- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04975191
Personalized Feedback Programs for College Students
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Resources Program (RP)
|
Participants will be provided a list of resources available at VCU that are intended to support student success
|
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Active Comparator: Personalized Feedback Program (PFP)
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Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
|
|
Active Comparator: Brief motivational intervention (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
|
|
Active Comparator: Combined PFP+BMI
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Alcohol Use
Time Frame: Baseline-3 months
|
Number of participants who report alcohol use in the past 30 days
|
Baseline-3 months
|
|
Change in Cannabis Use
Time Frame: Baseline-3 months
|
Number of participants who report cannabis use in the past 30 days
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Baseline-3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Well-being as Assessed Using 14-item Questionnaire
Time Frame: 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.
|
3 months
|
|
Mental Health as Assessed Using 8-item Questionnaire
Time Frame: 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.
|
3 months
|
|
Resource Use
Time Frame: 3 months
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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
Time Frame: 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.
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3 months
|
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Risk Comprehension as Assessed Using 10-item Questionnaire
Time Frame: 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.
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3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joshua Langberg, PhD, Virginia Commonwealth University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20022611
- R34AA027347 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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