Personalized Feedback Programs for College Students

May 9, 2023 updated by: Virginia Commonwealth University
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.

Study Overview

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

Interventional

Enrollment (Actual)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: Personalized Feedback Program (PFP)
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
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
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
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joshua Langberg, PhD, Virginia Commonwealth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2021

Primary Completion (Actual)

March 23, 2022

Study Completion (Actual)

March 23, 2022

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

July 22, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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