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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Alcohol Use, Unspecified
- 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 group | Role | What they receive |
|---|---|---|
| Resources Program (RP) | Other | Not described Receives: Behavioral: Resources |
| Personalized Feedback Program (PFP) | Active comparator | Not described Receives: Behavioral: Personalized Feedback Program (PFP) |
| Brief motivational intervention (BMI) | Active comparator | Not described Receives: Behavioral: Substance Use Feedback Program (BMI) |
| Combined PFP+BMI | Active comparator | Not 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.
Change in Alcohol Use
Number of participants who report alcohol use in the past 30 days
Measured: Baseline-3 months
Change in Cannabis Use
Number of participants who report cannabis use in the past 30 days
Measured: Baseline-3 months
Secondary outcomes (5)
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
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
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
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
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.
- First posted23 Jul 2021
- Study start29 Aug 2021
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Joshua Langberg, PhD, Principal investigator, Virginia Commonwealth University
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 4682398Lamers 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
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Feedback Programs for College Students
- ClinicalTrials.gov ID
- NCT04975191
- Acronym / sponsor ID
- HM20022611
- Conditions
- Alcohol Use, Unspecified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 29 Aug 2021 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Posted 31 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Resources Program (RP) | Other | Behavioral: Resources |
| Personalized Feedback Program (PFP) | Active comparator | Behavioral: Personalized Feedback Program (PFP) |
| Brief motivational intervention (BMI) | Active comparator | Behavioral: Substance Use Feedback Program (BMI) |
| Combined PFP+BMI | Active comparator | Behavioral: Personalized Feedback Program (PFP), Behavioral: Substance Use Feedback Program (BMI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Age: Under the age of 18
- Year in College: A sophomore, junior or senior
- Enrollment Status: Enrolled part-time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResourcesParticipants will be provided a list of resources available at VCU that are intended to support student success | Behavioural | Resources Program (RP) |
| Personalized Feedback Program (PFP)Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success | Behavioural | Combined PFP+BMI, Personalized Feedback Program (PFP) |
| 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 | Behavioural | Brief motivational intervention (BMI), Combined PFP+BMI |
Primary outcome
Change in Alcohol Use
Time frame: Baseline-3 months
Number of participants who report alcohol use in the past 30 days
Change in Cannabis Use
Time frame: Baseline-3 months
Number of participants who report cannabis use in the past 30 days
5 secondary outcomes
Well-being as Assessed Using 14-item Questionnaire
Time frame: 3 months
Mental Health as Assessed Using 8-item Questionnaire
Time frame: 3 months
Resource Use
Time frame: 3 months
Program Satisfaction
Time frame: 3 months
Risk Comprehension as Assessed Using 10-item Questionnaire
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationKeyes, 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 publication: PubMed 4682398Derogatis 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 publication: PubMed 20973032Lamers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Langberg, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
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.