protocol Violation | 1 | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | Resources Program (RP) | Total | Combined PFP+BMI | Brief Motivational Intervention (BMI) | Personalized Feedback Program (PFP) |
|---|---|---|---|---|---|
| Age, Continuous | 18.28 years STANDARD_DEVIATION 1.23 | 18.25 years STANDARD_DEVIATION 0.76 | 18.19 years STANDARD_DEVIATION 0.41 | 18.26 years STANDARD_DEVIATION 0.49 | 18.28 years STANDARD_DEVIATION 0.57 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 47 Participants | 6 Participants | 11 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 41 Participants | 10 Participants | 10 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 26 Participants | 9 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 13 Participants | 6 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) White | 33 Participants | 113 Participants | 29 Participants | 28 Participants | 23 Participants |
| Region of Enrollment United States | 65 participants | 245 participants | 60 participants | 61 participants | 59 participants |
| Sex/Gender, Customized Sex Female | 57 Participants | 200 Participants | 48 Participants | 54 Participants | 41 Participants |
| Sex/Gender, Customized Sex Male | 7 Participants | 43 Participants | 12 Participants | 7 Participants | 17 Participants |
| Sex/Gender, Customized Sex Refuse to state | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Change in Alcohol Use
Number of participants who report alcohol use in the past 30 days
Time frame: Baseline-3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Resources Program (RP) | Change in Alcohol Use | 19 Participants |
| Personalized Feedback Program (PFP) | Change in Alcohol Use | 17 Participants |
| Brief Motivational Intervention (BMI) | Change in Alcohol Use | 22 Participants |
| Combined PFP+BMI | Change in Alcohol Use | 18 Participants |
Change in Cannabis Use
Number of participants who report cannabis use in the past 30 days
Time frame: Baseline-3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Resources Program (RP) | Change in Cannabis Use | 0 Participants |
| Personalized Feedback Program (PFP) | Change in Cannabis Use | 5 Participants |
| Brief Motivational Intervention (BMI) | Change in Cannabis Use | 12 Participants |
| Combined PFP+BMI | Change in Cannabis Use | 19 Participants |
Mental Health as Assessed Using 8-item Questionnaire
Anxiety 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.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Resources Program (RP) | Mental Health as Assessed Using 8-item Questionnaire | Anxiety | 5.12 score on a scale | Standard Deviation 4.12 |
| Resources Program (RP) | Mental Health as Assessed Using 8-item Questionnaire | Depression | 7.06 score on a scale | Standard Deviation 3.68 |
| Personalized Feedback Program (PFP) | Mental Health as Assessed Using 8-item Questionnaire | Depression | 6.46 score on a scale | Standard Deviation 3.9 |
| Personalized Feedback Program (PFP) | Mental Health as Assessed Using 8-item Questionnaire | Anxiety | 2.98 score on a scale | Standard Deviation 3.42 |
| Brief Motivational Intervention (BMI) | Mental Health as Assessed Using 8-item Questionnaire | Anxiety | 4.00 score on a scale | Standard Deviation 3.59 |
| Brief Motivational Intervention (BMI) | Mental Health as Assessed Using 8-item Questionnaire | Depression | 7.06 score on a scale | Standard Deviation 4.35 |
| Combined PFP+BMI | Mental Health as Assessed Using 8-item Questionnaire | Anxiety | 4.32 score on a scale | Standard Deviation 4.35 |
| Combined PFP+BMI | Mental Health as Assessed Using 8-item Questionnaire | Depression | 7.09 score on a scale | Standard Deviation 4.8 |
Program Satisfaction
Ten 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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Program (RP) | Program Satisfaction | 4.4 score on a scale | Standard Deviation 3.68 |
| Personalized Feedback Program (PFP) | Program Satisfaction | 3.83 score on a scale | Standard Deviation 2.57 |
| Brief Motivational Intervention (BMI) | Program Satisfaction | 3.3 score on a scale | Standard Deviation 3.38 |
| Combined PFP+BMI | Program Satisfaction | 4.3 score on a scale | Standard Deviation 2.82 |
Resource Use
Participants 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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Program (RP) | Resource Use | 2 number of resources | Standard Deviation 1.79 |
| Personalized Feedback Program (PFP) | Resource Use | 2.2 number of resources | Standard Deviation 2.23 |
| Brief Motivational Intervention (BMI) | Resource Use | 1.52 number of resources | Standard Deviation 1.53 |
| Combined PFP+BMI | Resource Use | 2.02 number of resources | Standard Deviation 2.09 |
Risk Comprehension as Assessed Using 10-item Questionnaire
Risk 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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Program (RP) | Risk Comprehension as Assessed Using 10-item Questionnaire | 8.33 score on a scale | Standard Deviation 1.5 |
| Personalized Feedback Program (PFP) | Risk Comprehension as Assessed Using 10-item Questionnaire | 8.41 score on a scale | Standard Deviation 1.78 |
| Brief Motivational Intervention (BMI) | Risk Comprehension as Assessed Using 10-item Questionnaire | 8.53 score on a scale | Standard Deviation 1.25 |
| Combined PFP+BMI | Risk Comprehension as Assessed Using 10-item Questionnaire | 8.65 score on a scale | Standard Deviation 1.42 |
Well-being as Assessed Using 14-item Questionnaire
Well-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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Program (RP) | Well-being as Assessed Using 14-item Questionnaire | 2.91 score on a scale | Standard Deviation 0.95 |
| Personalized Feedback Program (PFP) | Well-being as Assessed Using 14-item Questionnaire | 2.98 score on a scale | Standard Deviation 0.99 |
| Brief Motivational Intervention (BMI) | Well-being as Assessed Using 14-item Questionnaire | 2.98 score on a scale | Standard Deviation 1.12 |
| Combined PFP+BMI | Well-being as Assessed Using 14-item Questionnaire | 2.9 score on a scale | Standard Deviation 1.07 |