AzTrials
AzTrials

Alcohol Use, UnspecifiedNCT04975191

Personalized Feedback Programs for College Students

A study testing Resources, Personalized Feedback Program (PFP) and Substance Use Feedback Program (BMI) in people with Alcohol Use, Unspecified, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Alcohol Use, Unspecified
What is being tested?
Resources, Personalized Feedback Program (PFP) and Substance Use Feedback Program (BMI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
1 siteUnited States
Study dates
29 Aug 2021to 23 Mar 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Age: Under the age of 18
  • Year in College: A sophomore, junior or senior
  • Enrollment Status: Enrolled part-time

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

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.

Read the 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.

Being tested
Resources, Personalized Feedback Program (PFP), Substance Use Feedback Program (BMI)
Medical subject headings
Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ResourcesBehavioural

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

  • Personalized Feedback Program (PFP)Behavioural

    Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success

  • Substance Use Feedback Program (BMI)Behavioural

    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

Study groups in NCT04975191
Study groupRoleWhat they receive
Resources Program (RP)OtherNot described
Receives: Behavioral: Resources
Personalized Feedback Program (PFP)Active comparatorNot described
Receives: Behavioral: Personalized Feedback Program (PFP)
Brief motivational intervention (BMI)Active comparatorNot described
Receives: Behavioral: Substance Use Feedback Program (BMI)
Combined PFP+BMIActive comparatorNot described
Receives: Behavioral: Personalized Feedback Program (PFP); Behavioral: Substance Use Feedback Program (BMI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Alcohol Use

    Number of participants who report alcohol use in the past 30 days

    Measured: Baseline-3 months

  2. Change in Cannabis Use

    Number of participants who report cannabis use in the past 30 days

    Measured: Baseline-3 months

Secondary outcomes (5)
  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

  3. 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.

    Measured: 3 months

  4. 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.

    Measured: 3 months

  5. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2021
  2. Study start29 Aug 2021
  3. Primary completion23 Mar 2022
  4. Study completion23 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04975191
Sponsor's protocol ID
HM20022611
Other IDs
R34AA027347
Status last verified
May 2023
First submitted
20 Jul 2021
Last updated
31 May 2023
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 4682398
  • 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.

    PubMed 20973032

Questions about this trial

What is this clinical trial studying?

A study testing Resources, Personalized Feedback Program (PFP) and Substance Use Feedback Program (BMI) in people with Alcohol Use, Unspecified, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Alcohol Use (time frame: Baseline-3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04975191, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in