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| ID | Type | Description | Link |
|---|---|---|---|
| R34AA027347 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resources Program (RP) | Other |
| |
| Personalized Feedback Program (PFP) | Active Comparator |
| |
| Brief motivational intervention (BMI) | Active Comparator |
| |
| Combined PFP+BMI | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resources | Behavioral | Participants will be provided a list of resources available at VCU that are intended to support student success |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alcohol Use | Number of participants who report alcohol use in the past 30 days | Baseline-3 months |
| Change in Cannabis Use | Number of participants who report cannabis use in the past 30 days | Baseline-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Langberg, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Keyes, C. L. (2009). Brief description of the mental health continuum short form (MHC-SF). Scale retrieved from https://www.psytoolkit.org/survey-library/mhc-sf.html. | ||
| 4682398 | Result | Derogatis LR, Lipman RS, Covi L. SCL-90: an outpatient psychiatric rating scale--preliminary report. Psychopharmacol Bull. 1973 Jan;9(1):13-28. No abstract available. | |
| 20973032 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Resources Program (RP) | Resources: Participants will be provided a list of resources available at VCU that are intended to support student success |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not-completers lost to follow were included in baseline data analysis but not-completers due to protocol violations were not.
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| ID | Title | Description |
|---|---|---|
| BG000 | Resources Program (RP) | Resources: Participants will be provided a list of resources available at VCU that are intended to support student success |
| BG001 | Personalized Feedback Program (PFP) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Alcohol Use | Number of participants who report alcohol use in the past 30 days | Posted | Count of Participants | Participants | Baseline-3 months |
|
NA - Adverse event data was not collected
Adverse events data was not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Resources Program (RP) | Resources: Participants will be provided a list of resources available at VCU that are intended to support student success |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Danielle Dick | Rutgers University | 732-235-5607 | Danielle.M.Dick@rutgers.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2021 | Feb 9, 2023 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2021 | May 17, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D006295 | Health Resources |
| D015992 | Body Mass Index |
| ID | Term |
|---|---|
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D003695 | Delivery of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Personalized Feedback Program (PFP) | Behavioral | Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success |
|
| Substance Use Feedback Program (BMI) | Behavioral | 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 |
|
| 3 months |
| 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. | 3 months |
| 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. | 3 months |
| 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. | 3 months |
| 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. | 3 months |
| Result |
| Lamers SM, Westerhof GJ, Bohlmeijer ET, ten Klooster PM, Keyes CL. Evaluating the psychometric properties of the Mental Health Continuum-Short Form (MHC-SF). J Clin Psychol. 2011 Jan;67(1):99-110. doi: 10.1002/jclp.20741. |
| Lost to Follow-up |
|
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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 |
| OG003 | 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 |
|
|
| Primary | Change in Cannabis Use | Number of participants who report cannabis use in the past 30 days | Posted | Count of Participants | Participants | Baseline-3 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | number of resources | 3 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |
| D001699 | Biometry |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Depression |
|