Personalized Feedback Programs for College Students
Primary Purpose
Alcohol Use, Unspecified
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resources
Personalized Feedback Program (PFP)
Substance Use Feedback Program (BMI)
Sponsored by

About this trial
This is an interventional prevention trial for Alcohol Use, Unspecified
Eligibility Criteria
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
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Active Comparator
Active Comparator
Active Comparator
Arm Label
Resources Program (RP)
Personalized Feedback Program (PFP)
Brief motivational intervention (BMI)
Combined PFP+BMI
Arm Description
Outcomes
Primary Outcome Measures
Change in Alcohol Use
Number of participants who report alcohol use in the past 30 days
Change in Cannabis Use
Number of participants who report cannabis use in the past 30 days
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04975191
First Posted
July 20, 2021
Last Updated
May 9, 2023
Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT04975191
Brief Title
Personalized Feedback Programs for College Students
Official Title
Personalized Feedback Programs for College Students
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 29, 2021 (Actual)
Primary Completion Date
March 23, 2022 (Actual)
Study Completion Date
March 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, Unspecified
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resources Program (RP)
Arm Type
Other
Arm Title
Personalized Feedback Program (PFP)
Arm Type
Active Comparator
Arm Title
Brief motivational intervention (BMI)
Arm Type
Active Comparator
Arm Title
Combined PFP+BMI
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Resources
Intervention Description
Participants will be provided a list of resources available at VCU that are intended to support student success
Intervention Type
Behavioral
Intervention Name(s)
Personalized Feedback Program (PFP)
Intervention Description
Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
Intervention Type
Behavioral
Intervention Name(s)
Substance Use Feedback Program (BMI)
Intervention Description
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 Outcome Measure Information:
Title
Change in Alcohol Use
Description
Number of participants who report alcohol use in the past 30 days
Time Frame
Baseline-3 months
Title
Change in Cannabis Use
Description
Number of participants who report cannabis use in the past 30 days
Time Frame
Baseline-3 months
Secondary Outcome Measure Information:
Title
Well-being as Assessed Using 14-item Questionnaire
Description
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
Title
Mental Health as Assessed Using 8-item Questionnaire
Description
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
Title
Resource Use
Description
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
Title
Program Satisfaction
Description
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
Title
Risk Comprehension as Assessed Using 10-item Questionnaire
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Langberg, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
result
PubMed Identifier
4682398
Citation
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.
Results Reference
result
PubMed Identifier
20973032
Citation
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.
Results Reference
result
Learn more about this trial
Personalized Feedback Programs for College Students
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