Personalized Feedback Programs for College Students

Alcohol Use, Unspecified Clinical Trial

Official title:

Personalized Feedback Programs for College Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04975191
• Other study ID #: HM20022611
• Secondary ID: R34AA027347
• Status: Completed
• Phase: N/A
• Start date: August 29, 2021
• Est. completion date: March 23, 2022

Study information

• Verified date: May 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: March 23, 2022
• Est. primary completion date: March 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use, Unspecified

Intervention

Behavioral:
• Resources
Participants will be provided a list of resources available at VCU that are intended to support student success
• 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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alcohol Use	Number of participants who report alcohol use in the past 30 days	Baseline-3 months
Primary	Change in Cannabis Use	Number of participants who report cannabis use in the past 30 days	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.	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.	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.	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.	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.	3 months